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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT02296138
Registration number
NCT02296138
Ethics application status
Date submitted
19/11/2014
Date registered
20/11/2014
Date last updated
4/06/2018
Titles & IDs
Public title
Comparing the Efficacy of Tiotropium + Olodaterol (5/5 µg) Fixed Dose Combination (FDC) Over Tiotropium 5µg in Reducing Moderate to Severe Exacerbations in Patients With Severe to Very Severe Chronic Obstructive Pulmonary Disease.
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Scientific title
A Randomised, Double-blind, Active-controlled Parallel Group Study to Evaluate the Effect of 52 Weeks of Once Daily Treatment of Orally Inhaled Tiotropium + Olodaterol Fixed Dose Combination Compared With Tiotropium on Chronic Obstructive Pulmonary Disease (COPD) Exacerbation in Patients With Severe to Very Severe COPD. [DYNAGITO]
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Secondary ID [1]
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2014-002275-28
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Secondary ID [2]
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1237.19
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Pulmonary Disease, Chronic Obstructive
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Condition category
Condition code
Respiratory
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Chronic obstructive pulmonary disease
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - olodaterol
Treatment: Drugs - tiotropium
Experimental: tiotropium + olodaterol high dose - Once daily 2 puffs solution for inhalation Respimat
Active comparator: tiotropium - Once daily 2 puffs solution for inhalation Respimat
Treatment: Drugs: olodaterol
fixed dose combination
Treatment: Drugs: tiotropium
fixed dose combination
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Annualised Rate of Moderate to Severe COPD Exacerbations During the Actual Treatment Period.
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Assessment method [1]
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Annualised rate of moderate to severe COPD exacerbations during the actual treatment period was calculated per treatment per patient-year. The actual treatment period was defined as the interval from first in-take of study medication until 1 day after last in-take of study medication. Least Squares Means are actually exponentiated.
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Timepoint [1]
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From first in-take of study medication until 1 day after last in-take of study medication, up to 361 days
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Secondary outcome [1]
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Number of Patients With at Least One Moderate to Severe COPD Exacerbation During the Actual Treatment Period.
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Assessment method [1]
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Key secondary endpoint: Number of patients with at least one moderate to severe COPD exacerbation during the actual treatment period per treatment. The actual treatment period was defined as the interval from first in-take of study medication until 1 day after last in-take of study medication. The median was not estimated due to less than 50% of patients having an event. Hence the number of patients with at least one moderate to severe COPD exacerbation is presented.
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Timepoint [1]
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From first in-take of study medication until 1 day after last in-take of study medication, up to 361 days
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Secondary outcome [2]
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Annualised Rate of Exacerbations Leading to Hospitalisation During the Actual Treatment Period.
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Assessment method [2]
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Annualised rate of exacerbations leading to hospitalisation during the actual treatment period was calculated per treatment per patient-year. The actual treatment period was defined as the interval from first in-take of study medication until 1 day after last in-take of study medication.
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Timepoint [2]
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From first in-take of study medication until 1 day after last in-take of study medication, up to 361 days
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Secondary outcome [3]
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Number of Patients With at Least One COPD Exacerbation Leading to Hospitalisation During the Actual Treatment Period.
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Assessment method [3]
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Number of patients with at least one COPD exacerbation leading to hospitalisation during the actual treatment period per treatment. The actual treatment period was defined as the interval from first in-take of study medication until 1 day after last in-take of study medication. The median was not estimated due to less than 50% of patients having an event. Hence the number of patients with at least one moderate to severe COPD exacerbation leading to hospitalisation is presented.
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Timepoint [3]
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From first in-take of study medication until 1 day after last in-take of study medication, up to 361 days
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Secondary outcome [4]
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Number of Patients With All-cause Mortality Occurring During the Actual Treatment Period.
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Assessment method [4]
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Number of patients with all-cause mortality occurring during the actual treatment period per treatment. The actual treatment period was defined as the interval from first in-take of study medication until 1 day after last in-take of study medication. The median was not estimated due to less than 50% of patients having an event. Hence the number of patients with all-cause mortality is presented.
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Timepoint [4]
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From first in-take of study medication until 1 day after last in-take of study medication, up to 361 days
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Eligibility
Key inclusion criteria
Inclusion criteria:
* Male or female patients, 40 years of age or older.
* Diagnosis of COPD with a documented post-bronchodilator Forced expiratory volume in one second (FEV1)< 60% of predicted normal and a post-bronchodilator FEV1/ forced vital capacity (FVC) <70% at Visit 1
* Documented history of at least one moderate to severe COPD exacerbation in the previous 12 months requiring treatment with systemic corticosteroids and/or antibiotics and/or related hospitalization.
* Symptomatically stable as defined by: no evidence of COPD exacerbation requiring use of either antibiotics and/or steroids 4 weeks prior to visit 1 and no evidence of change in their usual COPD medication 4 weeks prior to visit 1.
* Current or ex-smokers with a smoking history of more than 10 pack years.
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Minimum age
40
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Exclusion criteria:
* Significant disease other than COPD.
* Clinically relevant abnormal baseline haematology, blood chemistry or creatinine > x2 ULN will be excluded regardless of clinical condition. ( A repeat laboratory evaluation can be conducted if deemed necessary by the investigator.)
* Current documented diagnosis of asthma. For patients with allergic rhinitis or atopy, source documentation is required to verify that the patient does not have asthma
* A diagnosis of thyrotoxicosis
* A history of myocardial infarction within 6 months of screening visit.
* Life-threatening cardiac arrhythmia.
* Known active tuberculosis.
* Any malignancy unless free of disease for at least 5 years (patients with treated basal cell carcinoma or squamous cell skin cancers are allowed).
* A history of cystic fibrosis.
* Clinically relevant bronchiectasis.
* Patients with severe emphysema requiring endobronchial interventions within 6 months prior to screening
* A history of significant alcohol or drug abuse in the opinion of the investigator.
* Patients who have undergone thoracotomy with pulmonary resection
* Patients being treated with oral or patch ß-adrenergics.
