Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00387088
Registration number
NCT00387088
Ethics application status
Date submitted
11/10/2006
Date registered
12/10/2006
Date last updated
16/05/2014
Titles & IDs
Public title
Tiotropium / Respimat One Year Study in COPD.
Query!
Scientific title
Efficacy {FEV1, COPD Exacerbations & HRQoL} & Safety of 5mcg Tiotropium Respimat in COPD
Query!
Secondary ID [1]
0
0
2006-001009-27
Query!
Secondary ID [2]
0
0
205.372
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Pulmonary Disease, Chronic Obstructive
0
0
Query!
Condition category
Condition code
Respiratory
0
0
0
0
Query!
Chronic obstructive pulmonary disease
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Devices - Respimat
Treatment: Drugs - Tiotropium
Other: Tiotropium - Tiotropium 5µg via Respimat® inhaler (2 inhalations of 2.5µg per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
Other: Placebo - Placebo via Respimat® inhaler (2 inhalations per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
Treatment: Devices: Respimat
Treatment: Drugs: Tiotropium
Query!
Intervention code [1]
0
0
Treatment: Devices
Query!
Intervention code [2]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Day 337
Query!
Assessment method [1]
0
0
Trough FEV1 is defined as the FEV1 measured at the -10 min time point at the end of the dosing interval (24 h post drug administration).
Query!
Timepoint [1]
0
0
Baseline and Day 337
Query!
Primary outcome [2]
0
0
Time to First Chronic Obstructive Pulmonary Disease (COPD) Exacerbation
Query!
Assessment method [2]
0
0
Time to first COPD exacerbation (defined as a complex of respiratory events/symptoms (increase or new onset) with a duration of 3 days or more requiring a change in treatment). Time is days from start of study treatment to onset of exacerbation.
Query!
Timepoint [2]
0
0
During actual study treatment period (planned Day 1 to Day 337)
Query!
Secondary outcome [1]
0
0
Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Day 29
Query!
Assessment method [1]
0
0
Trough FEV1 is the mean volume of air that can be forced out in one second after taking a deep breath approximately 24 hours after the last administration of study drug.
Query!
Timepoint [1]
0
0
Baseline and Day 29
Query!
Secondary outcome [2]
0
0
Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Day 169
Query!
Assessment method [2]
0
0
Trough FEV1 is the mean volume of air that can be forced out in one second after taking a deep breath approximately 24 hours after the last administration of study drug.
Query!
Timepoint [2]
0
0
Baseline and Day 169
Query!
Secondary outcome [3]
0
0
Number of COPD Exacerbations Per Patient - Exposure Adjusted
Query!
Assessment method [3]
0
0
Number of COPD exacerbations (defined as a complex of respiratory events/symptoms (increase or new onset) with a duration of 3 days or more requiring a change in treatment) per patient adjusted by length of treatment exposure (i.e. number of exacerbations multiplied by 365.25 and then divided by days of treatment exposure)
Query!
Timepoint [3]
0
0
During actual study treatment period (planned Day 1 to Day 337)
Query!
Secondary outcome [4]
0
0
Number of COPD Exacerbations Per Patient - naïve Estimate
Query!
Assessment method [4]
0
0
Number of COPD exacerbations (defined as a complex of respiratory events/symptoms (increase or new onset) with a duration of 3 days or more requiring a change in treatment) per patient not adjusted for treatment exposure (i.e. naïve estimate)
Query!
Timepoint [4]
0
0
During actual study treatment period (planned Day 1 to Day 337)
Query!
Secondary outcome [5]
0
0
Number of Patients With at Least One COPD Exacerbation
Query!
Assessment method [5]
0
0
Number of patients with at least one COPD exacerbation (defined as a complex of respiratory events/symptoms (increase or new onset) with a duration of 3 days or more requiring a change in treatment)
Query!
Timepoint [5]
0
0
During actual study treatment period (planned Day 1 to Day 337)
Query!
Secondary outcome [6]
0
0
Time to First Hospitalisation for COPD Exacerbation
Query!
Assessment method [6]
0
0
Time to first hospitalisation for COPD exacerbation (a complex of respiratory events/symptoms (increase or new onset) with a duration of 3 days or more requiring a change in treatment). Time is days from start of study treatment to onset of exacerbation
Query!
Timepoint [6]
0
0
During actual study treatment period (planned Day 1 to Day 337)
Query!
Secondary outcome [7]
0
0
Number of Hospitalisations for COPD Exacerbations Per Patient - Exposure Adjusted
Query!
