Tiotropium +Olodaterol Fixed Dose Combination (FDC) Versus Tiotropium and Olodaterol in Chronic Obstructive Pulmonary Disease (COPD)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01431287
First received: September 8, 2011
Last updated: March 28, 2014
Last verified: March 2014
  Purpose

The overall objective of this study is to assess the efficacy and safety of 52 weeks once daily treatment with orally inhaled tiotropium + olodaterol FDC (delivered by the RESPIMAT Inhaler) compared with the individual components (tiotropium, olodaterol) (delivered by the RESPIMAT Inhaler) in patients with COPD.


Condition Intervention Phase
Pulmonary Disease, Chronic Obstructive
Drug: tiotropium + olodaterol
Drug: tiotropium
Drug: olodaterol
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Randomised, Double-blind, Parallel Group Study to Assess the Efficacy and Safety of 52 Weeks of Once Daily Treatment of Orally Inhaled Tiotropium + Olodaterol Fixed Dose Combination (2.5 µg / 5 µg; 5 µg / 5 µg) (Delivered by the Respimat® Inhaler) Compared With the Individual Components (2.5 µg and 5 µg Tiotropium, 5 µg Olodaterol) (Delivered by the Respimat® Inhaler) in Patients With Chronic Obstructive Pulmonary Disease (COPD) [TOnado TM 2]

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • FEV1 AUC0-3h response [L] on Day 169 [ Time Frame: 24 weeks treatment ] [ Designated as safety issue: No ]
  • Trough FEV1 response [L] on Day 170 [ Time Frame: 24 weeks treatment ] [ Designated as safety issue: No ]
  • SGRQ total score on Day 169 (This endpoint will be evaluated after combining the data from this and the replicate study 1237.5) [ Time Frame: 24 weeks treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • TDI focal score on Day 169 (Key secondary endpoint; This endpoint will be evaluated after combining the data from this and the replicate study 1237.5) [ Time Frame: 24 weeks treatment ] [ Designated as safety issue: No ]
  • FEV1 AUC0-3h response [L] on Day 1, Day 85 and Day 365 [ Time Frame: 52 weeks treatment ] [ Designated as safety issue: No ]
  • Trough FEV1 response [L] on Day 15, Day 43, Day 85, Day 169 and Day 365 [ Time Frame: 52 weeks treatment ] [ Designated as safety issue: No ]
  • FEV1 AUC0-12h response [L] in sub-set of patients with 12-hour PFTs on Day 169 (This endpoint will be evaluated after combining the data from this and the replicate study 1237.5) [ Time Frame: 24 weeks treatment ] [ Designated as safety issue: No ]
  • FVC AUC0-12h response [L] in sub-set of patients with 12-hour PFTs on Day 169 (This endpoint will be evaluated after combining the data from this and the replicate study 1237.5) [ Time Frame: 24 weeks treatment ] [ Designated as safety issue: No ]
  • FEV1 AUC0-24h response [L] in sub-set of patients with 12-hour PFTs on Day 169 (This endpoint will be evaluated after combining the data from this and the replicate study 1237.5) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • FVC AUC0-3h response [L] on Day 1, Day 85 and Day 365 [ Time Frame: 52 weeks treatment ] [ Designated as safety issue: No ]
  • Trough FVC response [L] on Day 15, Day 43, Day 85, Day 170 and Day 365 [ Time Frame: 52 weeks treatment ] [ Designated as safety issue: No ]
  • FVC AUC0-24h response [L] in sub-set of patients with 12-hour PFTs on Day 169 (This endpoint will be evaluated after combining the data from this and the replicate study 1237.5) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • SGRQ total score on Day 85 and Day 365 (This endpoint will be evaluated after combining the data from this and the replicate study 1237.5) [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • TDI focal score on Day 43, Day 85 and Day 365 (This endpoint will be evaluated after combining the data from this and the replicate study 1237.5) [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]