* Patients being treated with oral corticosteroid medication at unstable doses
* Patients being treated with antibiotics for any reasons within 4 weeks of screening visit
* Patients being treated with PDE4 inhibitors within 3 months of screening visit
* Patients who have taken an investigational drug within one month or six half-lives
* Pregnant or nursing women.
* Women of childbearing potential not using a highly effective method of birth control.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
13/01/2015
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
29/03/2017
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Sample size
Target
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Accrual to date
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Final
7903
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
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Recruitment hospital [1]
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1237.19.61012 Boehringer Ingelheim Investigational Site - Campbelltown
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Recruitment hospital [2]
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1237.19.61011 Boehringer Ingelheim Investigational Site - Kogarah
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1237.19.61008 Boehringer Ingelheim Investigational Site - Randwick
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1237.19.61010 Boehringer Ingelheim Investigational Site - Cairns
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1237.19.61006 Boehringer Ingelheim Investigational Site - Chermside
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1237.19.61001 Boehringer Ingelheim Investigational Site - Daw Park
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1237.19.61002 Boehringer Ingelheim Investigational Site - Kent Town
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1237.19.61007 Boehringer Ingelheim Investigational Site - Woodville
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1237.19.61013 Boehringer Ingelheim Investigational Site - Box Hill
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1237.19.61003 Boehringer Ingelheim Investigational Site - Melbourne
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1237.19.61009 Boehringer Ingelheim Investigational Site - Parkville
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Recruitment hospital [12]
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1237.19.61004 Boehringer Ingelheim Investigational Site - Murdoch
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Recruitment postcode(s) [1]
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- Campbelltown
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- Kogarah
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- Randwick
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- Daw Park
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- Kent Town
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- Woodville
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- Box Hill
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- Melbourne
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- Parkville
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Recruitment postcode(s) [12]
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- Murdoch
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Recruitment outside Australia
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0
0
Kolding
Query!
Country [106]
0
0
Denmark
Query!
State/province [106]
0
0
Odense
Query!
Country [107]
0
0
Denmark
Query!
State/province [107]
0
0
Roskilde
Query!
Country [108]
0
0
Denmark
Query!
State/province [108]
0
0
Vaerløse
Query!
Country [109]
0
0
Denmark
Query!
State/province [109]
0
0
Ålborg
Query!
Country [110]
0
0
Finland
Query!
State/province [110]
0
0
Helsinki
Query!
Country [111]
0
0
Finland
Query!
State/province [111]
0
0
Oulu
Query!
Country [112]
0
0
Finland
Query!
State/province [112]
0
0
Turku
Query!
Country [113]
0
0
France
Query!
State/province [113]
0
0
Cannes
Query!
Country [114]
0
0
France
Query!
State/province [114]
0
0
La Tronche
Query!
Country [115]
0
0
France
Query!
State/province [115]
0
0
MARSEILLE Cedex 08
Query!
Country [116]
0
0
France
Query!
State/province [116]
0
0
Marseille
Query!
Country [117]
0
0
France
Query!
State/province [117]
0
0
Montpellier cedex 5
Query!
Country [118]
0
0
France
Query!
State/province [118]
0
0
Nantes Cedex 01
Query!
Country [119]
0
0
France
Query!
State/province [119]
0
0
Nice
Query!
Country [120]
0
0
France
Query!
State/province [120]
0
0
Nîmes cedex 9
Query!
Country [121]
0
0
France
Query!
State/province [121]
0
0
Nîmes
Query!
Country [122]
0
0
France
Query!
State/province [122]
0
0
Paris
Query!
Country [123]
0
0
France
Query!
State/province [123]
0
0
Pessac
Query!
Country [124]
0
0
France
Query!
State/province [124]
0
0
Reims
Query!
Country [125]
0
0
France
Query!
State/province [125]
0
0
Rennes Cedex 9
Query!
Country [126]
0
0
France
Query!
State/province [126]
0
0
Saint Laurent du Var
Query!
Country [127]
0
0
France
Query!
State/province [127]
0
0
Saint Pierre - La Réunion
Query!
Country [128]
0
0
France
Query!
State/province [128]
0
0
Strasbourg
Query!
Country [129]
0
0
France
Query!
State/province [129]
0
0
Toulouse cedex 9
Query!
Country [130]
0
0
France
Query!
State/province [130]
0
0
TOURS Cedex 9
Query!
Country [131]
0
0
France
Query!
State/province [131]
0
0
Vieux Condé
Query!
Country [132]
0
0
Germany
Query!
State/province [132]
0
0
Ahlen
Query!
Country [133]
0
0
Germany
Query!
State/province [133]
0
0
Aschaffenburg
Query!
Country [134]
0
0
Germany
Query!
State/province [134]
0
0
Augsburg
Query!
Country [135]
0
0
Germany
Query!
State/province [135]
0
0
Bad Wörishofen
Query!
Country [136]
0
0
Germany
Query!
State/province [136]
0
0
Bamberg
Query!
Country [137]
0
0
Germany
Query!
State/province [137]
0
0
Bergisch Gladbach
Query!
Country [138]
0
0
Germany
Query!
State/province [138]
0
0
Berlin
Query!
Country [139]
0
0
Germany
Query!
State/province [139]
0
0
Bielefeld
Query!
Country [140]
0
0
Germany
Query!
State/province [140]
0
0
Bochum
Query!
Country [141]
0
0
Germany
Query!
State/province [141]
0
0
Bonn
Query!
Country [142]
0
0
Germany
Query!
State/province [142]
0
0
Düren
Query!
Country [143]
0
0
Germany
Query!
State/province [143]
0
0
Essen
Query!
Country [144]
0
0
Germany
Query!
State/province [144]
0
0
Frankfurt
Query!
Country [145]
0
0
Germany
Query!
State/province [145]
0
0
Fulda
Query!
Country [146]
0
0
Germany
Query!
State/province [146]
0
0
Fürstenwalde
Query!
Country [147]
0
0
Germany
Query!