Assessment method [7]
0
0
Number of hospitalisations for COPD exacerbations (a complex of respiratory events/symptoms (increase or new onset) with a duration of 3 days or more requiring a change in treatment) per patient adjusted by length of treatment exposure (i.e. no. of exacerbations multiplied by 365.25 and then divided by days of treatment exposure)
Query!
Timepoint [7]
0
0
During actual study treatment period (planned Day 1 to Day 337)
Query!
Secondary outcome [8]
0
0
Number of Hospitalisations for COPD Exacerbations Per Patient - naïve Estimate
Query!
Assessment method [8]
0
0
Number of hospitalisations for COPD exacerbations (a complex of respiratory events/symptoms (increase or new onset) with a duration of 3 days or more requiring a change in treatment) per patient not adjusted for treatment exposure (i.e. naïve estimate)
Query!
Timepoint [8]
0
0
During actual study treatment period (planned Day 1 to Day 337)
Query!
Secondary outcome [9]
0
0
Number of Patients With at Least One Hospitalisation for a COPD Exacerbation
Query!
Assessment method [9]
0
0
Number of patients with at least one hospitalisation for a COPD exacerbation (a complex of respiratory events/symptoms (increase or new onset) with a duration of 3 days or more requiring a change in treatment)
Query!
Timepoint [9]
0
0
During actual study treatment period (planned Day 1 to Day 337)
Query!
Secondary outcome [10]
0
0
Change From Baseline in Saint George's Respiratory Questionnaire (SGRQ) Total Score at Day 337
Query!
Assessment method [10]
0
0
The SGRQ total score measures quality of life on a continuous scale ranging from 0=best state to 100=worst state
Query!
Timepoint [10]
0
0
Baseline and Day 337
Query!
Secondary outcome [11]
0
0
Change From Baseline in Saint George's Respiratory Questionnaire (SGRQ) Total Score at Day 169
Query!
Assessment method [11]
0
0
The SGRQ total score measures quality of life on a continuous scale ranging from 0=best state to 100=worst state
Query!
Timepoint [11]
0
0
Baseline and Day 169
Query!
Secondary outcome [12]
0
0
Change From Baseline in Saint George's Respiratory Questionnaire (SGRQ) Domain Score at Day 337
Query!
Assessment method [12]
0
0
The SGRQ domain score (symptom, activity and impact) measures quality of life on a continuous scale ranging from 0=best state to 100=worst state
Query!
Timepoint [12]
0
0
Baseline and Day 337
Query!
Secondary outcome [13]
0
0
Change From Baseline in Saint George's Respiratory Questionnaire (SGRQ) Domain Score at Day 169
Query!
Assessment method [13]
0
0
The SGRQ domain score (symptom, activity and impact) measures quality of life on a continuous scale ranging from 0=best state to 100=worst state
Query!
Timepoint [13]
0
0
Baseline and Day 169
Query!
Secondary outcome [14]
0
0
Change From Baseline in Trough Forced Vital Capacity (FVC) at Day 29
Query!
Assessment method [14]
0
0
Trough FVC is the mean maximum volume of air that can be forcibly expired from the lungs; measured approximately 24 hours after the last administration of study drug.
Query!
Timepoint [14]
0
0
Baseline and Day 29
Query!
Secondary outcome [15]
0
0
Change From Baseline in Trough Forced Vital Capacity (FVC) at Day 169
Query!
Assessment method [15]
0
0
Trough FVC is the mean maximum volume of air that can be forcibly expired from the lungs; measured approximately 24 hours after the last administration of study drug.
Query!
Timepoint [15]
0
0
Baseline and Day 169
Query!
Secondary outcome [16]
0
0
Change From Baseline in Trough Forced Vital Capacity (FVC) at Day 337
Query!
Assessment method [16]
0
0
Trough FVC is the mean maximum volume of air that can be forcibly expired from the lungs; measured approximately 24 hours after the last administration of study drug.
Query!
Timepoint [16]
0
0
Baseline and Day 337
Query!
Secondary outcome [17]
0
0
Marked Changes From Baseline in Vital Signs at End of Treatment
Query!
Assessment method [17]
0
0
Marked changes from baseline in vital signs (diastolic and systolic blood pressure (DBP and SBP) and pulse rate (PR)) at end of treatment.
SBP - Increase means SBP >150 mmHg and an increase above baseline of >25 mmHg. SBP - Decrease means SBP <100 mmHg and a decrease below baseline of >10 mmHg.
