An Efficacy and Safety Study to Compare Three Doses of BEA 2180 BR to Tiotropium and Placebo in the Respimat Inhaler.

NCT00528996 | Completed Phase 2 Results

• 2 other identifiers: 1205.142007-007946-42
• Study Type: interventional
• Target: 2,080
• Locations: 10 countries
• Sites: 178

Brief Summary

The primary objective of this study is to compare the bronchodilator efficacy of three doses (50 µg, 100 µg and 200 µg) of BEA 2180 delivered by the Respimat® once daily to placebo and tiotropium bromide delivered by the Respimat® in patients with COPD. Additional objectives include comparing the effects on dyspnea and health status.

Conditions

Pulmonary Disease, Chronic Obstructive

Outcome Measures

Primary Outcomes (1)

• Trough Forced Expiratory Volume in One Second (FEV1) Response After 24 Weeks

  Trough Forced expiratory volume in one second (FEV1) response was defined as the change from baseline in trough FEV1. Trough FEV1 was defined as the mean of the two FEV1 measurements recorded at the pre-dose measurements (40 and 15 minutes before the drug administration) at the end of the dosing interval (24 hours post previous drug administration from the Respimat® Inhaler). Baseline FEV1 was pre-treatment FEV1 values measured at Day 1 of treatment period (baseline) prior to administration of the first dose of study medication, which was the mean of the measurements recorded from the pulmonary function tests taken at 40 and 15 minutes prior to drug administration at Day 1 of treatment period.

  40 minutes (min) and 15 min before drug administration at baseline (Day 1 of treatment period) and Week 24.

Secondary Outcomes (30)

• Trough Forced Expiratory Volume in One Second (FEV1) Response After 1, 2, 4, 8, 12, and 18 Weeks

  40 minutes (min) and 15 min before drug administration at baseline (Day 1 of treatment period) and Week 1, 2, 4, 8, 12 and 18.

• Trough Forced Vital Capacity (FVC) Response After 1, 2, 4, 8, 12, 18, and 24 Weeks

  40 minutes (min) and 15 min before drug administration at baseline (Day 1 of treatment period) and Week 1, 2, 4, 8, 12, 18, and 24.

• Forced Expiratory Volume in One Second (FEV1) Area Under the Curve From 0 to 3 Hours (AUC0-3h) Response After 0, 4, 12 and 24 Weeks

  40 minutes (min) and 15 min before drug administration and 15 min, 30 min, 60 min, 2 hours, 3 hours after drug administration at Week 0 (Day 1 of treatment period), 4, 12, 24.

• Forced Vital Capacity (FVC) Area Under the Curve From 0 to 3 Hours (AUC0-3h) Response After 0, 4, 12 and 24 Weeks

  40 minutes (min) and 15 min before drug administration and 15 min, 30 min, 60 min, 2 hours, 3 hours after drug administration at Week 0 (Day 1 of treatment period), 4, 12, 24.

• Forced Expiratory Volume in One Second (FEV1) Peak Response After 0, 4, 12, and 24 Weeks

  40 minutes (min) and 15 min before drug administration and 15 min, 30 min, 60 min, 2 hours, 3 hours after drug administration at Week 0 (Day 1 of treatment period), 4, 12, 24.

Study Arms (5)

Placebo

PLACEBO COMPARATOR

Matching Placebo

Drug: Placebo

BEA 2180 BR low dose

EXPERIMENTAL

Low dose

Drug: BEA 2180 BR

BEA 2180 BR medium dose

EXPERIMENTAL

Medium dose

Drug: BEA 2180 BR

BEA 2180 BR high dose

EXPERIMENTAL

High dose

Drug: BEA 2180 BR

Tiotropium Bromide

EXPERIMENTAL

Tiotropium Bromide

Drug: Tiotropium Bromide

Interventions

BEA 2180 BR DRUG

Solution

BEA 2180 BR high dose; BEA 2180 BR low dose; BEA 2180 BR medium dose

Tiotropium Bromide DRUG

Solution

Tiotropium Bromide

Placebo DRUG

Solution

Placebo

Eligibility Criteria

• Age: 40 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients must sign an informed consent consistent with ICH-GCP guidelines prior to participation in the trial, which includes medication washout and restrictions.
• 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).
• Male or female patients 40 years of age or older.
• 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.
• 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.
• Patients must be able to inhale medication in a competent manner from the Respimat® inhaler (Appendix I)

You may not qualify if:

• Patients with significant diseases other than COPD will be excluded. A significant disease is defined as a disease which in the opinion of the investigator may either put the patient at risk because of participation in the study or a disease which may influence the results of the study or the patient ability to participate in the study.
• Patients with a recent history (one year or less) of myocardial infarction.
• Patients with any unstable or life-threatening cardiac arrhythmia.
• Patients who have been hospitalized for heart failure within the past 3 years.
• 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.
• Patients with known narrow-angle glaucoma.
• Patients with asthma or a history of asthma.
• Patients with a history of life-threatening pulmonary obstruction, or a history of cystic fibrosis or clinically evident bronchiectasis.
• Patients with known active tuberculosis.

