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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/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.
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]
Secondary ID [1] 0 0
2014-002275-28
Secondary ID [2] 0 0
1237.19
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pulmonary Disease, Chronic Obstructive 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Chronic obstructive pulmonary disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - olodaterol
Treatment: Drugs - tiotropium
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

Treatment: Drugs: tiotropium
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Annualised Rate of Moderate to Severe COPD Exacerbations During the Actual Treatment Period.
Timepoint [1] 0 0
From first in-take of study medication until 1 day after last in-take of study medication, up to 361 days
Secondary outcome [1] 0 0
Number of Patients With at Least One Moderate to Severe COPD Exacerbation During the Actual Treatment Period.
Timepoint [1] 0 0
From first in-take of study medication until 1 day after last in-take of study medication, up to 361 days
Secondary outcome [2] 0 0
Annualised Rate of Exacerbations Leading to Hospitalisation During the Actual Treatment Period.
Timepoint [2] 0 0
From first in-take of study medication until 1 day after last in-take of study medication, up to 361 days
Secondary outcome [3] 0 0
Number of Patients With at Least One COPD Exacerbation Leading to Hospitalisation During the Actual Treatment Period.
Timepoint [3] 0 0
From first in-take of study medication until 1 day after last in-take of study medication, up to 361 days
Secondary outcome [4] 0 0
Number of Patients With All-cause Mortality Occurring During the Actual Treatment Period.
Timepoint [4] 0 0
From first in-take of study medication until 1 day after last in-take of study medication, up to 361 days

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.
Minimum age
40 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
13/01/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
29/03/2017
Sample size
Target
Accrual to date
Final
7903
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
1237.19.61012 Boehringer Ingelheim Investigational Site - Campbelltown
Recruitment hospital [2] 0 0
1237.19.61011 Boehringer Ingelheim Investigational Site - Kogarah
Recruitment hospital [3] 0 0
1237.19.61008 Boehringer Ingelheim Investigational Site - Randwick
Recruitment hospital [4] 0 0
1237.19.61010 Boehringer Ingelheim Investigational Site - Cairns
Recruitment hospital [5] 0 0
1237.19.61006 Boehringer Ingelheim Investigational Site - Chermside
Recruitment hospital [6] 0 0
1237.19.61001 Boehringer Ingelheim Investigational Site - Daw Park
Recruitment hospital [7] 0 0
1237.19.61002 Boehringer Ingelheim Investigational Site - Kent Town
Recruitment hospital [8] 0 0
1237.19.61007 Boehringer Ingelheim Investigational Site - Woodville
Recruitment hospital [9] 0 0
1237.19.61013 Boehringer Ingelheim Investigational Site - Box Hill
Recruitment hospital [10] 0 0