DBP - Increase means DBP >90 mmHg and an increase above baseline of >10 mmHg. DBP - Decrease means DBP <60 mmHg and a decrease below baseline of >10 mmHg.
PR - Increase means PR >100 bpm and an increase above baseline of >10 bpm. PR - Decrease means PR <60 bpm and a decrease below baseline of >10 bpm.
Query!
Timepoint [17]
0
0
Baseline and end of treatment
Query!
Secondary outcome [18]
0
0
Clinically Relevant Findings in Physical Examination and ECG
Query!
Assessment method [18]
0
0
Clinically relevant findings in Physical Examination and ECG at end of treatment
Query!
Timepoint [18]
0
0
End of treatment
Query!
Eligibility
Key inclusion criteria
1. Male or female
2. At least 40 years old
3. Smoker or ex-smoker
4. Smoking history > 10 pack-years
5. Forced Expiratory Volume in 1 Second (FEV1) < 60% predicted
Query!
Minimum age
40
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
1. Recent history of myocardial infarction, life-threatening cardiac arrhythmia or
hospitalisation for cardiac failure
2. History of asthma or allergic conditions.
3. Malignancy requiring treatment within past 5 years
4. Life-threatening pulmonary obstruction, cystic fibrosis or clinically evident
bronchiectasis
5. Known active tuberculosis
6. Known hypersensitivity to anticholinergic drugs.
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
1/09/2006
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
3991
Query!
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Query!
Recruitment hospital [1]
0
0
205.372.61002 Woolcock Institute of Medical Research - Glebe
Query!
Recruitment hospital [2]
0
0
205.372.61009 Thoracic & General Physician - Cairns
Query!
Recruitment hospital [3]
0
0
205.372.61005 Redcliffe Hospital - Redcliffe
Query!
Recruitment hospital [4]
0
0
205.372.61006 The Investigator Clinic - Port Lincoln
Query!
Recruitment hospital [5]
0
0
205.372.61007 The Burnside War Memorial Hospital - Toorak Gardens
Query!
Recruitment hospital [6]
0
0
205.372.61004 Boehringer Ingelheim Investigational Site - Woodville
Query!
Recruitment hospital [7]
0
0
205.372.61010 Ecru - Box Hill
Query!
Recruitment hospital [8]
0
0
205.372.61008 Geelong Clinical Research Centre - Geelong
Query!
Recruitment hospital [9]
0
0
205.372.61001 Emeritus Research - Malvern
Query!
Recruitment hospital [10]
0
0
205.372.61003 Sir Charles Gairdner Hospital - Nedlands
Query!
Recruitment postcode(s) [1]
0
0
- Glebe
Query!
Recruitment postcode(s) [2]
0
0
- Cairns
Query!
Recruitment postcode(s) [3]
0
0
- Redcliffe
Query!
Recruitment postcode(s) [4]
0
0
- Port Lincoln
Query!
Recruitment postcode(s) [5]
0
0
- Toorak Gardens
Query!
Recruitment postcode(s) [6]
0
0
- Woodville
Query!
Recruitment postcode(s) [7]
0
0
- Box Hill
Query!
Recruitment postcode(s) [8]
0
0
- Geelong
Query!
Recruitment postcode(s) [9]
0
0
- Malvern
Query!
Recruitment postcode(s) [10]
0
0
- Nedlands
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Alabama
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
California
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Colorado
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Connecticut
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Florida
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Georgia
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Illinois
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Iowa
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Kansas
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Louisiana
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
Maine
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
Maryland
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
Michigan
Query!
Country [14]
0
0
United States of America
Query!
State/province [14]
0
0
Minnesota
Query!
Country [15]
0
0
United States of America
Query!
State/province [15]
0
0
Missouri
Query!
Country [16]
0
0
United States of America
Query!
State/province [16]
0
0
Nebraska
Query!
Country [17]
0
0
United States of America
Query!
State/province [17]
0
0
New Mexico
Query!
Country [18]
0
0
United States of America
Query!
State/province [18]
0
0
New York
Query!
Country [19]
0
0
United States of America
Query!
State/province [19]
0
0
North Carolina
Query!
Country [20]
0
0
United States of America
Query!
State/province [20]
0
0
Ohio
Query!
Country [21]
0
0
United States of America
Query!
State/province [21]
0
0
Oklahoma
Query!
Country [22]
0
0
United States of America
Query!