State/province [147]
0
0
Großhansdorf
Query!
Country [148]
0
0
Germany
Query!
State/province [148]
0
0
Gütersloh
Query!
Country [149]
0
0
Germany
Query!
State/province [149]
0
0
Halle/Saale
Query!
Country [150]
0
0
Germany
Query!
State/province [150]
0
0
Hamburg
Query!
Country [151]
0
0
Germany
Query!
State/province [151]
0
0
Hannover
Query!
Country [152]
0
0
Germany
Query!
State/province [152]
0
0
Heidelberg
Query!
Country [153]
0
0
Germany
Query!
State/province [153]
0
0
Höchstädt
Query!
Country [154]
0
0
Germany
Query!
State/province [154]
0
0
Kiel
Query!
Country [155]
0
0
Germany
Query!
State/province [155]
0
0
Koblenz
Query!
Country [156]
0
0
Germany
Query!
State/province [156]
0
0
Köln
Query!
Country [157]
0
0
Germany
Query!
State/province [157]
0
0
Landsberg am Lech
Query!
Country [158]
0
0
Germany
Query!
State/province [158]
0
0
Leipzig
Query!
Country [159]
0
0
Germany
Query!
State/province [159]
0
0
Leverkusen
Query!
Country [160]
0
0
Germany
Query!
State/province [160]
0
0
Lübeck
Query!
Country [161]
0
0
Germany
Query!
State/province [161]
0
0
Mannheim
Query!
Country [162]
0
0
Germany
Query!
State/province [162]
0
0
Marburg
Query!
Country [163]
0
0
Germany
Query!
State/province [163]
0
0
Minden
Query!
Country [164]
0
0
Germany
Query!
State/province [164]
0
0
München
Query!
Country [165]
0
0
Germany
Query!
State/province [165]
0
0
Paderborn
Query!
Country [166]
0
0
Germany
Query!
State/province [166]
0
0
Peine
Query!
Country [167]
0
0
Germany
Query!
State/province [167]
0
0
Potsdam
Query!
Country [168]
0
0
Germany
Query!
State/province [168]
0
0
Radebeul
Query!
Country [169]
0
0
Germany
Query!
State/province [169]
0
0
Rheine
Query!
Country [170]
0
0
Germany
Query!
State/province [170]
0
0
Rüdersdorf
Query!
Country [171]
0
0
Germany
Query!
State/province [171]
0
0
Solingen
Query!
Country [172]
0
0
Germany
Query!
State/province [172]
0
0
Teuchern
Query!
Country [173]
0
0
Germany
Query!
State/province [173]
0
0
Wardenburg
Query!
Country [174]
0
0
Germany
Query!
State/province [174]
0
0
Wiesloch
Query!
Country [175]
0
0
Germany
Query!
State/province [175]
0
0
Witten
Query!
Country [176]
0
0
Greece
Query!
State/province [176]
0
0
Athens
Query!
Country [177]
0
0
Greece
Query!
State/province [177]
0
0
Heraklion
Query!
Country [178]
0
0
Greece
Query!
State/province [178]
0
0
Nafplio
Query!
Country [179]
0
0
Greece
Query!
State/province [179]
0
0
Serres
Query!
Country [180]
0
0
Greece
Query!
State/province [180]
0
0
Thessaloniki
Query!
Country [181]
0
0
Guatemala
Query!
State/province [181]
0
0
Guatemala
Query!
Country [182]
0
0
Hong Kong
Query!
State/province [182]
0
0
Hong Kong
Query!
Country [183]
0
0
Hungary
Query!
State/province [183]
0
0
Budapest
Query!
Country [184]
0
0
Hungary
Query!
State/province [184]
0
0
Debrecen
Query!
Country [185]
0
0
Hungary
Query!
State/province [185]
0
0
Edeleny
Query!
Country [186]
0
0
Hungary
Query!
State/province [186]
0
0
Farkasgyepu
Query!
Country [187]
0
0
Hungary
Query!
State/province [187]
0
0
Godollo
Query!
Country [188]
0
0
Hungary
Query!
State/province [188]
0
0
Hajdunanas
Query!
Country [189]
0
0
Hungary
Query!
State/province [189]
0
0
Kapuvar
Query!
Country [190]
0
0
Hungary
Query!
State/province [190]
0
0
Komarom
Query!
Country [191]
0
0
Hungary
Query!
State/province [191]
0
0
Nyiregyhaza
Query!
Country [192]
0
0
Hungary
Query!
State/province [192]
0
0
Pecs
Query!
Country [193]
0
0
Hungary
Query!
State/province [193]
0
0
Szazhalombatta
Query!
Country [194]
0
0
Hungary
Query!
State/province [194]
0
0
Szeged
Query!
Country [195]
0
0
India
Query!
State/province [195]
0
0
Ahmadabad
Query!
Country [196]
0
0
India
Query!
State/province [196]
0
0
Ahmedabad
Query!
Country [197]
0
0
India
Query!
State/province [197]
0
0
Bangalore
Query!
Country [198]
0
0
India
Query!
State/province [198]
0
0
Coimbatore
Query!
Country [199]
0
0
India
Query!
State/province [199]
0
0
Gurgaon
Query!
Country [200]
0
0
India
Query!
State/province [200]
0
0
Hyderabad
Query!
Country [201]
0
0
India
Query!
State/province [201]
0
0
Jaipur
Query!
Country [202]
0
0
India
Query!
State/province [202]
0
0
Karamsad
Query!
Country [203]
0
0
India
Query!
State/province [203]
0
0
Kolkata
Query!
Country [204]
0
0
India
Query!
State/province [204]
0
0
Ludhiana
Query!
Country [205]
0
0
India
Query!
State/province [205]
0
0
Madurai
Query!
Country [206]
0
0
India
Query!
State/province [206]
0
0
Mysore
Query!
Country [207]
0
0
India
Query!
State/province [207]
0
0
Nagpur
Query!
Country [208]
0
0
India
Query!
State/province [208]
0
0
New Delhi
Query!