Enrollment: 2539
Study Start Date: September 2011
Study Completion Date: November 2013
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: tiotropium+olodaterol high dose FDC
Once daily 2 puffs solution for inhalation Respimat
Drug: tiotropium + olodaterol
fixed dose combination
Experimental: tiotropium+olodaterol low dose FDC
Once daily 2 puffs solution for inhalation Respimat
Drug: tiotropium + olodaterol
fixed dose combination
Active Comparator: olodaterol
Once daily 2 puffs solution for inhalation Respimat
Drug: olodaterol
one dose only
Active Comparator: tiotropium low dose
Once daily 2 puffs solution for inhalation Respimat
Drug: tiotropium
low dose or high dose
Active Comparator: tiotropium high dose
Once daily 2 puffs solution for inhalation Respimat
Drug: tiotropium
low dose or high dose

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  1. Diagnosis of chronic obstructive pulmonary disease.
  2. Relatively stable airway obstruction with post FEV1< 80% predicted normal and post FEV1/FVC <70%.
  3. Male or female patients, 40 years of age or older.
  4. Smoking history of more than 10 pack years.

Exclusion criteria:

  1. Significant disease other than COPD
  2. Clinically relevant abnormal lab values.
  3. History of asthma.
  4. Diagnosis of thyrotoxicosis
  5. Diagnosis of paroxysmal tachycardia
  6. History of myocardial infarction within 1 year of screening visit
  7. Unstable or life-threatening cardiac arrhythmia.
  8. Hospitalization for heart failure within the past year.
  9. Known active tuberculosis.
  10. Malignancy for which patient has undergone resection, radiation therapy or chemotherapy within last five years
  11. History of life-threatening pulmonary obstruction.
  12. History of cystic fibrosis.
  13. Clinically evident bronchiectasis.
  14. History of significant alcohol or drug abuse.
  15. Thoracotomy with pulmonary resection
  16. Oral ß-adrenergics.
  17. Oral corticosteroid medication at unstable doses
  18. Regular use of daytime oxygen therapy for more than one hour per day
  19. Pulmonary rehabilitation program in the six weeks prior to the screening visit
  20. Investigational drug within one month or six half lives (whichever is greater) prior to screening visit
  21. Known hypersensitivity to ß-adrenergic drugs, anticholinergics, BAC, EDTA
  22. Pregnant or nursing women.
  23. Women of childbearing potential not using a highly effective method of birth control
  24. Patients who are unable to comply with pulmonary medication restrictions
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01431287