State/province [22]
0
0
Oregon
Query!
Country [23]
0
0
United States of America
Query!
State/province [23]
0
0
Pennsylvania
Query!
Country [24]
0
0
United States of America
Query!
State/province [24]
0
0
Texas
Query!
Country [25]
0
0
United States of America
Query!
State/province [25]
0
0
Virginia
Query!
Country [26]
0
0
United States of America
Query!
State/province [26]
0
0
Washington
Query!
Country [27]
0
0
Brazil
Query!
State/province [27]
0
0
Florianópolis
Query!
Country [28]
0
0
Brazil
Query!
State/province [28]
0
0
Goiânia
Query!
Country [29]
0
0
Brazil
Query!
State/province [29]
0
0
Recife
Query!
Country [30]
0
0
Brazil
Query!
State/province [30]
0
0
São Paulo - SP
Query!
Country [31]
0
0
Brazil
Query!
State/province [31]
0
0
Vitória
Query!
Country [32]
0
0
Canada
Query!
State/province [32]
0
0
Alberta
Query!
Country [33]
0
0
Canada
Query!
State/province [33]
0
0
British Columbia
Query!
Country [34]
0
0
Canada
Query!
State/province [34]
0
0
New Brunswick
Query!
Country [35]
0
0
Canada
Query!
State/province [35]
0
0
Newfoundland and Labrador
Query!
Country [36]
0
0
Canada
Query!
State/province [36]
0
0
Ontario
Query!
Country [37]
0
0
Canada
Query!
State/province [37]
0
0
Quebec
Query!
Country [38]
0
0
Canada
Query!
State/province [38]
0
0
Saskatchewan
Query!
Country [39]
0
0
China
Query!
State/province [39]
0
0
Beijing
Query!
Country [40]
0
0
China
Query!
State/province [40]
0
0
Chengdu, Sichuan Province
Query!
Country [41]
0
0
China
Query!
State/province [41]
0
0
Chongqing
Query!
Country [42]
0
0
China
Query!
State/province [42]
0
0
Guangzhou
Query!
Country [43]
0
0
China
Query!
State/province [43]
0
0
Shanghai
Query!
Country [44]
0
0
China
Query!
State/province [44]
0
0
Shenyang
Query!
Country [45]
0
0
China
Query!
State/province [45]
0
0
Wuhan
Query!
Country [46]
0
0
Denmark
Query!
State/province [46]
0
0
Aarhus C
Query!
Country [47]
0
0
Denmark
Query!
State/province [47]
0
0
Horsens
Query!
Country [48]
0
0
Denmark
Query!
State/province [48]
0
0
Hvidovre
Query!
Country [49]
0
0
Denmark
Query!
State/province [49]
0
0
København NV
Query!
Country [50]
0
0
Denmark
Query!
State/province [50]
0
0
Odense C
Query!
Country [51]
0
0
Denmark
Query!
State/province [51]
0
0
Silkeborg
Query!
Country [52]
0
0
Finland
Query!
State/province [52]
0
0
Helsinki
Query!
Country [53]
0
0
Finland
Query!
State/province [53]
0
0
Jyväskylä
Query!
Country [54]
0
0
Finland
Query!
State/province [54]
0
0
Lahti
Query!
Country [55]
0
0
Finland
Query!
State/province [55]
0
0
Tampere
Query!
Country [56]
0
0
France
Query!
State/province [56]
0
0
Castelnau le Lez
Query!
Country [57]
0
0
France
Query!
State/province [57]
0
0
Chamalières
Query!
Country [58]
0
0
France
Query!
State/province [58]
0
0
Clermont Ferrand cedex 1
Query!
Country [59]
0
0
France
Query!
State/province [59]
0
0
Denain
Query!
Country [60]
0
0
France
Query!
State/province [60]
0
0
Grasse
Query!
Country [61]
0
0
France
Query!
State/province [61]
0
0
Marseille
Query!
Country [62]
0
0
France
Query!
State/province [62]
0
0
Metz cedex 1
Query!
Country [63]
0
0
France
Query!
State/province [63]
0
0
Montigny les Metz
Query!
Country [64]
0
0
France
Query!
State/province [64]
0
0
Nantes
Query!
Country [65]
0
0
France
Query!
State/province [65]
0
0
Nice
Query!
Country [66]
0
0
France
Query!
State/province [66]
0
0
Nimes cedex 9
Query!
Country [67]
0
0
France
Query!
