Bronchitis, Chronic, Pulmonary Disease, Chronic Obstructive
Conditions
Brief summary
The primary objective of this study is to investigate the effect of 4-week treatment with 7.5 mg b.i.d, 15 mg q.d and 15 mg b.i.d. BIBW 2948 BS and placebo on cough and sputum as determined by the CASA-Q (Cough and Sputum Assessment Questionnaire
Interventions
DRUGBIBW 2948 BS
7.5 mg b.i.d, 15mg q.d, 15mg b.i.d
Sponsors
Boehringer Ingelheim
Study design
Intervention model
PARALLEL
Primary purpose
TREATMENT
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients must sign an informed consent consistent with ICH-GCP guidelines prior to participation in the trial, which includes medication washout and restrictions. 2. Male or female patients 40 years of age or older. 3. Patients must have a diagnosis of COPD defined by a post-bronchodilator FEV1 \< 80% of predicted and FEV1 \< 70% of FVC (to be obtained 30 minutes after administration of salbutamol HFA). Predicted normal values will be calculated according to ECSC (R94-1408). For Height measured in inches Males: FEV1 predicted (L) = 4.30 x (height (inches)/39.37) - 0.029 x age (yrs) - 2.49 Females: FEV1 predicted (L) = 3.95 x \[height (inches)/39.37\] - 0.025 x age (yrs) - 2.60 or Height measured in meters Males: FEV1 predicted (L) = 4.30 x \[height (meters)\] - 0.029 x age (yrs) - 2.49 Females: FEV1 predicted (L) = 3.95 x \[height (meters)\] - 0.025 x age (yrs) - 2.60 4. Patients must have a diagnosis of chronic bronchitis symptoms i.e., cough and sputum expectoration on most days for at least three months in each of two consecutive years. 5. Patients must be a current or ex-smoker with a smoking history of sup or egal to 10 pack years (Patients who have never smoked cigarettes must be excluded). 6. Patients must be able to perform all specified procedures and able to maintain all necessary records during the study period as required in the protocol. 7. Patients must be able to inhale medication in a competent manner from the HandiHaler® device for BIBW 2948 BS. 8. Patients must be able to read and understand the questionnaires in the languages provided (English in the U.S., French in France and German in Germany).
Exclusion criteria
1. Patients with significant diseases other than COPD will be excluded. A significant disease is defined as a disease or condition which, in the opinion of the investigator, may put the patients at risk because of participation in the study or may influence either the results of the study or the patient's 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint of this study will be change in the Cough and Sputum PRO symptom domain scores from baseline (Visit 2) to the end of the 4 weeks treatment period. | 4 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Cough and Sputum PRO symptom domain scores Cough and Sputum PRO impact domain scores 24 hours sputum wet/dry weight and volume Cough frequency as recorded by electronic recording of thorax movement Interleukin 8 P. Level Cough and Sputum Rating Sc | 4 weeks |
Countries
France, Germany, United States
Outcome results
None listed