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United States, California
1237.6.01106 Boehringer Ingelheim Investigational Site
Greer, California, United States
United States, Colorado
1237.6.01120 Boehringer Ingelheim Investigational Site
Fort Collins, Colorado, United States
United States, Connecticut
1237.6.01131 Boehringer Ingelheim Investigational Site
Danbury, Connecticut, United States
1237.6.01117 Boehringer Ingelheim Investigational Site
Waterbury, Connecticut, United States
United States, Florida
1237.6.01118 Boehringer Ingelheim Investigational Site
Deland, Florida, United States
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Tampa, Florida, United States
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1237.6.01134 Boehringer Ingelheim Investigational Site
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1237.6.01104 Boehringer Ingelheim Investigational Site
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1237.6.01135 Boehringer Ingelheim Investigational Site
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1237.6.01114 Boehringer Ingelheim Investigational Site
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1237.6.01115 Boehringer Ingelheim Investigational Site
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1237.6.01101 Boehringer Ingelheim Investigational Site
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1237.6.01113 Boehringer Ingelheim Investigational Site
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1237.6.01122 Boehringer Ingelheim Investigational Site
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1237.6.01137 Boehringer Ingelheim Investigational Site
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1237.6.01112 Boehringer Ingelheim Investigational Site
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1237.6.01133 Boehringer Ingelheim Investigational Site
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1237.6.01125 Boehringer Ingelheim Investigational Site
Spokane, Washington, United States
1237.6.01103 Boehringer Ingelheim Investigational Site
Tacoma, Washington, United States
Austria
1237.6.43006 Boehringer Ingelheim Investigational Site
Feldbach, Austria
1237.6.43005 Boehringer Ingelheim Investigational Site
Gänserndorf, Austria
1237.6.43002 Boehringer Ingelheim Investigational Site
Innsbruck, Austria
1237.6.43004 Boehringer Ingelheim Investigational Site
Leoben, Austria
1237.6.43001 Boehringer Ingelheim Investigational Site
Linz, Austria
1237.6.43003 Boehringer Ingelheim Investigational Site
Salzburg, Austria
Belgium
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1237.6.32004 Boehringer Ingelheim Investigational Site
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1237.6.32002 Boehringer Ingelheim Investigational Site
Jambes, Belgium
1237.6.32009 Boehringer Ingelheim Investigational Site
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1237.6.32001 Boehringer Ingelheim Investigational Site
Leuven, Belgium
1237.6.32006 Boehringer Ingelheim Investigational Site
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1237.6.32008 Boehringer Ingelheim Investigational Site
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1237.6.32010 Boehringer Ingelheim Investigational Site
Turnhout, Belgium
Brazil
1237.6.55013 Boehringer Ingelheim Investigational Site
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Sao Paulo, Brazil
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Sao Paulo, Brazil
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Sao Paulo, Brazil
Canada, Alberta
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Edmonton, Alberta, Canada
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Downsview, Ontario, Canada
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Xi'An, China
Colombia
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Cali, Colombia
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Floridablanca, Colombia
Croatia
1237.6.38503 Boehringer Ingelheim Investigational Site
Petrinja, Croatia
1237.6.38504 Boehringer Ingelheim Investigational Site
Rijeka, Croatia
1237.6.38502 Boehringer Ingelheim Investigational Site
Zadar, Croatia
1237.6.38501 Boehringer Ingelheim Investigational Site
Zagreb, Croatia
Germany
1237.6.49022 Boehringer Ingelheim Investigational Site
Aschaffenburg, Germany
1237.6.49017 Boehringer Ingelheim Investigational Site
Berlin, Germany
1237.6.49027 Boehringer Ingelheim Investigational Site
Frankfurt, Germany
1237.6.49026 Boehringer Ingelheim Investigational Site
Frankfurt, Germany
1237.6.49025 Boehringer Ingelheim Investigational Site
Großhansdorf, Germany
1237.6.49016 Boehringer Ingelheim Investigational Site
Halle, Germany
1237.6.49024 Boehringer Ingelheim Investigational Site
Hamburg, Germany
1237.6.49021 Boehringer Ingelheim Investigational Site
Hannover, Germany
1237.6.49019 Boehringer Ingelheim Investigational Site
Leipzig, Germany
1237.6.49028 Boehringer Ingelheim Investigational Site
Mainz, Germany
1237.6.49018 Boehringer Ingelheim Investigational Site