1237.19.61003 Boehringer Ingelheim Investigational Site - Melbourne
Recruitment hospital [11] 0 0
1237.19.61009 Boehringer Ingelheim Investigational Site - Parkville
Recruitment hospital [12] 0 0
1237.19.61004 Boehringer Ingelheim Investigational Site - Murdoch
Recruitment postcode(s) [1] 0 0
- Campbelltown
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- Kogarah
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- Randwick
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- Cairns
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- Chermside
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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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- Murdoch
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Country [204] 0 0
India
State/province [204] 0 0
Ludhiana
Country [205] 0 0
India
State/province [205] 0 0
Madurai
Country [206] 0 0
India
State/province [206] 0 0
Mysore
Country [207] 0 0
India
State/province [207] 0 0
Nagpur
Country [208] 0 0
India
State/province [208] 0 0
New Delhi
Country [209] 0 0
India
State/province [209] 0 0
Panjim
Country [210] 0 0
India
State/province [210] 0 0
Pune
Country [211] 0 0
India
State/province [211] 0 0
Vellore
Country [212] 0 0
India
State/province [212] 0 0
Vishakhapatnam
Country [213] 0 0
Ireland
State/province [213] 0 0
Dublin 24
Country [214] 0 0
Ireland
State/province [214] 0 0
Wilton
Country [215] 0 0
Italy
State/province [215] 0 0
Cittadella (PD)
Country [216] 0 0
Italy
State/province [216] 0 0
Ferrara
Country [217] 0 0
Italy
State/province [217] 0 0
Messina
Country [218] 0 0
Italy
State/province [218] 0 0
Milano
Country [219] 0 0
Italy
State/province [219] 0 0
Monza
Country [220] 0 0
Italy
State/province [220] 0 0
Padova
Country [221] 0 0
Italy
State/province [221] 0 0
Palermo
Country [222] 0 0
Italy
State/province [222] 0 0
Parma
Country [223] 0 0
Italy
State/province [223] 0 0
Pavia
Country [224] 0 0
Italy
State/province [224] 0 0
Perugia
Country [225] 0 0
Italy
State/province [225] 0 0
Piacenza
Country [226] 0 0
Italy
State/province [226] 0 0
Pisa
Country [227] 0 0
Italy
State/province [227] 0 0
Pordenone
Country [228] 0 0
Italy
State/province [228] 0 0
Roma
Country [229] 0 0
Italy
State/province [229] 0 0
San Pietro Vernotico (BR)
Country [230] 0 0
Italy
State/province [230] 0 0
Sassari
Country [231] 0 0
Italy
State/province [231] 0 0
Scafati (SA)
Country [232] 0 0
Japan
State/province [232] 0 0
Aichi, Komaki
Country [233] 0 0
Japan
State/province [233] 0 0
Aichi, Nagoya
Country [234] 0 0
Japan
State/province [234] 0 0
Aichi, Obu
Country [235] 0 0
Japan
State/province [235] 0 0
Aichi, Seto
Country [236] 0 0
Japan
State/province [236] 0 0
Chiba, Chiba
Country [237] 0 0
Japan
State/province [237] 0 0
Chiba, Kamogawa
Country [238] 0 0
Japan
State/province [238] 0 0
Fukui, Fukui
Country [239] 0 0
Japan
State/province [239] 0 0
Fukuoka, Fukuoka
Country [240] 0 0
Japan
State/province [240] 0 0
Fukuoka, Kitakyushu-city
Country [241] 0 0
Japan
State/province [241] 0 0
Fukuoka, Koga
Country [242] 0 0
Japan
State/province [242] 0 0
Fukuoka, Kurume
Country [243] 0 0
Japan
State/province [243] 0 0
