An Efficacy and Safety Study to Compare Three Doses of BEA 2180 BR to Tiotropium and Placebo in the Respimat Inhaler.
NCT ID: NCT00528996
Last Updated: 2021-08-24
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
2080 participants
INTERVENTIONAL
2007-09-06
2009-05-05
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Study to Evaluate Efficacy and Safety of Inhaled BEA 2180 BR in COPD Patients
NCT02242279
Combination of Orally Inhaled BI1744CL/Tiotropium Bromide in Patients With Chronic Obstructive Pulmonary Disease ( COPD)
NCT00696020
High Dose Trial in COPD
NCT00128440
Efficacy and Safety of 4 Weeks of Treatment With Orally Inhaled BI1744/Tiotropium Bromide in Patients With Chronic Obstructive Pulmonary Disease (COPD)
NCT00720499
Dose Finding Study in COPD
NCT00122434
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Placebo
Matching Placebo
Placebo
Solution
BEA 2180 BR low dose
Low dose
BEA 2180 BR
Solution
BEA 2180 BR medium dose
Medium dose
BEA 2180 BR
Solution
BEA 2180 BR high dose
High dose
BEA 2180 BR
Solution
Tiotropium Bromide
Tiotropium Bromide
Tiotropium Bromide
Solution
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
BEA 2180 BR
Solution
Tiotropium Bromide
Solution
Placebo
Solution
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. All patients must have a diagnosis of chronic obstructive pulmonary disease (P95 4381) and must meet the following spirometric criteria:
Patients must have relatively stable, moderate to severe airway obstruction with an FEV1 (post-bronchodilator, 30 minutes post salbutamol/albuterol) \<80% of predicted normal and FEV1 less than or equal to 70% of FVC at the PFTs at Visit 1 (screening).
3. Male or female patients 40 years of age or older.
4. Patients must be current or ex-smokers with a smoking history of more than 10 pack years. Patients who have never smoked cigarettes must be excluded.
5. Patients must be able to perform technically acceptable pulmonary function tests and electronic PEFR measurements, and must be able to maintain records (Patient Daily Diary) during the study period as required in the protocol.
6. Patients must be able to inhale medication in a competent manner from the Respimat® inhaler (Appendix I)
Exclusion Criteria
2. Patients with clinically relevant abnormal baseline haematology, blood chemistry or urinalysis, if the abnormality defines a significant disease as defined in exclusion criterion No. 1.
3. Patients with a recent history (one year or less) of myocardial infarction.
4. Patients with any unstable or life-threatening cardiac arrhythmia.
5. Patients who have been hospitalized for heart failure within the past 3 years.
6. Patients with a malignancy for which the patient has undergone resection, radiation therapy or chemotherapy within the last five years. Patients with treated basal cell carcinoma are allowed.
8. Patients with known narrow-angle glaucoma.
9. Patients with asthma or a history of asthma.
10. Patients with a history of life-threatening pulmonary obstruction, or a history of cystic fibrosis or clinically evident bronchiectasis.