Rodgau/Dudenhofen, Germany
1237.6.49020 Boehringer Ingelheim Investigational Site
Schwerin, Germany
1237.6.49023 Boehringer Ingelheim Investigational Site
Teuchern, Germany
Hungary
1237.6.36001 Boehringer Ingelheim Investigational Site
Debrecen, Hungary
1237.6.36004 Boehringer Ingelheim Investigational Site
Gödöllö, Hungary
1237.6.36005 Boehringer Ingelheim Investigational Site
Pecs, Hungary
1237.6.36003 Boehringer Ingelheim Investigational Site
Sopron, Hungary
1237.6.36002 Boehringer Ingelheim Investigational Site
Szeged, Hungary
India
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Chennai, India
1237.6.91011 Boehringer Ingelheim Investigational Site
Coimbatore, India
1237.6.91004 Boehringer Ingelheim Investigational Site
Jaipur, India
1237.6.91002 Boehringer Ingelheim Investigational Site
Kolkatta, India
1237.6.91007 Boehringer Ingelheim Investigational Site
Maharastra, India
1237.6.91006 Boehringer Ingelheim Investigational Site
Mumbai, India
1237.6.91009 Boehringer Ingelheim Investigational Site
Nashik, Maharashtra, India
1237.6.91008 Boehringer Ingelheim Investigational Site
Pune, India
Ireland
1237.6.35304 Boehringer Ingelheim Investigational Site
County Limerick, Ireland
1237.6.35303 Boehringer Ingelheim Investigational Site
Dublin 24, Ireland
1237.6.35301 Boehringer Ingelheim Investigational Site
Dublin 4, Ireland
Japan
1237.6.81127 Boehringer Ingelheim Investigational Site
Abeno-ku, Osaka, Osaka, Japan
1237.6.81123 Boehringer Ingelheim Investigational Site
Aoi-ku, Shizuoka, Shizuoka, Japan
1237.6.81132 Boehringer Ingelheim Investigational Site
Chuo-ku, Kobe, Hyogo, Japan
1237.6.81121 Boehringer Ingelheim Investigational Site
Fukui, Fukui, Japan
1237.6.81137 Boehringer Ingelheim Investigational Site
Fukuyama, Hiroshima, Japan
1237.6.81109 Boehringer Ingelheim Investigational Site
Hachioji, Tokyo, Japan
1237.6.81134 Boehringer Ingelheim Investigational Site
Himeji, Hyogo, Japan
1237.6.81106 Boehringer Ingelheim Investigational Site
Hitachi, Ibaraki, Japan
1237.6.81139 Boehringer Ingelheim Investigational Site
Iizuka, Fukuoka, Japan
1237.6.81102 Boehringer Ingelheim Investigational Site
Iwamizawa, Hokkaido, Japan
1237.6.81117 Boehringer Ingelheim Investigational Site
Kamakura, Kanagawa, Japan
1237.6.81120 Boehringer Ingelheim Investigational Site
Kanazawa, Ishikawa, Japan
1237.6.81113 Boehringer Ingelheim Investigational Site
Kanazawa, Yokohama, Kanagawa, Japan
1237.6.81108 Boehringer Ingelheim Investigational Site
Kashiwa, Chiba, Japan
1237.6.81114 Boehringer Ingelheim Investigational Site
Kawasaki-ku, Kawasaki, Kanagawa, Japan
1237.6.81135 Boehringer Ingelheim Investigational Site
Kita-ku, Okayama, Okayama, Japan
1237.6.81126 Boehringer Ingelheim Investigational Site
Kita-ku, Sakai, Osaka, Japan
1237.6.81101 Boehringer Ingelheim Investigational Site
Kita-ku, Sapporo, Hokkaido, Japan
1237.6.81136 Boehringer Ingelheim Investigational Site
Kurashiki, Okayama, Japan
1237.6.81116 Boehringer Ingelheim Investigational Site
Minami-ku, Yokohama, Kanagawa, Japan
1237.6.81118 Boehringer Ingelheim Investigational Site
Minami-ku, Yokohama, Kanagawa, Japan
1237.6.81112 Boehringer Ingelheim Investigational Site
Mitaka, Tokyo, Japan
1237.6.81105 Boehringer Ingelheim Investigational Site
Mito, Ibaraki, Japan
1237.6.81142 Boehringer Ingelheim Investigational Site
Naha, Okinawa, Japan
1237.6.81131 Boehringer Ingelheim Investigational Site
Nishi-ku, Kobe, Hyogo, Japan
1237.6.81104 Boehringer Ingelheim Investigational Site
Obihiro, Hokkaido, Japan
1237.6.81141 Boehringer Ingelheim Investigational Site
Okinawa, Okinawa, Japan
1237.6.81110 Boehringer Ingelheim Investigational Site
Ota-ku, Tokyo, Japan
1237.6.81138 Boehringer Ingelheim Investigational Site
Sakaide, Kagawa, Japan
1237.6.81103 Boehringer Ingelheim Investigational Site
Sapporo, Hokkaido, Japan
1237.6.81144 Boehringer Ingelheim Investigational Site
Shimajiri-gun, Okinawa, Japan
1237.6.81140 Boehringer Ingelheim Investigational Site
Shimajiri-gun, Okinawa, Japan
1237.6.81145 Boehringer Ingelheim Investigational Site
Shinjuku-ku, Tokyo, Japan
1237.6.81111 Boehringer Ingelheim Investigational Site
Shinjuku-ku, Tokyo, Japan
1237.6.81107 Boehringer Ingelheim Investigational Site
Soka, Saitama, Japan
1237.6.81133 Boehringer Ingelheim Investigational Site
Takarazuka, Hyogo, Japan
1237.6.81122 Boehringer Ingelheim Investigational Site
Takayama, Gifu, Japan
1237.6.81143 Boehringer Ingelheim Investigational Site
Tomigusuku, Okinawa, Japan
1237.6.81128 Boehringer Ingelheim Investigational Site
Toyonaka, Osaka, Japan
1237.6.81124 Boehringer Ingelheim Investigational Site
Uji, Kyoto, Japan
1237.6.81130 Boehringer Ingelheim Investigational Site
Yabu, Hyogo, Japan
1237.6.81129 Boehringer Ingelheim Investigational Site
Yao, Osaka, Japan
1237.6.81119 Boehringer Ingelheim Investigational Site
Yokosuka, Kanagawa, Japan
Norway
1237.6.47005 Boehringer Ingelheim Investigational Site
Elverum, Norway
1237.6.47001 Boehringer Ingelheim Investigational Site
Hønefoss, Norway
1237.6.47002 Boehringer Ingelheim Investigational Site
