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Sponsored by: |
Boehringer Ingelheim Pharmaceuticals |
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Information provided by: | Boehringer Ingelheim Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00726479 |
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 a new validated patient reported outcome instrument (Cough and Sputum PRO) (see Appendix 1) in patients with COPD with symptoms associated with chronic bronchis. Additionally, the effect on symptoms of cough and sputum production based on clinical measures (volume and dry/wet weigh of the sputum, the cough frequency measured by electronic recording of thorax movement).
Secondary objective is to evaluate safety and tolerability (laboratory parameters, ECG, FEV1, FEV1/FVC, and daily morning PEF measurements).
Condition | Intervention | Phase |
---|---|---|
Pulmonary Disease, Chronic Obstructive Bronchitis, Chronic |
Drug: BIBW 2948 BS |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Safety and Efficacy of 4-Weeks Treatment of BIBW 2948 BS in Patients With Chronic Obstructive Bronchitis |
Estimated Enrollment: | 200 |
Study Start Date: | August 2008 |
Estimated Primary Completion Date: | April 2009 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 40 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
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
Exclusion Criteria:
United States, Alabama | |
1219.4.01001 Boehringer Ingelheim Investigational Site | |
Birmingham, Alabama, United States | |
United States, Arizona | |
1219.4.01007 Boehringer Ingelheim Investigational Site | |
Phoenix, Arizona, United States | |
United States, Colorado | |
1219.4.01006 Boehringer Ingelheim Investigational Site | |
Fort Collins, Colorado, United States | |
United States, Connecticut | |
1219.4.01002 Boehringer Ingelheim Investigational Site | |
Stamford, Connecticut, United States | |
United States, Georgia | |
1219.4.01008 Boehringer Ingelheim Investigational Site | |
Rincon, Georgia, United States | |
United States, South Carolina | |
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 | |
France | |
1219.4.3301A Boehringer Ingelheim Investigational Site | |
Paris Cedex 04, France | |
1219.4.3302A Boehringer Ingelheim Investigational Site | |
Marseille, France | |
1219.4.3303A Boehringer Ingelheim Investigational Site | |
Montpellier, France | |
1219.4.3305A Boehringer Ingelheim Investigational Site | |
Toulouse Cedex, France | |
1219.4.3305B Boehringer Ingelheim Investigational Site | |
Toulouse Cedex, France | |
1219.4.3306A Boehringer Ingelheim Investigational Site | |
Bethune Cedex, France | |
1219.4.3307A Boehringer Ingelheim Investigational Site | |
Nimes, France | |
1219.4.3307B Boehringer Ingelheim Investigational Site | |
Nimes, France | |
1219.4.3306B Boehringer Ingelheim Investigational Site | |
Bethune Cedex, France | |
1219.4.3308A Boehringer Ingelheim Investigational Site | |
Nice Cedex 1, France | |
Germany | |
1219.4.49006 Boehringer Ingelheim Investigational Site | |
Mainz, Germany | |
1219.4.49002 Boehringer Ingelheim Investigational Site | |
Ruedersdorf, Germany | |
1219.4.49003 Boehringer Ingelheim Investigational Site | |
Eisenach, Germany | |
1219.4.49004 Boehringer Ingelheim Investigational Site | |
Hamburg, Germany | |
1219.4.49005 Boehringer Ingelheim Investigational Site | |
Rodgau-Dudenhofen, Germany | |
1219.4.49001 Boehringer Ingelheim Investigational Site | |
Hannover, Germany |
Study Chair: | Boehringer Ingelheim | Boehringer Ingelheim Pharmaceuticals |
Responsible Party: | Boehringer Ingelheim ( Boehringer Ingelheim, Study Chair ) |
Study ID Numbers: | 1219.4, EUDRACT2007-003742-15 |
Study First Received: | July 30, 2008 |
Last Updated: | September 24, 2008 |
ClinicalTrials.gov Identifier: | NCT00726479 |
Health Authority: | United States: Food and Drug Administration; Germany: BfArM Bundesinstitut fuer Arzneimittel und Medizinprodukte; France: French Medicine Agency (AFSSAPS) |
Acute Disease Bronchitis, Chronic Lung Diseases, Obstructive Respiratory Tract Infections Respiratory Tract Diseases |
Lung Diseases Chronic Disease Bronchitis Pulmonary Disease, Chronic Obstructive |
Disease Attributes Pathologic Processes Bronchial Diseases |