State/province [67]
0
0
Nîmes
Query!
Country [68]
0
0
France
Query!
State/province [68]
0
0
Ollioules
Query!
Country [69]
0
0
France
Query!
State/province [69]
0
0
Reims
Query!
Country [70]
0
0
France
Query!
State/province [70]
0
0
Saint Laurent du Var
Query!
Country [71]
0
0
France
Query!
State/province [71]
0
0
Six Four les Plages
Query!
Country [72]
0
0
France
Query!
State/province [72]
0
0
St Gaudens
Query!
Country [73]
0
0
France
Query!
State/province [73]
0
0
Toulon
Query!
Country [74]
0
0
France
Query!
State/province [74]
0
0
Toulouse
Query!
Country [75]
0
0
Germany
Query!
State/province [75]
0
0
Berlin
Query!
Country [76]
0
0
Germany
Query!
State/province [76]
0
0
Bonn
Query!
Country [77]
0
0
Germany
Query!
State/province [77]
0
0
Bruchsal
Query!
Country [78]
0
0
Germany
Query!
State/province [78]
0
0
Frankfurt/Main
Query!
Country [79]
0
0
Germany
Query!
State/province [79]
0
0
Gelnhausen
Query!
Country [80]
0
0
Germany
Query!
State/province [80]
0
0
Gütersloh
Query!
Country [81]
0
0
Germany
Query!
State/province [81]
0
0
Hannover
Query!
Country [82]
0
0
Germany
Query!
State/province [82]
0
0
Kassel
Query!
Country [83]
0
0
Germany
Query!
State/province [83]
0
0
Minden
Query!
Country [84]
0
0
Germany
Query!
State/province [84]
0
0
München
Query!
Country [85]
0
0
Germany
Query!
State/province [85]
0
0
Weinheim
Query!
Country [86]
0
0
Germany
Query!
State/province [86]
0
0
Weyhe
Query!
Country [87]
0
0
Germany
Query!
State/province [87]
0
0
Wiesloch
Query!
Country [88]
0
0
Germany
Query!
State/province [88]
0
0
Witten
Query!
Country [89]
0
0
Greece
Query!
State/province [89]
0
0
Athens
Query!
Country [90]
0
0
Greece
Query!
State/province [90]
0
0
Heraklion-Crete
Query!
Country [91]
0
0
Greece
Query!
State/province [91]
0
0
Kalamaria
Query!
Country [92]
0
0
Greece
Query!
State/province [92]
0
0
Kavala
Query!
Country [93]
0
0
Greece
Query!
State/province [93]
0
0
Komotini
Query!
Country [94]
0
0
Greece
Query!
State/province [94]
0
0
Korinthos
Query!
Country [95]
0
0
Greece
Query!
State/province [95]
0
0
Nafplio
Query!
Country [96]
0
0
Greece
Query!
State/province [96]
0
0
Serres
Query!
Country [97]
0
0
Greece
Query!
State/province [97]
0
0
Thessaloniki
Query!
Country [98]
0
0
Greece
Query!
State/province [98]
0
0
Thiva
Query!
Country [99]
0
0
Hong Kong
Query!
State/province [99]
0
0
Hong Kong
Query!
Country [100]
0
0
Hong Kong
Query!
State/province [100]
0
0
Kowloon
Query!
Country [101]
0
0
Hungary
Query!
State/province [101]
0
0
Budapest
Query!
Country [102]
0
0
Hungary
Query!
State/province [102]
0
0
Debrecen
Query!
Country [103]
0
0
Hungary
Query!
State/province [103]
0
0
Deszk
Query!
Country [104]
0
0
Hungary
Query!
State/province [104]
0
0
Erd
Query!
Country [105]
0
0
Hungary
Query!
State/province [105]
0
0
Mosonmagyarovar
Query!
Country [106]
0
0
Hungary
Query!
State/province [106]
0
0
Sopron
Query!
Country [107]
0
0
India
Query!
State/province [107]
0
0
Andhra Pradesh
Query!
Country [108]
0
0
India
Query!
State/province [108]
0
0
Bangalore
Query!
Country [109]
0
0
India
Query!
State/province [109]
0
0
Calicut,Kerala
Query!
Country [110]
0
0
India
Query!
State/province [110]
0
0
Chennai
Query!
Country [111]
0
0
India
Query!
State/province [111]
0
0
Coimbatore
Query!
Country [112]
0
0
India
Query!