Country [209]
0
0
India
Query!
State/province [209]
0
0
Panjim
Query!
Country [210]
0
0
India
Query!
State/province [210]
0
0
Pune
Query!
Country [211]
0
0
India
Query!
State/province [211]
0
0
Vellore
Query!
Country [212]
0
0
India
Query!
State/province [212]
0
0
Vishakhapatnam
Query!
Country [213]
0
0
Ireland
Query!
State/province [213]
0
0
Dublin 24
Query!
Country [214]
0
0
Ireland
Query!
State/province [214]
0
0
Wilton
Query!
Country [215]
0
0
Italy
Query!
State/province [215]
0
0
Cittadella (PD)
Query!
Country [216]
0
0
Italy
Query!
State/province [216]
0
0
Ferrara
Query!
Country [217]
0
0
Italy
Query!
State/province [217]
0
0
Messina
Query!
Country [218]
0
0
Italy
Query!
State/province [218]
0
0
Milano
Query!
Country [219]
0
0
Italy
Query!
State/province [219]
0
0
Monza
Query!
Country [220]
0
0
Italy
Query!
State/province [220]
0
0
Padova
Query!
Country [221]
0
0
Italy
Query!
State/province [221]
0
0
Palermo
Query!
Country [222]
0
0
Italy
Query!
State/province [222]
0
0
Parma
Query!
Country [223]
0
0
Italy
Query!
State/province [223]
0
0
Pavia
Query!
Country [224]
0
0
Italy
Query!
State/province [224]
0
0
Perugia
Query!
Country [225]
0
0
Italy
Query!
State/province [225]
0
0
Piacenza
Query!
Country [226]
0
0
Italy
Query!
State/province [226]
0
0
Pisa
Query!
Country [227]
0
0
Italy
Query!
State/province [227]
0
0
Pordenone
Query!
Country [228]
0
0
Italy
Query!
State/province [228]
0
0
Roma
Query!
Country [229]
0
0
Italy
Query!
State/province [229]
0
0
San Pietro Vernotico (BR)
Query!
Country [230]
0
0
Italy
Query!
State/province [230]
0
0
Sassari
Query!
Country [231]
0
0
Italy
Query!
State/province [231]
0
0
Scafati (SA)
Query!
Country [232]
0
0
Japan
Query!
State/province [232]
0
0
Aichi, Komaki
Query!
Country [233]
0
0
Japan
Query!
State/province [233]
0
0
Aichi, Nagoya
Query!
Country [234]
0
0
Japan
Query!
State/province [234]
0
0
Aichi, Obu
Query!
Country [235]
0
0
Japan
Query!
State/province [235]
0
0
Aichi, Seto
Query!
Country [236]
0
0
Japan
Query!
State/province [236]
0
0
Chiba, Chiba
Query!
Country [237]
0
0
Japan
Query!
State/province [237]
0
0
Chiba, Kamogawa
Query!
Country [238]
0
0
Japan
Query!
State/province [238]
0
0
Fukui, Fukui
Query!
Country [239]
0
0
Japan
Query!
State/province [239]
0
0
Fukuoka, Fukuoka
Query!
Country [240]
0
0
Japan
Query!
State/province [240]
0
0
Fukuoka, Kitakyushu-city
Query!
Country [241]
0
0
Japan
Query!
State/province [241]
0
0
Fukuoka, Koga
Query!
Country [242]
0
0
Japan
Query!
State/province [242]
0
0
Fukuoka, Kurume
Query!
Country [243]
0
0
Japan
Query!
State/province [243]
0
0
Fukuoka, Yanagawa
Query!
Country [244]
0
0
Japan
Query!
State/province [244]
0
0
Fukuoka, Yukuhashi
Query!
Country [245]
0
0
Japan
Query!
State/province [245]
0
0
Fukushima, Fukushima
Query!
Country [246]
0
0
Japan
Query!
State/province [246]
0
0
Gifu, Mizunami
Query!
Country [247]
0
0
Japan
Query!
State/province [247]
0
0
Gifu, Ogaki
Query!
Country [248]
0
0
Japan
Query!
State/province [248]
0
0
Gunma, Fujioka
Query!
Country [249]
0
0
Japan
Query!
State/province [249]
0
0
Gunma, Maebashi
Query!
Country [250]
0
0
Japan
Query!
State/province [250]
0
0
Gunma, Takasaki
Query!
Country [251]
0
0
Japan
Query!
State/province [251]
0
0
Hiroshima, Fukuyama
Query!
Country [252]
0
0
Japan
Query!
State/province [252]
0
0
Hiroshima, Hiroshima
Query!
Country [253]
0
0
Japan
Query!
State/province [253]
0
0
Hiroshima, Kure
Query!
Country [254]
0
0
Japan
Query!
State/province [254]
0
0
Hokkaido, Asahikawa
Query!
Country [255]
0
0
Japan
Query!
State/province [255]
0
0
Hokkaido, Chitose
Query!
Country [256]
0
0
Japan
Query!
State/province [256]
0
0
Hokkaido, Hakodate
Query!
Country [257]
0
0
Japan
Query!
State/province [257]
0
0
Hokkaido, Obihiro
Query!
Country [258]
0
0
Japan
Query!
State/province [258]
0
0
Hokkaido, Otaru
Query!
Country [259]
0
0
Japan
Query!
State/province [259]
0
0
Hokkaido, Sapporo
Query!
Country [260]
0
0
Japan
Query!
State/province [260]
0
0
Hokkaido, Tomakomai
Query!
Country [261]
0
0
Japan
Query!
State/province [261]
0
0
Hyogo, Himeji
Query!
Country [262]
0
0
Japan
Query!
State/province [262]
0
0
Hyogo, Kobe
Query!
Country [263]
0
0
Japan
Query!
State/province [263]
0
0
Hyogo, Nishinomiya
Query!
Country [264]
0
0
Japan
Query!
State/province [264]
0
0
Ibaraki, Hitachinaka
Query!
Country [265]
0
0
Japan
Query!