Fukuoka, Yanagawa
Country [244] 0 0
Japan
State/province [244] 0 0
Fukuoka, Yukuhashi
Country [245] 0 0
Japan
State/province [245] 0 0
Fukushima, Fukushima
Country [246] 0 0
Japan
State/province [246] 0 0
Gifu, Mizunami
Country [247] 0 0
Japan
State/province [247] 0 0
Gifu, Ogaki
Country [248] 0 0
Japan
State/province [248] 0 0
Gunma, Fujioka
Country [249] 0 0
Japan
State/province [249] 0 0
Gunma, Maebashi
Country [250] 0 0
Japan
State/province [250] 0 0
Gunma, Takasaki
Country [251] 0 0
Japan
State/province [251] 0 0
Hiroshima, Fukuyama
Country [252] 0 0
Japan
State/province [252] 0 0
Hiroshima, Hiroshima
Country [253] 0 0
Japan
State/province [253] 0 0
Hiroshima, Kure
Country [254] 0 0
Japan
State/province [254] 0 0
Hokkaido, Asahikawa
Country [255] 0 0
Japan
State/province [255] 0 0
Hokkaido, Chitose
Country [256] 0 0
Japan
State/province [256] 0 0
Hokkaido, Hakodate
Country [257] 0 0
Japan
State/province [257] 0 0
Hokkaido, Obihiro
Country [258] 0 0
Japan
State/province [258] 0 0
Hokkaido, Otaru
Country [259] 0 0
Japan
State/province [259] 0 0
Hokkaido, Sapporo
Country [260] 0 0
Japan
State/province [260] 0 0
Hokkaido, Tomakomai
Country [261] 0 0
Japan
State/province [261] 0 0
Hyogo, Himeji
Country [262] 0 0
Japan
State/province [262] 0 0
Hyogo, Kobe
Country [263] 0 0
Japan
State/province [263] 0 0
Hyogo, Nishinomiya
Country [264] 0 0
Japan
State/province [264] 0 0
Ibaraki, Hitachinaka
Country [265] 0 0
Japan
State/province [265] 0 0
Ibaraki, Inashiki-gun
Country [266] 0 0
Japan
State/province [266] 0 0
Ibaraki, Naka-gun
Country [267] 0 0
Japan
State/province [267] 0 0
Ishikawa, Kanazawa
Country [268] 0 0
Japan
State/province [268] 0 0
Iwate, Morioka
Country [269] 0 0
Japan
State/province [269] 0 0
Kagawa, Sakaide
Country [270] 0 0
Japan
State/province [270] 0 0
Kagawa, Takamatsu
Country [271] 0 0
Japan
State/province [271] 0 0
Kagoshima, Kagoshima
Country [272] 0 0
Japan
State/province [272] 0 0
Kanagawa, Isehara
Country [273] 0 0
Japan
State/province [273] 0 0
Kanagawa, Kawasaki
Country [274] 0 0
Japan
State/province [274] 0 0
Kanagawa, Sagamihara
Country [275] 0 0
Japan
State/province [275] 0 0
Kanagawa, Yokohama
Country [276] 0 0
Japan
State/province [276] 0 0
Kochi, Kochi
Country [277] 0 0
Japan
State/province [277] 0 0
Kochi, Nankoku
Country [278] 0 0
Japan
State/province [278] 0 0
Kyoto, Kyoto
Country [279] 0 0
Japan
State/province [279] 0 0
Mie, Matsusaka
Country [280] 0 0
Japan
State/province [280] 0 0
Miyagi, Sendai
Country [281] 0 0
Japan
State/province [281] 0 0
Nagano, Matsumoto
Country [282] 0 0
Japan
State/province [282] 0 0
Nagano, Matumoto
Country [283] 0 0
Japan
State/province [283] 0 0
Nagasaki, Isahaya
Country [284] 0 0
Japan
State/province [284] 0 0
Nara, Ikoma
Country [285] 0 0
Japan
State/province [285] 0 0
Niigata, Niigata
Country [286] 0 0
Japan
State/province [286] 0 0
Okayama, Okayama
Country [287] 0 0
Japan
State/province [287] 0 0
Okayama
Country [288] 0 0
Japan
State/province [288] 0 0
Okinawa, Urasoe
Country [289] 0 0
Japan
State/province [289] 0 0
Okinawa, Uruma
Country [290] 0 0
Japan
State/province [290] 0 0
Osaka, Ikeda
