Effect of BIBW 2948 BS in COPD

Boehringer Ingelheim

Status and phase: Completed; Phase 2

Conditions: Pulmonary Disease, Chronic Obstructive; Bronchitis, Chronic

Treatments: Drug: BIBW 2948 BS; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00423137

2006-001975-40

1219.5

Details and patient eligibility

About

Study of BIBW 2948 BS in Patients with COPD and Chronic Bronchitis

Enrollment: 48 patients

Sex: All

Ages: 40 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• COPD smokers
• ages between 40 and 70

Exclusion criteria

• Significant other diseases
• abnormal hematology
• abnormal liver function
• psychiatric disorders
• pulmonary obstruction
• asthma, allergic rhinitis
• dependance on oxygen
• patients with history of myocardial infarction
• patients with history of cancer
• women of child bearing potential
• antiplatelet or anticoagulation therapy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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48 participants in 4 patient groups, including a placebo group

Placebo - low dose

Placebo Comparator group

Description:

Twice daily (b.i.d.)

Treatment:

Drug: Placebo

Placebo - high dose

Placebo Comparator group

Description:

Twice daily (b.i.d.)

Treatment:

Drug: Placebo

BIBW2948 - low dose

Experimental group

Description:

Twice daily (b.i.d.)

Treatment:

Drug: BIBW 2948 BS

BIBW2948 - high dose

Experimental group

Description:

Twice daily (b.i.d.)

Treatment:

Drug: BIBW 2948 BS