State/province [265]
0
0
Ibaraki, Inashiki-gun
Query!
Country [266]
0
0
Japan
Query!
State/province [266]
0
0
Ibaraki, Naka-gun
Query!
Country [267]
0
0
Japan
Query!
State/province [267]
0
0
Ishikawa, Kanazawa
Query!
Country [268]
0
0
Japan
Query!
State/province [268]
0
0
Iwate, Morioka
Query!
Country [269]
0
0
Japan
Query!
State/province [269]
0
0
Kagawa, Sakaide
Query!
Country [270]
0
0
Japan
Query!
State/province [270]
0
0
Kagawa, Takamatsu
Query!
Country [271]
0
0
Japan
Query!
State/province [271]
0
0
Kagoshima, Kagoshima
Query!
Country [272]
0
0
Japan
Query!
State/province [272]
0
0
Kanagawa, Isehara
Query!
Country [273]
0
0
Japan
Query!
State/province [273]
0
0
Kanagawa, Kawasaki
Query!
Country [274]
0
0
Japan
Query!
State/province [274]
0
0
Kanagawa, Sagamihara
Query!
Country [275]
0
0
Japan
Query!
State/province [275]
0
0
Kanagawa, Yokohama
Query!
Country [276]
0
0
Japan
Query!
State/province [276]
0
0
Kochi, Kochi
Query!
Country [277]
0
0
Japan
Query!
State/province [277]
0
0
Kochi, Nankoku
Query!
Country [278]
0
0
Japan
Query!
State/province [278]
0
0
Kyoto, Kyoto
Query!
Country [279]
0
0
Japan
Query!
State/province [279]
0
0
Mie, Matsusaka
Query!
Country [280]
0
0
Japan
Query!
State/province [280]
0
0
Miyagi, Sendai
Query!
Country [281]
0
0
Japan
Query!
State/province [281]
0
0
Nagano, Matsumoto
Query!
Country [282]
0
0
Japan
Query!
State/province [282]
0
0
Nagano, Matumoto
Query!
Country [283]
0
0
Japan
Query!
State/province [283]
0
0
Nagasaki, Isahaya
Query!
Country [284]
0
0
Japan
Query!
State/province [284]
0
0
Nara, Ikoma
Query!
Country [285]
0
0
Japan
Query!
State/province [285]
0
0
Niigata, Niigata
Query!
Country [286]
0
0
Japan
Query!
State/province [286]
0
0
Okayama, Okayama
Query!
Country [287]
0
0
Japan
Query!
State/province [287]
0
0
Okayama
Query!
Country [288]
0
0
Japan
Query!
State/province [288]
0
0
Okinawa, Urasoe
Query!
Country [289]
0
0
Japan
Query!
State/province [289]
0
0
Okinawa, Uruma
Query!
Country [290]
0
0
Japan
Query!
State/province [290]
0
0
Osaka, Ikeda
Query!
Country [291]
0
0
Japan
Query!
State/province [291]
0
0
Osaka, Kishiwada
Query!
Country [292]
0
0
Japan
Query!
State/province [292]
0
0
Osaka, Osakasayama
Query!
Country [293]
0
0
Japan
Query!
State/province [293]
0
0
Osaka, Osaka
Query!
Country [294]
0
0
Japan
Query!
State/province [294]
0
0
Osaka, Sakai
Query!
Country [295]
0
0
Japan
Query!
State/province [295]
0
0
Osaka, Takatsuki
Query!
Country [296]
0
0
Japan
Query!
State/province [296]
0
0
Osaka, Toyonaka
Query!
Country [297]
0
0
Japan
Query!
State/province [297]
0
0
Osaka, Yao
Query!
Country [298]
0
0
Japan
Query!
State/province [298]
0
0
Saitama, Koshigaya
Query!
Country [299]
0
0
Japan
Query!
State/province [299]
0
0
Saitama, Saitama
Query!
Country [300]
0
0
Japan
Query!
State/province [300]
0
0
Shiga
Query!
Country [301]
0
0
Japan
Query!
State/province [301]
0
0
Shimane, Izumo
Query!
Country [302]
0
0
Japan
Query!
State/province [302]
0
0
Shizuoka, Hamamatsu
Query!
Country [303]
0
0
Japan
Query!
State/province [303]
0
0
Shizuoka, Shizuoka
Query!
Country [304]
0
0
Japan
Query!
State/province [304]
0
0
Tochigi, Shimotsuke
Query!
Country [305]
0
0
Japan
Query!
State/province [305]
0
0
Tokyo, Chiyoda-ku
Query!
Country [306]
0
0
Japan
Query!
State/province [306]
0
0
Tokyo, Chuo-ku
Query!
Country [307]
0
0
Japan
Query!
State/province [307]
0
0
Tokyo, Hachioji
Query!
Country [308]
0
0
Japan
Query!
State/province [308]
0
0
Tokyo, Itabashi-ku
Query!
Country [309]
0
0
Japan
Query!
State/province [309]
0
0
Tokyo, Koto-ku
Query!
Country [310]
0
0
Japan
Query!
State/province [310]
0
0
Tokyo, Meguro-ku
Query!
Country [311]
0
0
Japan
Query!
State/province [311]
0
0
Tokyo, Minato-ku
Query!
Country [312]
0
0
Japan
Query!
State/province [312]
0
0
Tokyo, Shinagawa-ku
Query!
Country [313]
0
0
Japan
Query!
State/province [313]
0
0
Tokyo, Shinjuku-ku
Query!
Country [314]
0
0
Japan
Query!
State/province [314]
0
0
Tokyo, Tachikawa
Query!
Country [315]
0
0
Japan
Query!
State/province [315]
0
0
Tokyo, Toshima-ku
Query!
Country [316]
0
0
Japan
Query!
State/province [316]
0
0
Tokyo,
Query!
Country [317]
0
0
Japan
Query!
State/province [317]
0
0
Tokyo
Query!
Country [318]
0
0
Japan
Query!
State/province [318]
0
0
Wakayama, Hidaka-gun
Query!