Country [291] 0 0
Japan
State/province [291] 0 0
Osaka, Kishiwada
Country [292] 0 0
Japan
State/province [292] 0 0
Osaka, Osakasayama
Country [293] 0 0
Japan
State/province [293] 0 0
Osaka, Osaka
Country [294] 0 0
Japan
State/province [294] 0 0
Osaka, Sakai
Country [295] 0 0
Japan
State/province [295] 0 0
Osaka, Takatsuki
Country [296] 0 0
Japan
State/province [296] 0 0
Osaka, Toyonaka
Country [297] 0 0
Japan
State/province [297] 0 0
Osaka, Yao
Country [298] 0 0
Japan
State/province [298] 0 0
Saitama, Koshigaya
Country [299] 0 0
Japan
State/province [299] 0 0
Saitama, Saitama
Country [300] 0 0
Japan
State/province [300] 0 0
Shiga
Country [301] 0 0
Japan
State/province [301] 0 0
Shimane, Izumo
Country [302] 0 0
Japan
State/province [302] 0 0
Shizuoka, Hamamatsu
Country [303] 0 0
Japan
State/province [303] 0 0
Shizuoka, Shizuoka
Country [304] 0 0
Japan
State/province [304] 0 0
Tochigi, Shimotsuke
Country [305] 0 0
Japan
State/province [305] 0 0
Tokyo, Chiyoda-ku
Country [306] 0 0
Japan
State/province [306] 0 0
Tokyo, Chuo-ku
Country [307] 0 0
Japan
State/province [307] 0 0
Tokyo, Hachioji
Country [308] 0 0
Japan
State/province [308] 0 0
Tokyo, Itabashi-ku
Country [309] 0 0
Japan
State/province [309] 0 0
Tokyo, Koto-ku
Country [310] 0 0
Japan
State/province [310] 0 0
Tokyo, Meguro-ku
Country [311] 0 0
Japan
State/province [311] 0 0
Tokyo, Minato-ku
Country [312] 0 0
Japan
State/province [312] 0 0
Tokyo, Shinagawa-ku
Country [313] 0 0
Japan
State/province [313] 0 0
Tokyo, Shinjuku-ku
Country [314] 0 0
Japan
State/province [314] 0 0
Tokyo, Tachikawa
Country [315] 0 0
Japan
State/province [315] 0 0
Tokyo, Toshima-ku
Country [316] 0 0
Japan
State/province [316] 0 0
Tokyo,
Country [317] 0 0
Japan
State/province [317] 0 0
Tokyo
Country [318] 0 0
Japan
State/province [318] 0 0
Wakayama, Hidaka-gun
Country [319] 0 0
Japan
State/province [319] 0 0
Wakayama, Wakayama
Country [320] 0 0
Japan
State/province [320] 0 0
Yamagata, Yonezawa
Country [321] 0 0
Japan
State/province [321] 0 0
Yamagata,
Country [322] 0 0
Japan
State/province [322] 0 0
Yamaguchi, Iwakuni
Country [323] 0 0
Japan
State/province [323] 0 0
Yamaguchi, Ube
Country [324] 0 0
Japan
State/province [324] 0 0
Yamanashi, Kofu
Country [325] 0 0
Korea, Republic of
State/province [325] 0 0
Bucheon
Country [326] 0 0
Korea, Republic of
State/province [326] 0 0
Goyang
Country [327] 0 0
Korea, Republic of
State/province [327] 0 0
Gwangju
Country [328] 0 0
Korea, Republic of
State/province [328] 0 0
Seoul
Country [329] 0 0
Korea, Republic of
State/province [329] 0 0
Wonju
Country [330] 0 0
Latvia
State/province [330] 0 0
Daugavpils
Country [331] 0 0
Latvia
State/province [331] 0 0
Riga
Country [332] 0 0
Latvia
State/province [332] 0 0
Tukums
Country [333] 0 0
Latvia
State/province [333] 0 0
Valmiera
Country [334] 0 0
Lithuania
State/province [334] 0 0
Kaunas
Country [335] 0 0
Lithuania
State/province [335] 0 0
Klaipeda
Country [336] 0 0
Lithuania
State/province [336] 0 0
Vilnius
Country [337] 0 0
Malaysia
State/province [337] 0 0
Kota Bahru
Country [338] 0 0
Malaysia
State/province [338] 0 0
Kuala Lumpur
Country [339] 0 0