11. Patients with known active tuberculosis.
12. Patients with a history of and/or active significant alcohol or drug abuse. See exclusion criterion No. 1.
40 Years
100 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Boehringer Ingelheim
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Boehringer Ingelheim
Role: STUDY_CHAIR
Boehringer Ingelheim
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
1205.14.061 Boehringer Ingelheim Investigational Site
Jasper, Alabama, United States
1205.14.054 Boehringer Ingelheim Investigational Site
Mobile, Alabama, United States
1205.14.042 Boehringer Ingelheim Investigational Site
Berkeley, California, United States
1205.14.017 Boehringer Ingelheim Investigational Site
La Jolla, California, United States
1205.14.022 Boehringer Ingelheim Investigational Site
Lakewood, California, United States
1205.14.046 Boehringer Ingelheim Investigational Site
Riverside, California, United States
1205.14.008 Boehringer Ingelheim Investigational Site
San Diego, California, United States
1205.14.047 Boehringer Ingelheim Investigational Site
San Diego, California, United States
1205.14.037 Boehringer Ingelheim Investigational Site
Sepulveda, California, United States
1205.14.041 Boehringer Ingelheim Investigational Site
Denver, Colorado, United States
1205.14.027 Boehringer Ingelheim Investigational Site
Fort Collins, Colorado, United States
1205.14.034 Boehringer Ingelheim Investigational Site
Wheat Ridge, Colorado, United States
1205.14.050 Boehringer Ingelheim Investigational Site
Stamford, Connecticut, United States
1205.14.013 Boehringer Ingelheim Investigational Site
Bay Pines, Florida, United States
1205.14.016 Boehringer Ingelheim Investigational Site
Clearwater, Florida, United States
1205.14.048 Boehringer Ingelheim Investigational Site
DeLand, Florida, United States
1205.14.043 Boehringer Ingelheim Investigational Site
Panama City, Florida, United States
1205.14.040 Boehringer Ingelheim Investigational Site
Tampa, Florida, United States
1205.14.007 Boehringer Ingelheim Investigational Site
Atlanta, Georgia, United States
1205.14.053 Boehringer Ingelheim Investigational Site
Stockbridge, Georgia, United States
1205.14.014 Boehringer Ingelheim Investigational Site
Coeur d'Alene, Idaho, United States
1205.14.035 Boehringer Ingelheim Investigational Site
Olathe, Kansas, United States
1205.14.057 Boehringer Ingelheim Investigational Site
New Orleans, Louisiana, United States
1205.14.052 Boehringer Ingelheim Investigational Site
Shreveport, Louisiana, United States
1205.14.036 Boehringer Ingelheim Investigational Site
Ann Arbor, Michigan, United States
1205.14.019 Boehringer Ingelheim Investigational Site
Livonia, Michigan, United States
1205.14.018 Boehringer Ingelheim Investigational Site
Chesterfield, Missouri, United States
1205.14.032 Boehringer Ingelheim Investigational Site
St Louis, Missouri, United States
1205.14.033 Boehringer Ingelheim Investigational Site
Reno, Nevada, United States
1205.14.044 Boehringer Ingelheim Investigational Site
Brick, New Jersey, United States
1205.14.056 Boehringer Ingelheim Investigational Site
Cherry Hill, New Jersey, United States
1205.14.058 Boehringer Ingelheim Investigational Site
Summit, New Jersey, United States
1205.14.010 Boehringer Ingelheim Investigational Site
Albuquerque, New Mexico, United States
1205.14.062 Boehringer Ingelheim Investigational Site
Larchmont, New York, United States
1205.14.028 Boehringer Ingelheim Investigational Site
Mineola, New York, United States
1205.14.030 Boehringer Ingelheim Investigational Site
New Hyde Park, New York, United States
1205.14.021 Boehringer Ingelheim Investigational Site
New York, New York, United States
1205.14.059 Boehringer Ingelheim Investigational Site
Toledo, Ohio, United States