Country [319]
0
0
Japan
Query!
State/province [319]
0
0
Wakayama, Wakayama
Query!
Country [320]
0
0
Japan
Query!
State/province [320]
0
0
Yamagata, Yonezawa
Query!
Country [321]
0
0
Japan
Query!
State/province [321]
0
0
Yamagata,
Query!
Country [322]
0
0
Japan
Query!
State/province [322]
0
0
Yamaguchi, Iwakuni
Query!
Country [323]
0
0
Japan
Query!
State/province [323]
0
0
Yamaguchi, Ube
Query!
Country [324]
0
0
Japan
Query!
State/province [324]
0
0
Yamanashi, Kofu
Query!
Country [325]
0
0
Korea, Republic of
Query!
State/province [325]
0
0
Bucheon
Query!
Country [326]
0
0
Korea, Republic of
Query!
State/province [326]
0
0
Goyang
Query!
Country [327]
0
0
Korea, Republic of
Query!
State/province [327]
0
0
Gwangju
Query!
Country [328]
0
0
Korea, Republic of
Query!
State/province [328]
0
0
Seoul
Query!
Country [329]
0
0
Korea, Republic of
Query!
State/province [329]
0
0
Wonju
Query!
Country [330]
0
0
Latvia
Query!
State/province [330]
0
0
Daugavpils
Query!
Country [331]
0
0
Latvia
Query!
State/province [331]
0
0
Riga
Query!
Country [332]
0
0
Latvia
Query!
State/province [332]
0
0
Tukums
Query!
Country [333]
0
0
Latvia
Query!
State/province [333]
0
0
Valmiera
Query!
Country [334]
0
0
Lithuania
Query!
State/province [334]
0
0
Kaunas
Query!
Country [335]
0
0
Lithuania
Query!
State/province [335]
0
0
Klaipeda
Query!
Country [336]
0
0
Lithuania
Query!
State/province [336]
0
0
Vilnius
Query!
Country [337]
0
0
Malaysia
Query!
State/province [337]
0
0
Kota Bahru
Query!
Country [338]
0
0
Malaysia
Query!
State/province [338]
0
0
Kuala Lumpur
Query!
Country [339]
0
0
Malaysia
Query!
State/province [339]
0
0
Kuala Terengganu
Query!
Country [340]
0
0
Malaysia
Query!
State/province [340]
0
0
Kuching
Query!
Country [341]
0
0
Mexico
Query!
State/province [341]
0
0
Aguascalientes
Query!
Country [342]
0
0
Mexico
Query!
State/province [342]
0
0
Guadalajara
Query!
Country [343]
0
0
Mexico
Query!
State/province [343]
0
0
León
Query!
Country [344]
0
0
Mexico
Query!
State/province [344]
0
0
Monterrey
Query!
Country [345]
0
0
Mexico
Query!
State/province [345]
0
0
México
Query!
Country [346]
0
0
Mexico
Query!
State/province [346]
0
0
Tijuana
Query!
Country [347]
0
0
Netherlands
Query!
State/province [347]
0
0
Alkmaar
Query!
Country [348]
0
0
Netherlands
Query!
State/province [348]
0
0
Almelo
Query!
Country [349]
0
0
Netherlands
Query!
State/province [349]
0
0
Amsterdam
Query!
Country [350]
0
0
Netherlands
Query!
State/province [350]
0
0
Assen
Query!
Country [351]
0
0
Netherlands
Query!
State/province [351]
0
0
Breda
Query!
Country [352]
0
0
Netherlands
Query!
State/province [352]
0
0
EDE
Query!
Country [353]
0
0
Netherlands
Query!
State/province [353]
0
0
Eindhoven
Query!
Country [354]
0
0
Netherlands
Query!
State/province [354]
0
0
Groningen
Query!
Country [355]
0
0
Netherlands
Query!
State/province [355]
0
0
Harderwijk
Query!
Country [356]
0
0
Netherlands
Query!
State/province [356]
0
0
Hoofddorp
Query!
Country [357]
0
0
Netherlands
Query!
State/province [357]
0
0
Hoorn
Query!
Country [358]
0
0
Netherlands
Query!
State/province [358]
0
0
Leeuwarden
Query!
Country [359]
0
0
Netherlands
Query!
State/province [359]
0
0
Leiden
Query!
Country [360]
0
0
Netherlands
Query!
State/province [360]
0
0
Rotterdam
Query!
Country [361]
0
0
Netherlands
Query!
State/province [361]
0
0
Sittard - Geleen
Query!
Country [362]
0
0
Netherlands
Query!
State/province [362]
0
0
Zutphen
Query!
Country [363]
0
0
New Zealand
Query!
State/province [363]
0
0
Auckland, New Zealand
Query!
Country [364]
0
0
New Zealand
Query!
State/province [364]
0
0
Christchurch Central
Query!
Country [365]
0
0
New Zealand
Query!
State/province [365]
0
0
Christchurch
Query!
Country [366]
0
0
New Zealand
Query!
State/province [366]
0
0
Dunedin
Query!
Country [367]
0
0
New Zealand
Query!
State/province [367]
0
0
Greenlane East Auckland NZ
Query!
Country [368]
0
0
New Zealand
Query!
State/province [368]
0
0
Hamilton
Query!
Country [369]
0
0
New Zealand
Query!
State/province [369]
0
0
Tauranga
Query!
Country [370]
0
0
Norway
Query!
State/province [370]
0
0
Arendal
Query!
Country [371]
0
0
Norway
Query!
State/province [371]
0
0
Hamar
Query!
Country [372]
0
0
Norway
Query!
State/province [372]
0
0
Hønefoss
Query!
Country [373]
0
0
Norway
Query!
State/province [373]
0
0
Kløfta
Query!
Country [374]
0
0
Norway
Query!
State/province [374]
0
0
Lierskogen
Query!
Country [375]
0
0
Norway
Query!
State/province [375]
0
0
Oslo
Query!
Country [376]
0
0
Norway
Query!