Malaysia
State/province [339] 0 0
Kuala Terengganu
Country [340] 0 0
Malaysia
State/province [340] 0 0
Kuching
Country [341] 0 0
Mexico
State/province [341] 0 0
Aguascalientes
Country [342] 0 0
Mexico
State/province [342] 0 0
Guadalajara
Country [343] 0 0
Mexico
State/province [343] 0 0
León
Country [344] 0 0
Mexico
State/province [344] 0 0
Monterrey
Country [345] 0 0
Mexico
State/province [345] 0 0
México
Country [346] 0 0
Mexico
State/province [346] 0 0
Tijuana
Country [347] 0 0
Netherlands
State/province [347] 0 0
Alkmaar
Country [348] 0 0
Netherlands
State/province [348] 0 0
Almelo
Country [349] 0 0
Netherlands
State/province [349] 0 0
Amsterdam
Country [350] 0 0
Netherlands
State/province [350] 0 0
Assen
Country [351] 0 0
Netherlands
State/province [351] 0 0
Breda
Country [352] 0 0
Netherlands
State/province [352] 0 0
EDE
Country [353] 0 0
Netherlands
State/province [353] 0 0
Eindhoven
Country [354] 0 0
Netherlands
State/province [354] 0 0
Groningen
Country [355] 0 0
Netherlands
State/province [355] 0 0
Harderwijk
Country [356] 0 0
Netherlands
State/province [356] 0 0
Hoofddorp
Country [357] 0 0
Netherlands
State/province [357] 0 0
Hoorn
Country [358] 0 0
Netherlands
State/province [358] 0 0
Leeuwarden
Country [359] 0 0
Netherlands
State/province [359] 0 0
Leiden
Country [360] 0 0
Netherlands
State/province [360] 0 0
Rotterdam
Country [361] 0 0
Netherlands
State/province [361] 0 0
Sittard - Geleen
Country [362] 0 0
Netherlands
State/province [362] 0 0
Zutphen
Country [363] 0 0
New Zealand
State/province [363] 0 0
Auckland, New Zealand
Country [364] 0 0
New Zealand
State/province [364] 0 0
Christchurch Central
Country [365] 0 0
New Zealand
State/province [365] 0 0
Christchurch
Country [366] 0 0
New Zealand
State/province [366] 0 0
Dunedin
Country [367] 0 0
New Zealand
State/province [367] 0 0
Greenlane East Auckland NZ
Country [368] 0 0
New Zealand
State/province [368] 0 0
Hamilton
Country [369] 0 0
New Zealand
State/province [369] 0 0
Tauranga
Country [370] 0 0
Norway
State/province [370] 0 0
Arendal
Country [371] 0 0
Norway
State/province [371] 0 0
Hamar
Country [372] 0 0
Norway
State/province [372] 0 0
Hønefoss
Country [373] 0 0
Norway
State/province [373] 0 0
Kløfta
Country [374] 0 0
Norway
State/province [374] 0 0
Lierskogen
Country [375] 0 0
Norway
State/province [375] 0 0
Oslo
Country [376] 0 0
Norway
State/province [376] 0 0
Skedsmokorset
Country [377] 0 0
Philippines
State/province [377] 0 0
Angeles City
Country [378] 0 0
Philippines
State/province [378] 0 0
Cebu City
Country [379] 0 0
Philippines
State/province [379] 0 0
Dasmarinas
Country [380] 0 0
Philippines
State/province [380] 0 0
Davao City
Country [381] 0 0
Philippines
State/province [381] 0 0
Iloilo
Country [382] 0 0
Philippines
State/province [382] 0 0
Manila
Country [383] 0 0
Philippines
State/province [383] 0 0
Quezon City
Country [384] 0 0
Poland
State/province [384] 0 0
Bialystok
Country [385] 0 0
Poland
State/province [385] 0 0
Bydgoszcz
Country [386] 0 0
Poland
State/province [386] 0 0
Chojnice
Country [387] 0 0
Poland
State/province [387] 0 0
Katowice
Country [388] 0 0
Poland