State/province [112]
0
0
Gujarat
Query!
Country [113]
0
0
India
Query!
State/province [113]
0
0
indore,MP
Query!
Country [114]
0
0
India
Query!
State/province [114]
0
0
Maharashtra
Query!
Country [115]
0
0
India
Query!
State/province [115]
0
0
Mumbai
Query!
Country [116]
0
0
India
Query!
State/province [116]
0
0
New Delhi
Query!
Country [117]
0
0
India
Query!
State/province [117]
0
0
Punjab
Query!
Country [118]
0
0
India
Query!
State/province [118]
0
0
Tamil Nadu
Query!
Country [119]
0
0
India
Query!
State/province [119]
0
0
Uttar Pradesh
Query!
Country [120]
0
0
Ireland
Query!
State/province [120]
0
0
Mullingar
Query!
Country [121]
0
0
Italy
Query!
State/province [121]
0
0
Bussolengo (vr)
Query!
Country [122]
0
0
Italy
Query!
State/province [122]
0
0
Ferrara
Query!
Country [123]
0
0
Italy
Query!
State/province [123]
0
0
Genova
Query!
Country [124]
0
0
Italy
Query!
State/province [124]
0
0
Milano
Query!
Country [125]
0
0
Italy
Query!
State/province [125]
0
0
Modena
Query!
Country [126]
0
0
Italy
Query!
State/province [126]
0
0
Orbassano (to)
Query!
Country [127]
0
0
Italy
Query!
State/province [127]
0
0
Pisa
Query!
Country [128]
0
0
Italy
Query!
State/province [128]
0
0
Pordenone
Query!
Country [129]
0
0
Italy
Query!
State/province [129]
0
0
Prato (fi)
Query!
Country [130]
0
0
Italy
Query!
State/province [130]
0
0
Roma
Query!
Country [131]
0
0
Italy
Query!
State/province [131]
0
0
Trieste
Query!
Country [132]
0
0
Korea, Republic of
Query!
State/province [132]
0
0
Anyang
Query!
Country [133]
0
0
Korea, Republic of
Query!
State/province [133]
0
0
Daegu
Query!
Country [134]
0
0
Korea, Republic of
Query!
State/province [134]
0
0
Daejoen
Query!
Country [135]
0
0
Korea, Republic of
Query!
State/province [135]
0
0
Incheon
Query!
Country [136]
0
0
Korea, Republic of
Query!
State/province [136]
0
0
Jeonbuk
Query!
Country [137]
0
0
Korea, Republic of
Query!
State/province [137]
0
0
Kwangju
Query!
Country [138]
0
0
Korea, Republic of
Query!
State/province [138]
0
0
Pusan
Query!
Country [139]
0
0
Korea, Republic of
Query!
State/province [139]
0
0
Seoul
Query!
Country [140]
0
0
Lithuania
Query!
State/province [140]
0
0
Kaunas
Query!
Country [141]
0
0
Lithuania
Query!
State/province [141]
0
0
Vilnius
Query!
Country [142]
0
0
Malaysia
Query!
State/province [142]
0
0
Johor Baharu
Query!
Country [143]
0
0
Malaysia
Query!
State/province [143]
0
0
Kelantan Darul Naim
Query!
Country [144]
0
0
Malaysia
Query!
State/province [144]
0
0
Kuala Lumpur
Query!
Country [145]
0
0
Malaysia
Query!
State/province [145]
0
0
Kuching, Sarawak
Query!
Country [146]
0
0
Malaysia
Query!
State/province [146]
0
0
Penang
Query!
Country [147]
0
0
Malaysia
Query!
State/province [147]
0
0
Selangor
Query!
Country [148]
0
0
Mexico
Query!
State/province [148]
0
0
Chihuahua
Query!
Country [149]
0
0
Mexico
Query!
State/province [149]
0
0
Col. Seccion XVI
Query!
Country [150]
0
0
Mexico
Query!
State/province [150]
0
0
Cuernavaca, Mor. México
Query!
Country [151]
0
0
Mexico
Query!
State/province [151]
0
0
Guadalajara Jal.
Query!
Country [152]
0
0
Mexico
Query!
State/province [152]
0
0
Guadalajara
Query!
Country [153]
0
0
Mexico
Query!
State/province [153]
0
0
Hermosillo, Sonora
Query!
Country [154]
0
0
Mexico
Query!
State/province [154]
0
0
Huixquilucan Edo.Mex.
Query!
Country [155]
0
0
Mexico
Query!