State/province [376]
0
0
Skedsmokorset
Query!
Country [377]
0
0
Philippines
Query!
State/province [377]
0
0
Angeles City
Query!
Country [378]
0
0
Philippines
Query!
State/province [378]
0
0
Cebu City
Query!
Country [379]
0
0
Philippines
Query!
State/province [379]
0
0
Dasmarinas
Query!
Country [380]
0
0
Philippines
Query!
State/province [380]
0
0
Davao City
Query!
Country [381]
0
0
Philippines
Query!
State/province [381]
0
0
Iloilo
Query!
Country [382]
0
0
Philippines
Query!
State/province [382]
0
0
Manila
Query!
Country [383]
0
0
Philippines
Query!
State/province [383]
0
0
Quezon City
Query!
Country [384]
0
0
Poland
Query!
State/province [384]
0
0
Bialystok
Query!
Country [385]
0
0
Poland
Query!
State/province [385]
0
0
Bydgoszcz
Query!
Country [386]
0
0
Poland
Query!
State/province [386]
0
0
Chojnice
Query!
Country [387]
0
0
Poland
Query!
State/province [387]
0
0
Katowice
Query!
Country [388]
0
0
Poland
Query!
State/province [388]
0
0
Kielce
Query!
Country [389]
0
0
Poland
Query!
State/province [389]
0
0
Krakow
Query!
Country [390]
0
0
Poland
Query!
State/province [390]
0
0
Libiaz
Query!
Country [391]
0
0
Poland
Query!
State/province [391]
0
0
Lodz
Query!
Country [392]
0
0
Poland
Query!
State/province [392]
0
0
Lublin
Query!
Country [393]
0
0
Poland
Query!
State/province [393]
0
0
Olsztyn
Query!
Country [394]
0
0
Poland
Query!
State/province [394]
0
0
Ostow Wielkopolski
Query!
Country [395]
0
0
Poland
Query!
State/province [395]
0
0
Ostroda
Query!
Country [396]
0
0
Poland
Query!
State/province [396]
0
0
Piaseczno
Query!
Country [397]
0
0
Poland
Query!
State/province [397]
0
0
Poznan
Query!
Country [398]
0
0
Poland
Query!
State/province [398]
0
0
Skierniewice
Query!
Country [399]
0
0
Poland
Query!
State/province [399]
0
0
Swidnik
Query!
Country [400]
0
0
Poland
Query!
State/province [400]
0
0
Szczecin
Query!
Country [401]
0
0
Poland
Query!
State/province [401]
0
0
Tarnobrzeg
Query!
Country [402]
0
0
Poland
Query!
State/province [402]
0
0
Warszawa
Query!
Country [403]
0
0
Poland
Query!
State/province [403]
0
0
Wolomin
Query!
Country [404]
0
0
Poland
Query!
State/province [404]
0
0
Wroclaw
Query!
Country [405]
0
0
Poland
Query!
State/province [405]
0
0
Zawadzkie
Query!
Country [406]
0
0
Poland
Query!
State/province [406]
0
0
Zgierz
Query!
Country [407]
0
0
Portugal
Query!
State/province [407]
0
0
Almada
Query!
Country [408]
0
0
Portugal
Query!
State/province [408]
0
0
Amadora
Query!
Country [409]
0
0
Portugal
Query!
State/province [409]
0
0
Aveiro
Query!
Country [410]
0
0
Portugal
Query!
State/province [410]
0
0
Braga
Query!
Country [411]
0
0
Portugal
Query!
State/province [411]
0
0
Coimbra
Query!
Country [412]
0
0
Portugal
Query!
State/province [412]
0
0
Guimarães
Query!
Country [413]
0
0
Portugal
Query!
State/province [413]
0
0
Lisboa
Query!
Country [414]
0
0
Portugal
Query!
State/province [414]
0
0
Porto
Query!
Country [415]
0
0
Portugal
Query!
State/province [415]
0
0
Vila Nova de Gaia
Query!
Country [416]
0
0
Romania
Query!
State/province [416]
0
0
Bragadiru
Query!
Country [417]
0
0
Romania
Query!
State/province [417]
0
0
Bucharest
Query!
Country [418]
0
0
Romania
Query!
State/province [418]
0
0
Constanta
Query!
Country [419]
0
0
Romania
Query!
State/province [419]
0
0
Timisoara
Query!
Country [420]
0
0
Russian Federation
Query!
State/province [420]
0
0
Arkhangelsk
Query!
Country [421]
0
0
Russian Federation
Query!
State/province [421]
0
0
Barnaul
Query!
Country [422]
0
0
Russian Federation
Query!
State/province [422]
0
0
Chelyabinsk
Query!
Country [423]
0
0
Russian Federation
Query!
State/province [423]
0
0
Ekaterinburg
Query!
Country [424]
0
0
Russian Federation
Query!
State/province [424]
0
0
Gatchina
Query!
Country [425]
0
0
Russian Federation
Query!
State/province [425]
0
0
Ivanovo
Query!
Country [426]
0
0
Russian Federation
Query!
State/province [426]
0
0
Kazan
Query!
Country [427]
0
0
Russian Federation
Query!
State/province [427]
0
0
Kemerovo
Query!
Country [428]
0
0
Russian Federation
Query!
State/province [428]
0
0
Kirov
Query!
Country [429]
0
0
Russian Federation
Query!
State/province [429]
0
0
Lomonosov
Query!
Country [430]
0
0
Russian Federation
Query!
State/province [430]
0
0
Moscow
Query!
Country [431]
0
0
Russian Federation
Query!
State/province [431]
0
0
Novosibirsk
Query!
Country [432]
0
0
Russian Federation
Query!
State/province [432]
0
0
Omsk
Query!
Country [433]
0
0
Russian Federation
Query!
State/province [433]
0
0
Penza
Query!
Country [434]
0
0
Russian Federation
Query!
State/province [434]
0
0
Pskov
Query!
Country [435]
0
0
Russian Federation
Query!
State/province [435]
0
0
Rosto-on-Don
Query!
