Phase 2 N=52 Randomized Quadruple-blind Treatment

14729-D9831C00002- 1 Month Biopsy Study

Chronic Obstructive Pulmonary Disease

Bottom Line

View on ClinicalTrials.gov: NCT00766415 ↗

Enrolled (actual)

Serious AEs

2.0%

Results posted

Feb 2014

Primary outcome: Primary: Aggregated Pathology Score — 7.88; 8.15 Score on a scale

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: AZD1981 (Drug); Placebo (Drug)
Age: Adult, Older Adult · 40+ yrs
Sex: All
Sponsor: AstraZeneca
Primary completion: —

Outcome Measures

Outcome	Result	p-value
PRIMARY Aggregated Pathology Score	7.88; 8.15	—
PRIMARY Bronchoalveolar Lavage (BAL): Eosinophil Count (%)	-1.58; -1.45	—
PRIMARY Bronchoalveolar Lavage (BAL): Neutrophil Count (%)	-2.24; -5.67	—
PRIMARY Bronchoalveolar Lavage (BAL): Macrophages Count (%)	9.84; 10.68	—
PRIMARY Bronchoalveolar Lavage (BAL): Lymphocytes Count (%)	-1.47; -0.37	—
PRIMARY Bronchoalveolar Lavage (BAL): Epithelial Cells Count (%)	-4.18; -2.98	—
PRIMARY Bronchoalveolar Lavage (BAL): Total Cells Count	0.02; 0.04	—
PRIMARY Induced Sputum: Eosinophil Count (%)	-2.14; -0.81	—
PRIMARY Induced Sputum: Neutrophils Count (%)	0.70; 3.73	—
PRIMARY Induced Sputum: Macrophages Count (%)	1.31; -7.79	—
PRIMARY Induced Sputum: Lymphocytes Count (%)	-0.01; 0.02	—
PRIMARY Induced Sputum: Epithelial Cells Count (%)	-0.50; 4.11	—
PRIMARY Induced Sputum: Total Cells Count	-1.07; -1.69	—
SECONDARY Forced Expiratory Volume in 1 Second (FEV1)	-4.77; 6.16	—
SECONDARY Clinical Chronic Obstructive Pulmonary Disease (COPD) The Clinical COPD Questionnaire (CCQ)	-0.38; -0.34	—
SECONDARY Peak Expiratory Flow (PEF) Morning	2.57; -4.14	—
SECONDARY Peak Expiratory Flow (PEF) Evening	1.31; 1.46	—
SECONDARY Chronic Obstructive Pulmonary Disease (COPD) Symptom Night-time Awakenings Score	-0.23; -0.24	—
SECONDARY Chronic Obstructive Pulmonary Disease (COPD) Symptom Breathing Score	-0.25; -0.21	—
SECONDARY Chronic Obstructive Pulmonary Disease (COPD) Symptom Cough Score	-0.39; -0.35	—
SECONDARY Chronic Obstructive Pulmonary Disease (COPD) Symptom Sputum Score	-0.32; -0.38	—
SECONDARY Adverse Event (AE)	17; 14	—

Summary

The purpose of this study is to study histological changes, cellularity, clinical efficacy and safety of AZD1981 in patients with Chronic Obstructive Pulmonary Disease

Eligibility Criteria

Inclusion Criteria

Men or women 40 years or above
FEV1 between 40 and 80% of predicted normal value post-bronchodilator
Clinical diagnosis of COPD

Exclusion Criteria

Other clinically relevant disease or disorders
Exacerbation of COPD within 30 days

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00766415). 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.