1205.14.012 Boehringer Ingelheim Investigational Site
Oklahoma City, Oklahoma, United States
1205.14.031 Boehringer Ingelheim Investigational Site
Medford, Oregon, United States
1205.14.003 Boehringer Ingelheim Investigational Site
Philadelphia, Pennsylvania, United States
1205.14.004 Boehringer Ingelheim Investigational Site
Pittsburgh, Pennsylvania, United States
1205.14.005 Boehringer Ingelheim Investigational Site
Johnston, Rhode Island, United States
1205.14.029 Boehringer Ingelheim Investigational Site
Charleston, South Carolina, United States
1205.14.055 Boehringer Ingelheim Investigational Site
Greer, South Carolina, United States
1205.14.020 Boehringer Ingelheim Investigational Site
Spartanburg, South Carolina, United States
1205.14.045 Boehringer Ingelheim Investigational Site
Fort Worth, Texas, United States
1205.14.025 Boehringer Ingelheim Investigational Site
Houston, Texas, United States
1205.14.060 Boehringer Ingelheim Investigational Site
Killeen, Texas, United States
1205.14.002 Boehringer Ingelheim Investigational Site
San Antonio, Texas, United States
1205.14.023 Boehringer Ingelheim Investigational Site
Richmond, Virginia, United States
1205.14.024 Boehringer Ingelheim Investigational Site
Richmond, Virginia, United States
1205.14.026 Boehringer Ingelheim Investigational Site
Roanoke, Virginia, United States
1205.14.009 Boehringer Ingelheim Investigational Site
Spokane, Washington, United States
1205.14.039 Boehringer Ingelheim Investigational Site
Spokane, Washington, United States
1205.14.001 Boehringer Ingelheim Investigational Site
Morgantown, West Virginia, United States
1205.14.151 Boehringer Ingelheim Investigational Site
Edmonton, Alberta, Canada
1205.14.144 Boehringer Ingelheim Investigational Site
Vancouver, British Columbia, Canada
1205.14.148 Boehringer Ingelheim Investigational Site
St. John's, Newfoundland and Labrador, Canada
1205.14.143 Boehringer Ingelheim Investigational Site
Burlington, Ontario, Canada
1205.14.142 Boehringer Ingelheim Investigational Site
Downsview, Ontario, Canada
1205.14.150 Boehringer Ingelheim Investigational Site
Grimsby, Ontario, Canada
1205.14.149 Boehringer Ingelheim Investigational Site
Mississauga, Ontario, Canada
1205.14.146 Boehringer Ingelheim Investigational Site
Québec, Quebec, Canada
1205.14.145 Boehringer Ingelheim Investigational Site
Sherbrooke, Quebec, Canada
1205.14.381 Boehringer Ingelheim Investigational Site
Aschaffenburg, , Germany
1205.14.164 Boehringer Ingelheim Investigational Site
Berlin, , Germany
1205.14.167 Boehringer Ingelheim Investigational Site
Berlin, , Germany
1205.14.168 Boehringer Ingelheim Investigational Site
Berlin, , Germany
1205.14.172 Boehringer Ingelheim Investigational Site
Berlin, , Germany
1205.14.175 Boehringer Ingelheim Investigational Site
Berlin, , Germany
1205.14.177 Boehringer Ingelheim Investigational Site
Berlin, , Germany
1205.14.178 Boehringer Ingelheim Investigational Site
Berlin, , Germany
1205.14.377 Boehringer Ingelheim Investigational Site
Berlin, , Germany
1205.14.382 Boehringer Ingelheim Investigational Site
Berlin, , Germany
1205.14.387 Boehringer Ingelheim Investigational Site
Berlin, , Germany
1205.14.388 Boehringer Ingelheim Investigational Site
Berlin, , Germany
1205.14.165 Boehringer Ingelheim Investigational Site
Bonn, , Germany
1205.14.176 Boehringer Ingelheim Investigational Site
Cottbus, , Germany
1205.14.171 Boehringer Ingelheim Investigational Site
Dortmund, , Germany
1205.14.379 Boehringer Ingelheim Investigational Site
Geesthacht, , Germany
1205.14.174 Boehringer Ingelheim Investigational Site
Gelnhausen, , Germany
1205.14.173 Boehringer Ingelheim Investigational Site
Hamburg, , Germany
1205.14.375 Boehringer Ingelheim Investigational Site
Hanover, , Germany
1205.14.378 Boehringer Ingelheim Investigational Site
