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

Completed · Phase 2 · Has a placebo group

Conditions studied: Pulmonary Disease, Chronic Obstructive

In brief

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.

Key facts

Study ID

NCT00528996

Run by

Boehringer Ingelheim

People needed

2080

Starts

2007-09-06

Expected to finish

2009-05-05

Last updated by the study team

2021-08-24

Who can join

Age: 40 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

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 clinically relevant abnormal baseline haematology, blood chemistry or urinalysis, if the abnormality defines a significant disease as defined in exclusion criterion No. 1.
• 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 symptomatic prostatic hyperplasia or bladder neck obstruction as defined in exclusion criteria No. 1.
• 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.
• Patients with a history of and/or active significant alcohol or drug abuse. See exclusion criterion No. 1.

Where it is running

• 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
• 1205.14.061 Boehringer Ingelheim Investigational Site — Jasper, Alabama, United States

Full record on ClinicalTrials.gov

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