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (178)

1205.14.061 Boehringer Ingelheim Investigational Site

Jasper, Alabama, United States

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1205.14.054 Boehringer Ingelheim Investigational Site

Mobile, Alabama, United States

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1205.14.042 Boehringer Ingelheim Investigational Site

Berkeley, California, United States

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1205.14.017 Boehringer Ingelheim Investigational Site

La Jolla, California, United States

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1205.14.022 Boehringer Ingelheim Investigational Site

Lakewood, California, United States

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1205.14.046 Boehringer Ingelheim Investigational Site

Riverside, California, United States

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1205.14.008 Boehringer Ingelheim Investigational Site

San Diego, California, United States

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1205.14.047 Boehringer Ingelheim Investigational Site

San Diego, California, United States

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1205.14.037 Boehringer Ingelheim Investigational Site

Sepulveda, California, United States

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1205.14.041 Boehringer Ingelheim Investigational Site

Denver, Colorado, United States

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1205.14.027 Boehringer Ingelheim Investigational Site

Fort Collins, Colorado, United States

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1205.14.034 Boehringer Ingelheim Investigational Site

Wheat Ridge, Colorado, United States

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1205.14.050 Boehringer Ingelheim Investigational Site

Stamford, Connecticut, United States

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1205.14.013 Boehringer Ingelheim Investigational Site

Bay Pines, Florida, United States

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1205.14.016 Boehringer Ingelheim Investigational Site

Clearwater, Florida, United States

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1205.14.048 Boehringer Ingelheim Investigational Site

DeLand, Florida, United States

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1205.14.043 Boehringer Ingelheim Investigational Site

Panama City, Florida, United States

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1205.14.040 Boehringer Ingelheim Investigational Site

Tampa, Florida, United States

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1205.14.007 Boehringer Ingelheim Investigational Site

Atlanta, Georgia, United States

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1205.14.053 Boehringer Ingelheim Investigational Site

Stockbridge, Georgia, United States

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1205.14.014 Boehringer Ingelheim Investigational Site

Coeur d'Alene, Idaho, United States

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1205.14.035 Boehringer Ingelheim Investigational Site

Olathe, Kansas, United States

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1205.14.057 Boehringer Ingelheim Investigational Site

New Orleans, Louisiana, United States

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1205.14.052 Boehringer Ingelheim Investigational Site

Shreveport, Louisiana, United States

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1205.14.036 Boehringer Ingelheim Investigational Site

Ann Arbor, Michigan, United States

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1205.14.019 Boehringer Ingelheim Investigational Site

Livonia, Michigan, United States

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1205.14.018 Boehringer Ingelheim Investigational Site

Chesterfield, Missouri, United States

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1205.14.032 Boehringer Ingelheim Investigational Site

St Louis, Missouri, United States

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1205.14.033 Boehringer Ingelheim Investigational Site

Reno, Nevada, United States

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1205.14.044 Boehringer Ingelheim Investigational Site

Brick, New Jersey, United States

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1205.14.056 Boehringer Ingelheim Investigational Site

Cherry Hill, New Jersey, United States

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1205.14.058 Boehringer Ingelheim Investigational Site

Summit, New Jersey, United States

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1205.14.010 Boehringer Ingelheim Investigational Site

Albuquerque, New Mexico, United States

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1205.14.062 Boehringer Ingelheim Investigational Site

Larchmont, New York, United States

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1205.14.028 Boehringer Ingelheim Investigational Site

Mineola, New York, United States

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1205.14.030 Boehringer Ingelheim Investigational Site

New Hyde Park, New York, United States

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1205.14.021 Boehringer Ingelheim Investigational Site

New York, New York, United States

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1205.14.059 Boehringer Ingelheim Investigational Site

Toledo, Ohio, United States

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Oklahoma City, Oklahoma, United States

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1205.14.031 Boehringer Ingelheim Investigational Site

Medford, Oregon, United States

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1205.14.003 Boehringer Ingelheim Investigational Site