Kløfta, Norway
1237.6.47004 Boehringer Ingelheim Investigational Site
Lierskogen, Norway
1237.6.47003 Boehringer Ingelheim Investigational Site
Oslo, Norway
1237.6.47007 Boehringer Ingelheim Investigational Site
SKI, Norway
1237.6.47008 Boehringer Ingelheim Investigational Site
Svelvik, Norway
Romania
1237.6.40004 Boehringer Ingelheim Investigational Site
Arad, Romania
1237.6.40005 Boehringer Ingelheim Investigational Site
Arad, Romania
1237.6.40001 Boehringer Ingelheim Investigational Site
Bucharest, Romania
1237.6.40002 Boehringer Ingelheim Investigational Site
Bucuresti, Romania
1237.6.40003 Boehringer Ingelheim Investigational Site
Cluj, Romania
Russian Federation
1237.6.07004 Boehringer Ingelheim Investigational Site
Moscow, Russian Federation
1237.6.07005 Boehringer Ingelheim Investigational Site
Moscow, Russian Federation
1237.6.07002 Boehringer Ingelheim Investigational Site
St. Petersburg, Russian Federation
1237.6.07003 Boehringer Ingelheim Investigational Site
St. Petersburg, Russian Federation
1237.6.07001 Boehringer Ingelheim Investigational Site
Yaroslavl, Russian Federation
Serbia
1237.6.38104 Boehringer Ingelheim Investigational Site
Belgrade, Serbia
1237.6.38105 Boehringer Ingelheim Investigational Site
Belgrade, Serbia
1237.6.38103 Boehringer Ingelheim Investigational Site
Belgrade, Serbia
1237.6.38102 Boehringer Ingelheim Investigational Site
Kragujevac, Serbia
1237.6.38101 Boehringer Ingelheim Investigational Site
Nis, Serbia
Slovakia
1237.6.42101 Boehringer Ingelheim Investigational Site
Bardejov, Slovakia
1237.6.42102 Boehringer Ingelheim Investigational Site
Bojnice, Slovakia
1237.6.42104 Boehringer Ingelheim Investigational Site
Kosice, Slovakia
1237.6.42107 Boehringer Ingelheim Investigational Site
Nitra, Slovakia
1237.6.42103 Boehringer Ingelheim Investigational Site
Spisska Nova Ves, Slovakia
1237.6.42106 Boehringer Ingelheim Investigational Site
Zilina, Slovakia
South Africa
1237.6.27002 Boehringer Ingelheim Investigational Site
Bellville, South Africa
1237.6.27004 Boehringer Ingelheim Investigational Site
Cape Town, South Africa
1237.6.27003 Boehringer Ingelheim Investigational Site
Cape Town, South Africa
1237.6.27001 Boehringer Ingelheim Investigational Site
Cape Town, South Africa
1237.6.27005 Boehringer Ingelheim Investigational Site
Pretoria, South Africa
Spain
1237.6.34008 Boehringer Ingelheim Investigational Site
Badalona (Barcelona), Spain
1237.6.34009 Boehringer Ingelheim Investigational Site
Barcelona, Spain
1237.6.34003 Boehringer Ingelheim Investigational Site
Barcelona, Spain
1237.6.34001 Boehringer Ingelheim Investigational Site
Hospitalet de Llobregat, Spain
1237.6.34002 Boehringer Ingelheim Investigational Site
Mérida, Spain
1237.6.34005 Boehringer Ingelheim Investigational Site
Pozuelo de Alarcón, Spain
1237.6.34004 Boehringer Ingelheim Investigational Site
San Juan de Alicante, Spain
1237.6.34006 Boehringer Ingelheim Investigational Site
Vic (Barcelona), Spain
Sweden
1237.6.46003 Boehringer Ingelheim Investigational Site
Boden, Sweden
1237.6.46002 Boehringer Ingelheim Investigational Site
Göteborg, Sweden
1237.6.46006 Boehringer Ingelheim Investigational Site
Härnösand, Sweden
1237.6.46005 Boehringer Ingelheim Investigational Site
Höllviken, Sweden
1237.6.46001 Boehringer Ingelheim Investigational Site
Lund, Sweden
1237.6.46004 Boehringer Ingelheim Investigational Site
Stockholm, Sweden
1237.6.46007 Boehringer Ingelheim Investigational Site
Uddevalla, Sweden
Taiwan
1237.6.88608 Boehringer Ingelheim Investigational Site
Kaohsiung, Taiwan
1237.6.88607 Boehringer Ingelheim Investigational Site
Kaohsiung City, Taiwan
1237.6.88602 Boehringer Ingelheim Investigational Site
New Taipei City, Taiwan
1237.6.88604 Boehringer Ingelheim Investigational Site
Taichung, Taiwan
1237.6.88605 Boehringer Ingelheim Investigational Site
Tainan, Taiwan
1237.6.88601 Boehringer Ingelheim Investigational Site
Taipei, Taiwan
1237.6.88603 Boehringer Ingelheim Investigational Site
Taoyuan County, Taiwan
Turkey
1237.6.90105 Boehringer Ingelheim Investigational Site
Ankara, Turkey
1237.6.90103 Boehringer Ingelheim Investigational Site
Denizli, Turkey
1237.6.90104 Boehringer Ingelheim Investigational Site
Istanbul, Turkey
1237.6.90101 Boehringer Ingelheim Investigational Site
Izmir, Turkey
1237.6.90102 Boehringer Ingelheim Investigational Site
Izmir, Turkey
United Kingdom
1237.6.44009 Boehringer Ingelheim Investigational Site
Blackpool, United Kingdom
1237.6.44002 Boehringer Ingelheim Investigational Site
Blackpool, United Kingdom
1237.6.44007 Boehringer Ingelheim Investigational Site
Bristol, United Kingdom
1237.6.44010 Boehringer Ingelheim Investigational Site
Chertsey, United Kingdom
1237.6.44011 Boehringer Ingelheim Investigational Site
Fleetwood, United Kingdom
1237.6.44001 Boehringer Ingelheim Investigational Site
Manchester, United Kingdom
1237.6.44008 Boehringer Ingelheim Investigational Site
Midsomer Norton, United Kingdom
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