Country [436]
0
0
Russian Federation
Query!
State/province [436]
0
0
Rostov-na-Donu
Query!
Country [437]
0
0
Russian Federation
Query!
State/province [437]
0
0
Saratov
Query!
Country [438]
0
0
Russian Federation
Query!
State/province [438]
0
0
St. Petersburg
Query!
Country [439]
0
0
Russian Federation
Query!
State/province [439]
0
0
Tomsk
Query!
Country [440]
0
0
Russian Federation
Query!
State/province [440]
0
0
Ulyanovsk
Query!
Country [441]
0
0
Russian Federation
Query!
State/province [441]
0
0
Volgograd
Query!
Country [442]
0
0
Russian Federation
Query!
State/province [442]
0
0
Yaroslavl
Query!
Country [443]
0
0
Serbia
Query!
State/province [443]
0
0
Belgrade
Query!
Country [444]
0
0
Serbia
Query!
State/province [444]
0
0
Kragujevac
Query!
Country [445]
0
0
Serbia
Query!
State/province [445]
0
0
Nis
Query!
Country [446]
0
0
Serbia
Query!
State/province [446]
0
0
Sombor
Query!
Country [447]
0
0
Serbia
Query!
State/province [447]
0
0
Sremska Kamenica
Query!
Country [448]
0
0
Singapore
Query!
State/province [448]
0
0
Singapore
Query!
Country [449]
0
0
Slovakia
Query!
State/province [449]
0
0
Bratislava
Query!
Country [450]
0
0
Slovakia
Query!
State/province [450]
0
0
Humenne
Query!
Country [451]
0
0
Slovakia
Query!
State/province [451]
0
0
Kosice
Query!
Country [452]
0
0
Slovakia
Query!
State/province [452]
0
0
Martin
Query!
Country [453]
0
0
Slovakia
Query!
State/province [453]
0
0
Poprad
Query!
Country [454]
0
0
Slovakia
Query!
State/province [454]
0
0
Spisska Nova Ves
Query!
Country [455]
0
0
Slovakia
Query!
State/province [455]
0
0
Vrable
Query!
Country [456]
0
0
Slovenia
Query!
State/province [456]
0
0
Golnik
Query!
Country [457]
0
0
Slovenia
Query!
State/province [457]
0
0
Pohorje
Query!
Country [458]
0
0
Slovenia
Query!
State/province [458]
0
0
Topolsica
Query!
Country [459]
0
0
South Africa
Query!
State/province [459]
0
0
Amanzimtoti
Query!
Country [460]
0
0
South Africa
Query!
State/province [460]
0
0
Cape Town
Query!
Country [461]
0
0
South Africa
Query!
State/province [461]
0
0
Morningside, Sandton
Query!
Country [462]
0
0
South Africa
Query!
State/province [462]
0
0
Parow
Query!
Country [463]
0
0
South Africa
Query!
State/province [463]
0
0
Pretoria
Query!
Country [464]
0
0
Spain
Query!
State/province [464]
0
0
Alicante
Query!
Country [465]
0
0
Spain
Query!
State/province [465]
0
0
Aranjuez
Query!
Country [466]
0
0
Spain
Query!
State/province [466]
0
0
Badalona
Query!
Country [467]
0
0
Spain
Query!
State/province [467]
0
0
Barakaldo (Bilbao)
Query!
Country [468]
0
0
Spain
Query!
State/province [468]
0
0
Barcelona
Query!
Country [469]
0
0
Spain
Query!
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Funding & Sponsors
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Name
Boehringer Ingelheim
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Summary
Brief summary
The overall objective is to assess the effect of once daily tiotropium + olodaterol fixed dose combination compared to 5 µg tiotropium (both delivered with the Respimat® inhaler) on moderate to severe COPD exacerbation in patients with severe to very severe COPD.
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Trial website
https://clinicaltrials.gov/study/NCT02296138
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Trial related presentations / publications
Singh D, Wedzicha JA, Siddiqui S, de la Hoz A, Xue W, Magnussen H, Miravitlles M, Chalmers JD, Calverley PMA. Blood eosinophils as a biomarker of future COPD exacerbation risk: pooled data from 11 clinical trials. Respir Res. 2020 Sep 17;21(1):240. doi: 10.1186/s12931-020-01482-1. Wedzicha JA, Buhl R, Singh D, Vogelmeier CF, de la Hoz A, Xue W, Anzueto A, Calverley PMA. Tiotropium/Olodaterol Decreases Exacerbation Rates Compared with Tiotropium in a Range of Patients with COPD: Pooled Analysis of the TONADO(R)/DYNAGITO(R) Trials. Adv Ther. 2020 Oct;37(10):4266-4279. doi: 10.1007/s12325-020-01438-3. Epub 2020 Aug 10. Ferguson GT, Buhl R, Bothner U, Hoz A, Voss F, Anzueto A, Calverley PMA. Safety of tiotropium/olodaterol in chronic obstructive pulmonary disease: pooled analysis of three large, 52-week, randomized clinical trials. Respir Med. 2018 Oct;143:67-73. doi: 10.1016/j.rmed.2018.08.012. Epub 2018 Aug 28. Calverley PMA, Anzueto AR, Carter K, Gronke L, Hallmann C, Jenkins C, Wedzicha J, Rabe KF. Tiotropium and olodaterol in the prevention of chronic obstructive pulmonary disease exacerbations (DYNAGITO): a double-blind, randomised, parallel-group, active-controlled trial. Lancet Respir Med. 2018 May;6(5):337-344. doi: 10.1016/S2213-2600(18)30102-4. Epub 2018 Apr 5.
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Public notes
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Contacts
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Boehringer Ingelheim
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Boehringer Ingelheim
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Attachment
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/38/NCT02296138/SAP_000.pdf
Study protocol
https://cdn.clinicaltrials.gov/large-docs/38/NCT02296138/Prot_001.pdf
Results publications and other study-related documents
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Results not provided in
https://clinicaltrials.gov/study/NCT02296138
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