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Safety and Efficacy of 4-weeks Treatment of BIBW 2948 BS in Patients With Chronic Obstructive Bronchitis

NCT ID: NCT00726479

Last Updated: 2014-03-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2008-08-31

Brief Summary

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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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Detailed Description

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Conditions

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Pulmonary Disease, Chronic Obstructive Bronchitis, Chronic

Study Design

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Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Interventions

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BIBW 2948 BS

7.5 mg b.i.d, 15mg q.d, 15mg b.i.d

Intervention Type DRUG

Eligibility Criteria

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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

2. Patients with an acute or chronic hepatitis or alpha one antitrypsin deficiency or other liver disease.
3. Patients with an aspartate aminotransferase (AST), alanine aminotransferase (ALT) 1.5 x the upper limit of the normal range will be excluded regardless of the clinical condition. A repeat laboratory evaluation will not be conducted in these patients.
4. Patients with history of asthma or allergic rhinitis.
5. Patients with history of post-nasal drip the last 3 months prior visit 1.
6. Patients with a clinical diagnosis of bronchiectasis.
7. Patients currently treated with expectorants and/or mucolytics drug.
8. Patients taking medications with known cough promoting side effects (e.g., angiotensin converting enzyme inhibitors or angiotensin II receptor blockers) that in the opinion of the investigator are causing symptoms of cough.
9. Patients with any respiratory tract infection or COPD exacerbation in the 30 days prior the visit 1 or during the 1-week period prior to visit 2 (visit 2 will not be postponed and the patient will be discontinued from the study).
10. Patients who have had any change in their respiratory medications within the last 6 weeks prior the visit 1.
11. Patients with a history of thoracotomy for other reasons should be evaluated as per Exclusion 1.
12. Patients with a history of gastroesophageal reflux disease that have changed medication (dose intensification or a change in therapy) to treat this disease within the 6 weeks prior the visit 1.
13. Patients with a history of cancer, other than treated basal cell carcinoma, within the last five years.
14. Women of childbearing potential or who have not been post-menopausal for a duration for at least 2 years and have not had a hysterectomy or tubal ligation procedure.
15. Participation in another trial with an investigational drug within 30 days or 6 half lives (whichever is greater) of the start of the study.
16. A known hypersensitivity to lactose or any other component of the inhalation capsule or any other components of the inhalation capsule delivery system.
17. Patients who are currently in a pulmonary rehabilitation program or who have completed a pulmonary rehabilitation program within four weeks prior the visit 1.
18. Patients with a significant history of significant alcohol or drug abuse.
19. Patients with previous participation in this study.
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Responsible Party

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Boehringer Ingelheim

Principal Investigators

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Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

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1219.4.01001 Boehringer Ingelheim Investigational Site

Birmingham, Alabama, United States

Site Status

1219.4.01007 Boehringer Ingelheim Investigational Site

Phoenix, Arizona, United States

Site Status

1219.4.01006 Boehringer Ingelheim Investigational Site

Fort Collins, Colorado, United States

Site Status

1219.4.01002 Boehringer Ingelheim Investigational Site

Stamford, Connecticut, United States

Site Status

1219.4.01008 Boehringer Ingelheim Investigational Site

Rincon, Georgia, United States

Site Status

1219.4.01003 Boehringer Ingelheim Investigational Site

Greenville, South Carolina, United States

Site Status

1219.4.01004 Boehringer Ingelheim Investigational Site

Spartanburg, South Carolina, United States

Site Status

1219.4.01005 Boehringer Ingelheim Investigational Site

Union, South Carolina, United States

Site Status

1219.4.3306A Boehringer Ingelheim Investigational Site

Béthune, , France

Site Status

1219.4.3306B Boehringer Ingelheim Investigational Site

Béthune, , France

Site Status

1219.4.3302A Boehringer Ingelheim Investigational Site

Marseille, , France

Site Status

1219.4.3303A Boehringer Ingelheim Investigational Site

Montpellier, , France

Site Status

1219.4.3308A Boehringer Ingelheim Investigational Site

Nice, , France

Site Status

1219.4.3307A Boehringer Ingelheim Investigational Site

Nîmes, , France

Site Status

1219.4.3307B Boehringer Ingelheim Investigational Site

Nîmes, , France

Site Status

1219.4.3301A Boehringer Ingelheim Investigational Site

Paris, , France

Site Status

1219.4.3305A Boehringer Ingelheim Investigational Site

Toulouse, , France

Site Status

1219.4.3305B Boehringer Ingelheim Investigational Site

Toulouse, , France

Site Status

1219.4.49003 Boehringer Ingelheim Investigational Site

Eisenach, , Germany

Site Status

1219.4.49004 Boehringer Ingelheim Investigational Site

Hamburg, , Germany

Site Status

1219.4.49001 Boehringer Ingelheim Investigational Site

Hanover, , Germany

Site Status

1219.4.49006 Boehringer Ingelheim Investigational Site

Mainz, , Germany

Site Status

1219.4.49005 Boehringer Ingelheim Investigational Site

Rodgau-Dudenhofen, , Germany

Site Status

1219.4.49002 Boehringer Ingelheim Investigational Site

Rüdersdorf, , Germany

Site Status

Countries

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United States France Germany

Other Identifiers

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EUDRACT2007-003742-15

Identifier Type: -

Identifier Source: secondary_id

1219.4

Identifier Type: -

Identifier Source: org_study_id

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