Koblenz, , Germany
1205.14.170 Boehringer Ingelheim Investigational Site
Lübeck, , Germany
1205.14.162 Boehringer Ingelheim Investigational Site
Mainz, , Germany
1205.14.384 Boehringer Ingelheim Investigational Site
Marburg, , Germany
1205.14.166 Boehringer Ingelheim Investigational Site
Minden, , Germany
1205.14.372 Boehringer Ingelheim Investigational Site
Neumünster, , Germany
1205.14.386 Boehringer Ingelheim Investigational Site
Neuruppin, , Germany
1205.14.385 Boehringer Ingelheim Investigational Site
Oschersleben, , Germany
1205.14.169 Boehringer Ingelheim Investigational Site
Rüdersdorf, , Germany
1205.14.179 Boehringer Ingelheim Investigational Site
Rüsselsheim am Main, , Germany
1205.14.376 Boehringer Ingelheim Investigational Site
Saarbrücken, , Germany
1205.14.374 Boehringer Ingelheim Investigational Site
Schwetzingen, , Germany
1205.14.371 Boehringer Ingelheim Investigational Site
Witten, , Germany
1205.14.373 Boehringer Ingelheim Investigational Site
Witten, , Germany
1205.14.279 Boehringer Ingelheim Investigational Site
Budakeszi, , Hungary
1205.14.273 Boehringer Ingelheim Investigational Site
Budapest, , Hungary
1205.14.283 Boehringer Ingelheim Investigational Site
Budapest, , Hungary
1205.14.287 Boehringer Ingelheim Investigational Site
Budapest, , Hungary
1205.14.286 Boehringer Ingelheim Investigational Site
Cegléd, , Hungary
1205.14.281 Boehringer Ingelheim Investigational Site
Debrecen, , Hungary
1205.14.272 Boehringer Ingelheim Investigational Site
Deszk, , Hungary
1205.14.289 Boehringer Ingelheim Investigational Site
Deszk, , Hungary
1205.14.271 Boehringer Ingelheim Investigational Site
Érd, , Hungary
1205.14.276 Boehringer Ingelheim Investigational Site
Gödöllö, , Hungary
1205.14.282 Boehringer Ingelheim Investigational Site
Gyula, , Hungary
1205.14.277 Boehringer Ingelheim Investigational Site
Komárom, , Hungary
1205.14.278 Boehringer Ingelheim Investigational Site
Mátraháza, , Hungary
1205.14.280 Boehringer Ingelheim Investigational Site
Mosonmagyaróvár, , Hungary
1205.14.285 Boehringer Ingelheim Investigational Site
Sopron, , Hungary
1205.14.275 Boehringer Ingelheim Investigational Site
Szarvas, , Hungary
1205.14.288 Boehringer Ingelheim Investigational Site
Százhalombatta, , Hungary
1205.14.284 Boehringer Ingelheim Investigational Site
Tatabánya, , Hungary
1205.14.274 Boehringer Ingelheim Investigational Site
Zalaegerszeg, , Hungary
1205.14.108 Boehringer Ingelheim Investigational Site
Cuernavaca, Mor. México, , Mexico
1205.14.101 Boehringer Ingelheim Investigational Site
Hermosillo, Sonora, , Mexico
1205.14.119 Boehringer Ingelheim Investigational Site
Metepec, , Mexico
1205.14.117 Boehringer Ingelheim Investigational Site
Mexico City, , Mexico
1205.14.120 Boehringer Ingelheim Investigational Site
Mexico City, , Mexico
1205.14.102 Boehringer Ingelheim Investigational Site
Monterrey, , Mexico
1205.14.116 Boehringer Ingelheim Investigational Site
Monterrey, Nuevo León, , Mexico
1205.14.105 Boehringer Ingelheim Investigational Site
Zapopan, Jal., , Mexico
1205.14.251 Boehringer Ingelheim Investigational Site
Chrzanów, , Poland
1205.14.253 Boehringer Ingelheim Investigational Site
Gdansk, , Poland
1205.14.254 Boehringer Ingelheim Investigational Site
Gdansk, , Poland
1205.14.246 Boehringer Ingelheim Investigational Site
Krakow, , Poland
1205.14.241 Boehringer Ingelheim Investigational Site
Lodz, , Poland
1205.14.242 Boehringer Ingelheim Investigational Site
Lodz, , Poland
1205.14.255 Boehringer Ingelheim Investigational Site
Miechów, , Poland
1205.14.248 Boehringer Ingelheim Investigational Site
Ruda Śląska, , Poland
1205.14.249 Boehringer Ingelheim Investigational Site
Tarnowskie Góry, , Poland
1205.14.252 Boehringer Ingelheim Investigational Site
Wilkowice, , Poland
1205.14.243 Boehringer Ingelheim Investigational Site