Philadelphia, Pennsylvania, United States

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1205.14.004 Boehringer Ingelheim Investigational Site

Pittsburgh, Pennsylvania, United States

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1205.14.005 Boehringer Ingelheim Investigational Site

Johnston, Rhode Island, United States

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1205.14.029 Boehringer Ingelheim Investigational Site

Charleston, South Carolina, United States

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1205.14.055 Boehringer Ingelheim Investigational Site

Greer, South Carolina, United States

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1205.14.020 Boehringer Ingelheim Investigational Site

Spartanburg, South Carolina, United States

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1205.14.045 Boehringer Ingelheim Investigational Site

Fort Worth, Texas, United States

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1205.14.025 Boehringer Ingelheim Investigational Site

Houston, Texas, United States

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1205.14.060 Boehringer Ingelheim Investigational Site

Killeen, Texas, United States

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1205.14.002 Boehringer Ingelheim Investigational Site

San Antonio, Texas, United States

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1205.14.023 Boehringer Ingelheim Investigational Site

Richmond, Virginia, United States

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1205.14.024 Boehringer Ingelheim Investigational Site

Richmond, Virginia, United States

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1205.14.026 Boehringer Ingelheim Investigational Site

Roanoke, Virginia, United States

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1205.14.009 Boehringer Ingelheim Investigational Site

Spokane, Washington, United States

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1205.14.039 Boehringer Ingelheim Investigational Site

Spokane, Washington, United States

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1205.14.001 Boehringer Ingelheim Investigational Site

Morgantown, West Virginia, United States

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1205.14.151 Boehringer Ingelheim Investigational Site

Edmonton, Alberta, Canada

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1205.14.144 Boehringer Ingelheim Investigational Site

Vancouver, British Columbia, Canada

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1205.14.148 Boehringer Ingelheim Investigational Site

St. John's, Newfoundland and Labrador, Canada

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1205.14.143 Boehringer Ingelheim Investigational Site

Burlington, Ontario, Canada

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1205.14.142 Boehringer Ingelheim Investigational Site

Downsview, Ontario, Canada

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1205.14.150 Boehringer Ingelheim Investigational Site

Grimsby, Ontario, Canada

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1205.14.149 Boehringer Ingelheim Investigational Site

Mississauga, Ontario, Canada

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1205.14.146 Boehringer Ingelheim Investigational Site

Québec, Quebec, Canada

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1205.14.145 Boehringer Ingelheim Investigational Site

Sherbrooke, Quebec, Canada

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1205.14.381 Boehringer Ingelheim Investigational Site

Aschaffenburg, Germany

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1205.14.164 Boehringer Ingelheim Investigational Site

Berlin, Germany

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1205.14.167 Boehringer Ingelheim Investigational Site

Berlin, Germany

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1205.14.168 Boehringer Ingelheim Investigational Site

Berlin, Germany

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1205.14.172 Boehringer Ingelheim Investigational Site

Berlin, Germany

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1205.14.175 Boehringer Ingelheim Investigational Site

Berlin, Germany

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1205.14.177 Boehringer Ingelheim Investigational Site

Berlin, Germany

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1205.14.178 Boehringer Ingelheim Investigational Site

Berlin, Germany

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1205.14.377 Boehringer Ingelheim Investigational Site

Berlin, Germany

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1205.14.382 Boehringer Ingelheim Investigational Site

Berlin, Germany

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1205.14.387 Boehringer Ingelheim Investigational Site

Berlin, Germany

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1205.14.388 Boehringer Ingelheim Investigational Site

Berlin, Germany

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1205.14.165 Boehringer Ingelheim Investigational Site

Bonn, Germany

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1205.14.176 Boehringer Ingelheim Investigational Site

Cottbus, Germany

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1205.14.171 Boehringer Ingelheim Investigational Site

Dortmund, Germany

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1205.14.379 Boehringer Ingelheim Investigational Site

Geesthacht, Germany

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1205.14.174 Boehringer Ingelheim Investigational Site

Gelnhausen, Germany

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1205.14.173 Boehringer Ingelheim Investigational Site

Hamburg, Germany

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1205.14.375 Boehringer Ingelheim Investigational Site

Hanover, Germany

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1205.14.378 Boehringer Ingelheim Investigational Site

Koblenz, Germany

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1205.14.170 Boehringer Ingelheim Investigational Site

Lübeck, Germany

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1205.14.162 Boehringer Ingelheim Investigational Site

Mainz, Germany

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1205.14.384 Boehringer Ingelheim Investigational Site

