Phase 2 N=48 Randomized Quadruple-blind Treatment

Effect of BIBW 2948 BS in COPD

Pulmonary Disease, Chronic Obstructive · Bronchitis, Chronic

Bottom Line

View on ClinicalTrials.gov: NCT00423137 ↗

Enrolled (actual)

Serious AEs

8.3%

Results posted

Nov 2021

Primary outcome: Primary: Change From Baseline in Volume of Mucin Per Surface Area of Basal Lamina — 2.565; 1.180 micrometer^3/micrometer^2 — p=0.5305

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: BIBW 2948 BS (Drug); Placebo (Drug)
Age: Adult, Older Adult · 40+ yrs
Sex: All
Sponsor: Boehringer Ingelheim
Primary completion: Jul 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline in Volume of Mucin Per Surface Area of Basal Lamina	2.565; 1.180	0.5305
SECONDARY Change From Baseline of Volume of Mucin Per Volume of Epithelium (Vv mu, ep) in Endobronchial Biopsies	0.013; -0.036	0.1498
SECONDARY Change From Baseline in Bronchoalveolar Lavage (BAL) Cell Differential (in %)	0.46; 2.03; -3.22; -0.71; -0.15; -0.42	—
SECONDARY Change From Baseline in Bronchoalveolar Lavage (BAL) Cell Count	0.001; 0.005; -0.001; -0.007; -0.001; 0.001	—
SECONDARY Change From Baseline in Log MUC2 Mucin Gene Expression (RNA) Obtained in Epithelial Brushings	0.076; 0.411	0.4472
SECONDARY Change From Baseline in Log Mucin Gene (MUC5AC) Expression Level Obtained in Epithelial Brushings	0.074; -0.067	0.6829
SECONDARY Change From Baseline in Log Mucin Gene (MUC5B) Expression Level Obtained in Epithelial Brushings	-0.377; 0.194	0.1565
SECONDARY Change From Baseline in Log Mucin Gene (MUC8) Expression Level Obtained in Epithelial Brushings	0.639; 1.720	0.3709
SECONDARY Change From Baseline in Epidermal Growth Factor Receptor (EGRF) Internalization Assay in Epithelial Brushings - Cells With Bright Spots With Marker	103.122; 51.039	0.0044 sig
SECONDARY Change From Baseline in Epidermal Growth Factor Receptor (EGRF) Internalization Assay in Epithelial Brushings - EGRF Spots at Nucleus	112.955; 45.943	0.0056 sig
SECONDARY Change From Baseline in Epidermal Growth Factor Receptor (EGFR) Internalization Assay in Epithelial Brushings - EGRF Spots With Marker	106.671; 44.100	0.0025 sig
SECONDARY Change From Baseline in Epidermal Growth Factor Receptor (EGFR) Internalization Assay in Epithelial Brushings - Total Area Bright Spots With Marker	95.397; 55.330	0.0439 sig
SECONDARY Change From Baseline in Epidermal Growth Factor Receptor (EGFR) Internalization Assay in Epithelial Brushings - EGFR Spots	117.074; 59.614	0.0129 sig
SECONDARY Change From Baseline in Epidermal Growth Factor Receptor (EGFR) Internalization Assay in Epithelial Brushings - EGFR Spots at Nucleus With Marker	110.045; 54.713	0.0037 sig
SECONDARY Change From Baseline in Number of Goblet Cells Per Surface Area of Basel Lamina	0.001; 0.001	0.9076
SECONDARY Change From Baseline in Number of Goblet Cells Per Volume of Epithelium	14332.8; 879.408	0.4121
SECONDARY Change From Baseline in Goblet Cell Volume	-607.26; -685.87	0.7948
SECONDARY Change From Baseline of Interleukin-8 (IL-8) Levels in Bronchoalveolar Lavage	-0.069; 0.126	0.0640
SECONDARY Change From Baseline in Myeloperoxidase (MPO) Levels in Bronchoalveolar Lavage	-0.003; 0.005	0.0587

Summary

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

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00423137). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.