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| ID | Type | Description | Link |
|---|---|---|---|
| EUDRACT2007-003742-15 |
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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
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BIBW 2948 BS | Drug | 7.5 mg b.i.d, 15mg q.d, 15mg b.i.d |
| Measure | Description | 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 |
| Measure | Description | 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 |
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Inclusion Criteria:
Patients must sign an informed consent consistent with ICH-GCP guidelines prior to participation in the trial, which includes medication washout and restrictions.
Male or female patients 40 years of age or older.
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
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.
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).
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.
Patients must be able to inhale medication in a competent manner from the HandiHaler® device for BIBW 2948 BS.
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:
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 1219.4.01001 Boehringer Ingelheim Investigational Site | Birmingham | Alabama | United States | |||
| 1219.4.01007 Boehringer Ingelheim Investigational Site |
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| Phoenix |
| Arizona |
| United States |
| 1219.4.01006 Boehringer Ingelheim Investigational Site | Fort Collins | Colorado | United States |
| 1219.4.01002 Boehringer Ingelheim Investigational Site | Stamford | Connecticut | United States |
| 1219.4.01008 Boehringer Ingelheim Investigational Site | Rincon | Georgia | United States |
| 1219.4.01003 Boehringer Ingelheim Investigational Site | Greenville | South Carolina | United States |
| 1219.4.01004 Boehringer Ingelheim Investigational Site | Spartanburg | South Carolina | United States |
| 1219.4.01005 Boehringer Ingelheim Investigational Site | Union | South Carolina | United States |
| 1219.4.3306A Boehringer Ingelheim Investigational Site | Béthune | France |
| 1219.4.3306B Boehringer Ingelheim Investigational Site | Béthune | France |
| 1219.4.3302A Boehringer Ingelheim Investigational Site | Marseille | France |
| 1219.4.3303A Boehringer Ingelheim Investigational Site | Montpellier | France |
| 1219.4.3308A Boehringer Ingelheim Investigational Site | Nice | France |
| 1219.4.3307A Boehringer Ingelheim Investigational Site | Nîmes | France |
| 1219.4.3307B Boehringer Ingelheim Investigational Site | Nîmes | France |
| 1219.4.3301A Boehringer Ingelheim Investigational Site | Paris | France |
| 1219.4.3305A Boehringer Ingelheim Investigational Site | Toulouse | France |
| 1219.4.3305B Boehringer Ingelheim Investigational Site | Toulouse | France |
| 1219.4.49003 Boehringer Ingelheim Investigational Site | Eisenach | Germany |
| 1219.4.49004 Boehringer Ingelheim Investigational Site | Hamburg | Germany |
| 1219.4.49001 Boehringer Ingelheim Investigational Site | Hanover | Germany |
| 1219.4.49006 Boehringer Ingelheim Investigational Site | Mainz | Germany |
| 1219.4.49005 Boehringer Ingelheim Investigational Site | Rodgau-Dudenhofen | Germany |
| 1219.4.49002 Boehringer Ingelheim Investigational Site | Rüdersdorf | Germany |
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D029481 | Bronchitis, Chronic |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001991 | Bronchitis |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D001982 | Bronchial Diseases |
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