Marburg, Germany

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1205.14.166 Boehringer Ingelheim Investigational Site

Minden, Germany

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1205.14.372 Boehringer Ingelheim Investigational Site

Neumünster, Germany

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1205.14.386 Boehringer Ingelheim Investigational Site

Neuruppin, Germany

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1205.14.385 Boehringer Ingelheim Investigational Site

Oschersleben, Germany

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1205.14.169 Boehringer Ingelheim Investigational Site

Rüdersdorf, Germany

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1205.14.179 Boehringer Ingelheim Investigational Site

Rüsselsheim am Main, Germany

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1205.14.376 Boehringer Ingelheim Investigational Site

Saarbrücken, Germany

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1205.14.374 Boehringer Ingelheim Investigational Site

Schwetzingen, Germany

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1205.14.371 Boehringer Ingelheim Investigational Site

Witten, Germany

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1205.14.373 Boehringer Ingelheim Investigational Site

Witten, Germany

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1205.14.279 Boehringer Ingelheim Investigational Site

Budakeszi, Hungary

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1205.14.273 Boehringer Ingelheim Investigational Site

Budapest, Hungary

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1205.14.283 Boehringer Ingelheim Investigational Site

Budapest, Hungary

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1205.14.287 Boehringer Ingelheim Investigational Site

Budapest, Hungary

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1205.14.286 Boehringer Ingelheim Investigational Site

Cegléd, Hungary

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1205.14.281 Boehringer Ingelheim Investigational Site

Debrecen, Hungary

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1205.14.272 Boehringer Ingelheim Investigational Site

Deszk, Hungary

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1205.14.289 Boehringer Ingelheim Investigational Site

Deszk, Hungary

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1205.14.271 Boehringer Ingelheim Investigational Site

Érd, Hungary

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1205.14.276 Boehringer Ingelheim Investigational Site

Gödöllö, Hungary

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1205.14.282 Boehringer Ingelheim Investigational Site

Gyula, Hungary

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1205.14.277 Boehringer Ingelheim Investigational Site

Komárom, Hungary

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1205.14.278 Boehringer Ingelheim Investigational Site

Mátraháza, Hungary

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1205.14.280 Boehringer Ingelheim Investigational Site

Mosonmagyaróvár, Hungary

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1205.14.285 Boehringer Ingelheim Investigational Site

Sopron, Hungary

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1205.14.275 Boehringer Ingelheim Investigational Site

Szarvas, Hungary

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1205.14.288 Boehringer Ingelheim Investigational Site

Százhalombatta, Hungary

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1205.14.284 Boehringer Ingelheim Investigational Site

Tatabánya, Hungary

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1205.14.274 Boehringer Ingelheim Investigational Site

Zalaegerszeg, Hungary

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1205.14.108 Boehringer Ingelheim Investigational Site

Cuernavaca, Mor. México, Mexico

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1205.14.101 Boehringer Ingelheim Investigational Site

Hermosillo, Sonora, Mexico

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1205.14.119 Boehringer Ingelheim Investigational Site

Metepec, Mexico

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1205.14.117 Boehringer Ingelheim Investigational Site

Mexico City, Mexico

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1205.14.120 Boehringer Ingelheim Investigational Site

Mexico City, Mexico

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1205.14.102 Boehringer Ingelheim Investigational Site

Monterrey, Mexico

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1205.14.116 Boehringer Ingelheim Investigational Site

Monterrey, Nuevo León, Mexico

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1205.14.105 Boehringer Ingelheim Investigational Site

Zapopan, Jal., Mexico

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1205.14.251 Boehringer Ingelheim Investigational Site

Chrzanów, Poland

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1205.14.253 Boehringer Ingelheim Investigational Site

Gdansk, Poland

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1205.14.254 Boehringer Ingelheim Investigational Site

Gdansk, Poland

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1205.14.246 Boehringer Ingelheim Investigational Site

Krakow, Poland

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1205.14.241 Boehringer Ingelheim Investigational Site

Lodz, Poland

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1205.14.242 Boehringer Ingelheim Investigational Site

Lodz, Poland

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1205.14.255 Boehringer Ingelheim Investigational Site

Miechów, Poland

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1205.14.248 Boehringer Ingelheim Investigational Site

Ruda Śląska, Poland

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1205.14.249 Boehringer Ingelheim Investigational Site

Tarnowskie Góry, Poland

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1205.14.252 Boehringer Ingelheim Investigational Site

Wilkowice, Poland

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1205.14.243 Boehringer Ingelheim Investigational Site

Wroclaw, Poland

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1205.14.244 Boehringer Ingelheim Investigational Site

