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

Pulmonary Disease, Chronic Obstructive Clinical Trial

Official title:

A Phase II, Randomised, Double-blind, Placebo-controlled and Parallel Group Study to Evaluate the Safety and Efficacy of Four Weeks Treatment of 7.5 mg b.i.d, 15 mg q.d and 15 mg b.i.d. BIBW 2948 BS (Inhalation Powder, Hard Capsule for HandiHaler®) in Patients With COPD Associated With Chronic Bronchitis.

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00726479
• Other study ID #: 1219.4
• Secondary ID: EUDRACT2007-0037
• Status: Withdrawn
• Phase: Phase 2
• First received: July 30, 2008
• Last updated: March 26, 2014
• Start date: August 2008

Study information

• Verified date: March 2014
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationGermany: BfArM Bundesinstitut fuer Arzneimittel und MedizinprodukteFrance: French Medicine Agency (AFSSAPS)
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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 exclusion criteria No. 1.

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bronchitis
• Bronchitis, Chronic
• Chronic Disease
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• BIBW 2948 BS
7.5 mg b.i.d, 15mg q.d, 15mg b.i.d

Locations

Country	Name	City	State
France	1219.4.3306A Boehringer Ingelheim Investigational Site	Bethune Cedex
France	1219.4.3306B Boehringer Ingelheim Investigational Site	Bethune Cedex
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 Cedex 1
France	1219.4.3307A Boehringer Ingelheim Investigational Site	Nimes
France	1219.4.3307B Boehringer Ingelheim Investigational Site	Nimes
France	1219.4.3301A Boehringer Ingelheim Investigational Site	Paris Cedex 04
France	1219.4.3305A Boehringer Ingelheim Investigational Site	Toulouse Cedex
France	1219.4.3305B Boehringer Ingelheim Investigational Site	Toulouse Cedex
Germany	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	Hannover
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	Ruedersdorf
United States	1219.4.01001 Boehringer Ingelheim Investigational Site	Birmingham	Alabama
United States	1219.4.01006 Boehringer Ingelheim Investigational Site	Fort Collins	Colorado
United States	1219.4.01003 Boehringer Ingelheim Investigational Site	Greenville	South Carolina
United States	1219.4.01007 Boehringer Ingelheim Investigational Site	Phoenix	Arizona
United States	1219.4.01008 Boehringer Ingelheim Investigational Site	Rincon	Georgia
United States	1219.4.01004 Boehringer Ingelheim Investigational Site	Spartanburg	South Carolina
United States	1219.4.01002 Boehringer Ingelheim Investigational Site	Stamford	Connecticut
United States	1219.4.01005 Boehringer Ingelheim Investigational Site	Union	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Countries where clinical trial is conducted

United States,  France,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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