State/province [388] 0 0
Kielce
Country [389] 0 0
Poland
State/province [389] 0 0
Krakow
Country [390] 0 0
Poland
State/province [390] 0 0
Libiaz
Country [391] 0 0
Poland
State/province [391] 0 0
Lodz
Country [392] 0 0
Poland
State/province [392] 0 0
Lublin
Country [393] 0 0
Poland
State/province [393] 0 0
Olsztyn
Country [394] 0 0
Poland
State/province [394] 0 0
Ostow Wielkopolski
Country [395] 0 0
Poland
State/province [395] 0 0
Ostroda
Country [396] 0 0
Poland
State/province [396] 0 0
Piaseczno
Country [397] 0 0
Poland
State/province [397] 0 0
Poznan
Country [398] 0 0
Poland
State/province [398] 0 0
Skierniewice
Country [399] 0 0
Poland
State/province [399] 0 0
Swidnik
Country [400] 0 0
Poland
State/province [400] 0 0
Szczecin
Country [401] 0 0
Poland
State/province [401] 0 0
Tarnobrzeg
Country [402] 0 0
Poland
State/province [402] 0 0
Warszawa
Country [403] 0 0
Poland
State/province [403] 0 0
Wolomin
Country [404] 0 0
Poland
State/province [404] 0 0
Wroclaw
Country [405] 0 0
Poland
State/province [405] 0 0
Zawadzkie
Country [406] 0 0
Poland
State/province [406] 0 0
Zgierz
Country [407] 0 0
Portugal
State/province [407] 0 0
Almada
Country [408] 0 0
Portugal
State/province [408] 0 0
Amadora
Country [409] 0 0
Portugal
State/province [409] 0 0
Aveiro
Country [410] 0 0
Portugal
State/province [410] 0 0
Braga
Country [411] 0 0
Portugal
State/province [411] 0 0
Coimbra
Country [412] 0 0
Portugal
State/province [412] 0 0
Guimarães
Country [413] 0 0
Portugal
State/province [413] 0 0
Lisboa
Country [414] 0 0
Portugal
State/province [414] 0 0
Porto
Country [415] 0 0
Portugal
State/province [415] 0 0
Vila Nova de Gaia
Country [416] 0 0
Romania
State/province [416] 0 0
Bragadiru
Country [417] 0 0
Romania
State/province [417] 0 0
Bucharest
Country [418] 0 0
Romania
State/province [418] 0 0
Constanta
Country [419] 0 0
Romania
State/province [419] 0 0
Timisoara
Country [420] 0 0
Russian Federation
State/province [420] 0 0
Arkhangelsk
Country [421] 0 0
Russian Federation
State/province [421] 0 0
Barnaul
Country [422] 0 0
Russian Federation
State/province [422] 0 0
Chelyabinsk
Country [423] 0 0
Russian Federation
State/province [423] 0 0
Ekaterinburg
Country [424] 0 0
Russian Federation
State/province [424] 0 0
Gatchina
Country [425] 0 0
Russian Federation
State/province [425] 0 0
Ivanovo
Country [426] 0 0
Russian Federation
State/province [426] 0 0
Kazan
Country [427] 0 0
Russian Federation
State/province [427] 0 0
Kemerovo
Country [428] 0 0
Russian Federation
State/province [428] 0 0
Kirov
Country [429] 0 0
Russian Federation
State/province [429] 0 0
Lomonosov
Country [430] 0 0
Russian Federation
State/province [430] 0 0
Moscow
Country [431] 0 0
Russian Federation
State/province [431] 0 0
Novosibirsk
Country [432] 0 0
Russian Federation
State/province [432] 0 0
Omsk
Country [433] 0 0
Russian Federation
State/province [433] 0 0
Penza
Country [434] 0 0
Russian Federation
State/province [434] 0 0
Pskov
Country [435] 0 0
Russian Federation
State/province [435] 0 0
Rosto-on-Don
Country [436] 0 0
Russian Federation
State/province [436] 0 0
Rostov-na-Donu
Country [437] 0 0
Russian Federation