Wroclaw, , Poland
1205.14.244 Boehringer Ingelheim Investigational Site
Wroclaw, , Poland
1205.14.245 Boehringer Ingelheim Investigational Site
Wroclaw, , Poland
1205.14.247 Boehringer Ingelheim Investigational Site
Zabrze, , Poland
1205.14.301 Boehringer Ingelheim Investigational Site
Moscow, , Russia
1205.14.302 Boehringer Ingelheim Investigational Site
Moscow, , Russia
1205.14.303 Boehringer Ingelheim Investigational Site
Moscow, , Russia
1205.14.304 Boehringer Ingelheim Investigational Site
Moscow, , Russia
1205.14.305 Boehringer Ingelheim Investigational Site
Moscow, , Russia
1205.14.306 Boehringer Ingelheim Investigational Site
Moscow, , Russia
1205.14.310 Boehringer Ingelheim Investigational Site
Saint Petersburg, , Russia
1205.14.311 Boehringer Ingelheim Investigational Site
Saint Petersburg, , Russia
1205.14.312 Boehringer Ingelheim Investigational Site
Saint Petersburg, , Russia
1205.14.313 Boehringer Ingelheim Investigational Site
Saint Petersburg, , Russia
1205.14.314 Boehringer Ingelheim Investigational Site
Saint Petersburg, , Russia
1205.14.307 Boehringer Ingelheim Investigational Site
Yaroslavl, , Russia
1205.14.308 Boehringer Ingelheim Investigational Site
Yaroslavl, , Russia
1205.14.309 Boehringer Ingelheim Investigational Site
Yaroslavl, , Russia
1205.14.225 Boehringer Ingelheim Investigational Site
Gyeonggi-do, , South Korea
1205.14.228 Boehringer Ingelheim Investigational Site
Gyeonggi-do, , South Korea
1205.14.227 Boehringer Ingelheim Investigational Site
Seongdong-gu, , South Korea
1205.14.221 Boehringer Ingelheim Investigational Site
Seoul, , South Korea
1205.14.222 Boehringer Ingelheim Investigational Site
Seoul, , South Korea
1205.14.223 Boehringer Ingelheim Investigational Site
Seoul, , South Korea
1205.14.224 Boehringer Ingelheim Investigational Site
Seoul, , South Korea
1205.14.226 Boehringer Ingelheim Investigational Site
Seoul, , South Korea
1205.14.182 Boehringer Ingelheim Investigational Site
Badajoz, , Spain
1205.14.186 Boehringer Ingelheim Investigational Site
Cáceres, , Spain
1205.14.183 Boehringer Ingelheim Investigational Site
Madrid, , Spain
1205.14.191 Boehringer Ingelheim Investigational Site
Málaga, , Spain
1205.14.181 Boehringer Ingelheim Investigational Site
Terrassa (Barcelona), , Spain
1205.14.190 Boehringer Ingelheim Investigational Site
Torrevieja, , Spain
1205.14.189 Boehringer Ingelheim Investigational Site
Valencia, , Spain
1205.14.187 Boehringer Ingelheim Investigational Site
Vigo, , Spain
1205.14.207 Boehringer Ingelheim Investigational Site
Changhua, , Taiwan
1205.14.208 Boehringer Ingelheim Investigational Site
Chiayi City, , Taiwan
1205.14.210 Boehringer Ingelheim Investigational Site
Kaohsiung City, , Taiwan
1205.14.209 Boehringer Ingelheim Investigational Site
Kaohsiung County, , Taiwan
1205.14.205 Boehringer Ingelheim Investigational Site
Taichung, , Taiwan
1205.14.206 Boehringer Ingelheim Investigational Site
Taichung, , Taiwan
1205.14.202 Boehringer Ingelheim Investigational Site
Taipei, , Taiwan
1205.14.204 Boehringer Ingelheim Investigational Site
Taipei, , Taiwan
1205.14.201 Boehringer Ingelheim Investigational Site
Taoyuan, , Taiwan
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Abrahams R, Moroni-Zentgraf P, Ramsdell J, Schmidt H, Joseph E, Karpel J. Safety and efficacy of the once-daily anticholinergic BEA2180 compared with tiotropium in patients with COPD. Respir Med. 2013 Jun;107(6):854-62. doi: 10.1016/j.rmed.2013.02.005. Epub 2013 Mar 13.
Related Links
Access external resources that provide additional context or updates about the study.
Related Info
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2007-007946-42
Identifier Type: -
Identifier Source: secondary_id
1205.14
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.