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

Boehringer Ingelheim

Status and phase: Completed; Phase 2

Conditions: Pulmonary Disease, Chronic Obstructive

Treatments: Drug: BEA 2180 BR; Drug: Tiotropium Bromide; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00528996

1205.14

2007-007946-42

Details and patient eligibility

About

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.

Enrollment: 2,080 patients

Sex: All

Ages: 40 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. All patients must sign an informed consent consistent with ICH-GCP guidelines prior to participation in the trial, which includes medication washout and restrictions.

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

1. 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.
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.
7. Patients with known symptomatic prostatic hyperplasia or bladder neck obstruction as defined in exclusion criteria No. 1.
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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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2,080 participants in 5 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Matching Placebo

Treatment:

Drug: Placebo

BEA 2180 BR low dose

Experimental group

Description:

Low dose

Treatment:

Drug: BEA 2180 BR

BEA 2180 BR medium dose

Experimental group

Description:

Medium dose

Treatment:

Drug: BEA 2180 BR

BEA 2180 BR high dose

Experimental group

Description:

High dose

Treatment:

Drug: BEA 2180 BR

Tiotropium Bromide

Experimental group

Description:

Tiotropium Bromide

Treatment:

Drug: Tiotropium Bromide