State/province [155]
0
0
Merida Yuc.
Query!
Country [156]
0
0
Mexico
Query!
State/province [156]
0
0
Mexicali Baja California Norte
Query!
Country [157]
0
0
Mexico
Query!
State/province [157]
0
0
Monterrey, Nuevo León
Query!
Country [158]
0
0
Mexico
Query!
State/province [158]
0
0
Mérida Yucatán
Query!
Country [159]
0
0
Mexico
Query!
State/province [159]
0
0
San Luis Potosi
Query!
Country [160]
0
0
Mexico
Query!
State/province [160]
0
0
Zapopan, Jal.
Query!
Country [161]
0
0
Netherlands
Query!
State/province [161]
0
0
Amsterdam
Query!
Country [162]
0
0
Netherlands
Query!
State/province [162]
0
0
Drachten
Query!
Country [163]
0
0
Netherlands
Query!
State/province [163]
0
0
Groningen
Query!
Country [164]
0
0
Netherlands
Query!
State/province [164]
0
0
Hoofddorp
Query!
Country [165]
0
0
Netherlands
Query!
State/province [165]
0
0
Leeuwarden
Query!
Country [166]
0
0
Netherlands
Query!
State/province [166]
0
0
Roosendaal
Query!
Country [167]
0
0
Netherlands
Query!
State/province [167]
0
0
Sneek
Query!
Country [168]
0
0
Netherlands
Query!
State/province [168]
0
0
Utrecht
Query!
Country [169]
0
0
Netherlands
Query!
State/province [169]
0
0
Voorburg
Query!
Country [170]
0
0
Netherlands
Query!
State/province [170]
0
0
Weerselo
Query!
Country [171]
0
0
Netherlands
Query!
State/province [171]
0
0
Winschoten
Query!
Country [172]
0
0
Norway
Query!
State/province [172]
0
0
Sandvika
Query!
Country [173]
0
0
Norway
Query!
State/province [173]
0
0
Trondheim
Query!
Country [174]
0
0
Norway
Query!
State/province [174]
0
0
Ålesund
Query!
Country [175]
0
0
Portugal
Query!
State/province [175]
0
0
Amadora
Query!
Country [176]
0
0
Portugal
Query!
State/province [176]
0
0
Lisboa
Query!
Country [177]
0
0
Portugal
Query!
State/province [177]
0
0
Porto
Query!
Country [178]
0
0
Portugal
Query!
State/province [178]
0
0
Viana do Castelo
Query!
Country [179]
0
0
Singapore
Query!
State/province [179]
0
0
Singapore
Query!
Country [180]
0
0
Slovakia
Query!
State/province [180]
0
0
Bratislava
Query!
Country [181]
0
0
Slovakia
Query!
State/province [181]
0
0
Nove Zamky
Query!
Country [182]
0
0
South Africa
Query!
State/province [182]
0
0
Bellville
Query!
Country [183]
0
0
South Africa
Query!
State/province [183]
0
0
Cape Town
Query!
Country [184]
0
0
South Africa
Query!
State/province [184]
0
0
Centurion
Query!
Country [185]
0
0
South Africa
Query!
State/province [185]
0
0
Durban
Query!
Country [186]
0
0
South Africa
Query!
State/province [186]
0
0
Pretoria
Query!
Country [187]
0
0
South Africa
Query!
State/province [187]
0
0
Somerset West
Query!
Country [188]
0
0
Spain
Query!
State/province [188]
0
0
Cáceres
Query!
Country [189]
0
0
Spain
Query!
State/province [189]
0
0
Madrid
Query!
Country [190]
0
0
Spain
Query!
State/province [190]
0
0
Terrassa (Barcelona)
Query!
Country [191]
0
0
Spain
Query!
State/province [191]
0
0
Valencia
Query!
Country [192]
0
0
Sweden
Query!
State/province [192]
0
0
Boden
Query!
Country [193]
0
0
Sweden
Query!
State/province [193]
0
0
Höllviken
Query!
Country [194]
0
0
Sweden
Query!
State/province [194]
0
0
Linköping
Query!
Country [195]
0
0
Sweden
Query!
State/province [195]
0
0
Stockholm
Query!
Country [196]
0
0
Sweden
Query!
State/province [196]
0
0
Sundsvall
Query!
Country [197]
0
0
Switzerland
Query!
State/province [197]
0
0
Lugano
Query!
Country [198]
0
0
Switzerland
Query!