No publications provided

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01431287     History of Changes
Other Study ID Numbers: 1237.6, 2009-010669-22
Study First Received: September 8, 2011
Last Updated: March 28, 2014
Health Authority: Austria: Medicines and Medical Devices Agency
Belgium: Federal Agency for Medicinal and Health Products
Brazil: National Health Surveillance Agency
Canada: Health Canada
China: Food and Drug Administration
Colombia: Instituto Nacional de Vigilancia de Medicamentos y Alimentos
Croatia: Agency for Medicinal Product and Medical Devices
Germany: Federal Institute for Drugs and Medical Devices
Hungary: National Institute of Pharmacy
India: Drugs Controller General of India
Ireland: Irish Medicines Board
Japan: Ministry of Health, Labor and Welfare
Mexico: Federal Commission for Protection Against Health Risks
Norway: Norwegian Medicines Agency
Romania: National Medicines Agency
Russia: Pharmacological Committee, Ministry of Health
Serbia and Montenegro: Agency for Drugs and Medicinal Devices
Slovakia: State Institute for Drug Control
South Africa: Medicines Control Council
Spain: Spanish Agency of Medicines
Sweden: Medical Products Agency
Taiwan : Food and Drug Administration
Turkey: Ministry of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Food and Drug Administration

Additional relevant MeSH terms:
Chronic Disease
Lung Diseases
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Disease Attributes
Pathologic Processes
Respiratory Tract Diseases
Tiotropium
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Parasympatholytics
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 28, 2014