Wroclaw, Poland

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1205.14.245 Boehringer Ingelheim Investigational Site

Wroclaw, Poland

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1205.14.247 Boehringer Ingelheim Investigational Site

Zabrze, Poland

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1205.14.301 Boehringer Ingelheim Investigational Site

Moscow, Russia

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1205.14.302 Boehringer Ingelheim Investigational Site

Moscow, Russia

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1205.14.303 Boehringer Ingelheim Investigational Site

Moscow, Russia

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1205.14.304 Boehringer Ingelheim Investigational Site

Moscow, Russia

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1205.14.305 Boehringer Ingelheim Investigational Site

Moscow, Russia

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1205.14.306 Boehringer Ingelheim Investigational Site

Moscow, Russia

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1205.14.310 Boehringer Ingelheim Investigational Site

Saint Petersburg, Russia

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1205.14.311 Boehringer Ingelheim Investigational Site

Saint Petersburg, Russia

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1205.14.312 Boehringer Ingelheim Investigational Site

Saint Petersburg, Russia

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1205.14.313 Boehringer Ingelheim Investigational Site

Saint Petersburg, Russia

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1205.14.314 Boehringer Ingelheim Investigational Site

Saint Petersburg, Russia

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1205.14.307 Boehringer Ingelheim Investigational Site

Yaroslavl, Russia

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1205.14.308 Boehringer Ingelheim Investigational Site

Yaroslavl, Russia

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1205.14.309 Boehringer Ingelheim Investigational Site

Yaroslavl, Russia

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1205.14.225 Boehringer Ingelheim Investigational Site

Gyeonggi-do, South Korea

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1205.14.228 Boehringer Ingelheim Investigational Site

Gyeonggi-do, South Korea

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1205.14.227 Boehringer Ingelheim Investigational Site

Seongdong-gu, South Korea

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1205.14.221 Boehringer Ingelheim Investigational Site

Seoul, South Korea

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1205.14.222 Boehringer Ingelheim Investigational Site

Seoul, South Korea

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1205.14.223 Boehringer Ingelheim Investigational Site

Seoul, South Korea

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1205.14.224 Boehringer Ingelheim Investigational Site

Seoul, South Korea

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1205.14.226 Boehringer Ingelheim Investigational Site

Seoul, South Korea

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1205.14.182 Boehringer Ingelheim Investigational Site

Badajoz, Spain

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1205.14.186 Boehringer Ingelheim Investigational Site

Cáceres, Spain

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1205.14.183 Boehringer Ingelheim Investigational Site

Madrid, Spain

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1205.14.191 Boehringer Ingelheim Investigational Site

Málaga, Spain

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1205.14.181 Boehringer Ingelheim Investigational Site

Terrassa (Barcelona), Spain

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1205.14.190 Boehringer Ingelheim Investigational Site

Torrevieja, Spain

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1205.14.189 Boehringer Ingelheim Investigational Site

Valencia, Spain

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1205.14.187 Boehringer Ingelheim Investigational Site

Vigo, Spain

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1205.14.207 Boehringer Ingelheim Investigational Site

Changhua, Taiwan

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1205.14.208 Boehringer Ingelheim Investigational Site

Chiayi City, Taiwan

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1205.14.210 Boehringer Ingelheim Investigational Site

Kaohsiung City, Taiwan

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1205.14.209 Boehringer Ingelheim Investigational Site

Kaohsiung County, Taiwan

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1205.14.205 Boehringer Ingelheim Investigational Site

Taichung, Taiwan

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1205.14.206 Boehringer Ingelheim Investigational Site

Taichung, Taiwan

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1205.14.202 Boehringer Ingelheim Investigational Site

Taipei, Taiwan

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1205.14.204 Boehringer Ingelheim Investigational Site

Taipei, Taiwan

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1205.14.201 Boehringer Ingelheim Investigational Site

Taoyuan, Taiwan

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Related Publications (1)

• 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.

  PMID: 23490224 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Tiotropium Bromide

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Scopolamine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring

Results Point of Contact

• Title: Boehringer Ingelheim, Call Center
• Organization: Boehringer Ingelheim

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2007
• First Posted: September 14, 2007
• Study Start: September 6, 2007
• Primary Completion: May 5, 2009
• Study Completion: May 5, 2009
• Last Updated: August 24, 2021
• Results First Posted: August 24, 2021

Record last verified: 2021-07

Locations

HU (19); ES (8); DE (33); KR (8); US (56); CA (9); ME (8); PL (14); TW (9); RU (14)