State/province [198]
0
0
Montana
Query!
Country [199]
0
0
Switzerland
Query!
State/province [199]
0
0
Zürich
Query!
Country [200]
0
0
Taiwan
Query!
State/province [200]
0
0
Kaohsiung
Query!
Country [201]
0
0
Taiwan
Query!
State/province [201]
0
0
Tainan
Query!
Country [202]
0
0
Taiwan
Query!
State/province [202]
0
0
Taipei
Query!
Country [203]
0
0
Taiwan
Query!
State/province [203]
0
0
Taoyuan
Query!
Country [204]
0
0
Turkey
Query!
State/province [204]
0
0
Ankara
Query!
Country [205]
0
0
Turkey
Query!
State/province [205]
0
0
Bursa
Query!
Country [206]
0
0
Turkey
Query!
State/province [206]
0
0
Edirne
Query!
Country [207]
0
0
Turkey
Query!
State/province [207]
0
0
Istanbul
Query!
Country [208]
0
0
Turkey
Query!
State/province [208]
0
0
Izmir
Query!
Country [209]
0
0
Turkey
Query!
State/province [209]
0
0
Kayseri
Query!
Country [210]
0
0
Turkey
Query!
State/province [210]
0
0
Konya
Query!
Country [211]
0
0
Turkey
Query!
State/province [211]
0
0
Samsun
Query!
Country [212]
0
0
United Kingdom
Query!
State/province [212]
0
0
Aston Clinton, Aylesbury
Query!
Country [213]
0
0
United Kingdom
Query!
State/province [213]
0
0
Carmarthen
Query!
Country [214]
0
0
United Kingdom
Query!
State/province [214]
0
0
Chertsey
Query!
Country [215]
0
0
United Kingdom
Query!
State/province [215]
0
0
Chesterfield
Query!
Country [216]
0
0
United Kingdom
Query!
State/province [216]
0
0
Darlington
Query!
Country [217]
0
0
United Kingdom
Query!
State/province [217]
0
0
East Horsley
Query!
Country [218]
0
0
United Kingdom
Query!
State/province [218]
0
0
Fowey
Query!
Country [219]
0
0
United Kingdom
Query!
State/province [219]
0
0
Frome
Query!
Country [220]
0
0
United Kingdom
Query!
State/province [220]
0
0
Greenisland
Query!
Country [221]
0
0
United Kingdom
Query!
State/province [221]
0
0
Heywood
Query!
Country [222]
0
0
United Kingdom
Query!
State/province [222]
0
0
Isleworth
Query!
Country [223]
0
0
United Kingdom
Query!
State/province [223]
0
0
Kirkby in Ashfield
Query!
Country [224]
0
0
United Kingdom
Query!
State/province [224]
0
0
Mortimer
Query!
Country [225]
0
0
United Kingdom
Query!
State/province [225]
0
0
Nottingham
Query!
Country [226]
0
0
United Kingdom
Query!
State/province [226]
0
0
Penzance
Query!
Country [227]
0
0
United Kingdom
Query!
State/province [227]
0
0
Plymouth
Query!
Country [228]
0
0
United Kingdom
Query!
State/province [228]
0
0
Sheffield
Query!
Country [229]
0
0
United Kingdom
Query!
State/province [229]
0
0
Sneinton, Nottingham
Query!
Country [230]
0
0
United Kingdom
Query!
State/province [230]
0
0
St Just, Penzance
Query!
Country [231]
0
0
United Kingdom
Query!
State/province [231]
0
0
St. Austell
Query!
Country [232]
0
0
United Kingdom
Query!
State/province [232]
0
0
Sunderland
Query!
Country [233]
0
0
United Kingdom
Query!
State/province [233]
0
0
Wellingborough
Query!
Country [234]
0
0
United Kingdom
Query!
State/province [234]
0
0
Westbury on Trym
Query!
Country [235]
0
0
United Kingdom
Query!
State/province [235]
0
0
Windsor
Query!
Country [236]
0
0
United Kingdom
Query!
State/province [236]
0
0
Woking
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Query!
Name
Boehringer Ingelheim
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
The objective of the study is to evaluate the long-term (one year) efficacy and safety of
tiotropium delivered by the Respimat inhaler in patients with COPD. Specifically, the study
will examine the effect of treatment on COPD exacerbations.
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT00387088
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Boehringer Ingelheim
Query!
Address
0
0
Boehringer Ingelheim
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00387088
Download to PDF