State/province [437] 0 0
Saratov
Country [438] 0 0
Russian Federation
State/province [438] 0 0
St. Petersburg
Country [439] 0 0
Russian Federation
State/province [439] 0 0
Tomsk
Country [440] 0 0
Russian Federation
State/province [440] 0 0
Ulyanovsk
Country [441] 0 0
Russian Federation
State/province [441] 0 0
Volgograd
Country [442] 0 0
Russian Federation
State/province [442] 0 0
Yaroslavl
Country [443] 0 0
Serbia
State/province [443] 0 0
Belgrade
Country [444] 0 0
Serbia
State/province [444] 0 0
Kragujevac
Country [445] 0 0
Serbia
State/province [445] 0 0
Nis
Country [446] 0 0
Serbia
State/province [446] 0 0
Sombor
Country [447] 0 0
Serbia
State/province [447] 0 0
Sremska Kamenica
Country [448] 0 0
Singapore
State/province [448] 0 0
Singapore
Country [449] 0 0
Slovakia
State/province [449] 0 0
Bratislava
Country [450] 0 0
Slovakia
State/province [450] 0 0
Humenne
Country [451] 0 0
Slovakia
State/province [451] 0 0
Kosice
Country [452] 0 0
Slovakia
State/province [452] 0 0
Martin
Country [453] 0 0
Slovakia
State/province [453] 0 0
Poprad
Country [454] 0 0
Slovakia
State/province [454] 0 0
Spisska Nova Ves
Country [455] 0 0
Slovakia
State/province [455] 0 0
Vrable
Country [456] 0 0
Slovenia
State/province [456] 0 0
Golnik
Country [457] 0 0
Slovenia
State/province [457] 0 0
Pohorje
Country [458] 0 0
Slovenia
State/province [458] 0 0
Topolsica
Country [459] 0 0
South Africa
State/province [459] 0 0
Amanzimtoti
Country [460] 0 0
South Africa
State/province [460] 0 0
Cape Town
Country [461] 0 0
South Africa
State/province [461] 0 0
Morningside, Sandton
Country [462] 0 0
South Africa
State/province [462] 0 0
Parow
Country [463] 0 0
South Africa
State/province [463] 0 0
Pretoria
Country [464] 0 0
Spain
State/province [464] 0 0
Alicante
Country [465] 0 0
Spain
State/province [465] 0 0
Aranjuez
Country [466] 0 0
Spain
State/province [466] 0 0
Badalona
Country [467] 0 0
Spain
State/province [467] 0 0
Barakaldo (Bilbao)
Country [468] 0 0
Spain
State/province [468] 0 0
Barcelona
Country [469] 0 0
Spain
State/province [469] 0 0
Centelles
Country [470] 0 0
Spain
State/province [470] 0 0
Cáceres
Country [471] 0 0
Spain
State/province [471] 0 0
Girona
Country [472] 0 0
Spain
State/province [472] 0 0
Granollers (Barcelona)
Country [473] 0 0
Spain
State/province [473] 0 0
L'Hospitalet Llobregat (bcn)
Country [474] 0 0
Spain
State/province [474] 0 0
Liencres (Pielagos)
Country [475] 0 0
Spain
State/province [475] 0 0
Madrid
Country [476] 0 0
Spain
State/province [476] 0 0
Malaga
Country [477] 0 0
Spain
State/province [477] 0 0
Mérida
Country [478] 0 0
Spain
State/province [478] 0 0
Palma de Mallorca
Country [479] 0 0
Spain
State/province [479] 0 0
Pamplona
Country [480] 0 0
Spain
State/province [480] 0 0
Pozuelo de Alarcón
Country [481] 0 0
Spain
State/province [481] 0 0
Sabadell
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Boehringer Ingelheim
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT02296138
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Boehringer Ingelheim
Address 0 0
Boehringer Ingelheim
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT02296138