Patients with a diagnosis of Chronic Obstructive Pulmonary Diease associated with chronic bronchitis. Patients must be in stable condition and current or ex-smoher.
Conditions
Interventions
Product Name: BIBW 2948
Product Code: BIBW 2948
Pharmaceutical Form: Inhalation powder, hard capsule
Current Sponsor code: BIBW 2948
Concentration unit: mg milligram(s)
Concentration type: equal
Conce
Sponsors
Boehringer Ingelheim France
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1- male or female patients 40 years of age or older 2- diagnosis of COPD defined by a post-bronchodilator FEV1 10 pack years 5- must be able to perform all specified procedures 6- must be able to inhale medication from the HandiHaler device for BIBW 2948 BS. 7- Must be able to read and understand the questionnaire in the languages provided (English in the U.S, french in France and German in germany) 8- must sign and informed consent prior to participation in the trial. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1- significant diseases other than CODP will be excluded. 2- Acute or chronic hepatitis or alpha one antitrypsin deficiency or other liver disease. 3- AST or ALT above 1.5x the upper limit of the normal range. 4- history of asthma or allergic rhinitis 5- history of post-nasal drip the last 3 months prior visit 1 6- clinical diagnosis of bronchiextasis 7- patient currently treated with expectorants and/or mucolytic drugs. 8- patient taking medications with known cough promoting side effects that in the opinion of the investigator are causing symptoms of cough. 9- patient with any history tract infrection or COPD exacerbation in the 30 days prior visit 1. 10- Any change in the respiratory medication within the last 6 weeks prior visit 1. 11- history of thoracotomy 12- history of gastroesophageal reflux disease that have changed medication to treat this disease within the last 6 weeks prior visit 1. 13- history of cancer other than treated basal cell carcinoma within the last 5 years. 14- women of childbearing potential or who have not been post-menopausal for a duration dor at least 2 years and have not had a hysterectomy or tubal ligation procedure. A serum pregnancy test at visit 1 will be performed for all women. 15- participation in another trial with an investigational drug within 30 days or 6 half lives of the start of the study. 16- known hypersensitivity to lactose or any other component of the inhalation capsule. 17- patinets who are currently in a pulmonary rehabilitation program or who have completed a pulmonary rehabilitation program within the last 4 weeks prior visit 1. 18- significant history of alcohol or drug abuse. 19- previous participation in this study or current participation in other clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: to investigate the effect of the 4-week treatment with 7.5 mg b.i.d., 15 mg q.d. and 15 mg b.i.d. BIBW2948 BS and placebo on cough and sputum as determined by the CASA-Q (Cough and Sputum Assessment Questionnaire) in patient with COPD associated with chronic bronchitis.;Secondary Objective: ;Primary end point(s): the primary endpoint will be the change in CASA-Q symptom domain scores from baseline (visit2) to the end of the 4-week treatment period. | — |
Countries
France
Outcome results
None listed