Clinical trial NCT00766415: 14729-D9831C00002- 1 Month Biopsy Study
Official title: A Double-blind, Placebo-controlled, Randomised, Parallel Group Phase IIa Study to Evaluate the Histological Changes, Cellularity, Clinical Efficacy and Safety of AZD1981 in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: COPD
Moderate to severe COPD
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-10-06
Enrollment: 52
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

Primary outcomes:
measure: Aggregated Pathology Score
timeFrame: Before and after 1 month treatment
measure: Bronchoalveolar Lavage (BAL): Eosinophil Count (%)
timeFrame: Before and after 1 month treatment
measure: Bronchoalveolar Lavage (BAL): Neutrophil Count (%)
timeFrame: Before and after 1 month treatment
measure: Bronchoalveolar Lavage (BAL): Macrophages Count (%)
timeFrame: Before and after 1 month treatment
measure: Bronchoalveolar Lavage (BAL): Lymphocytes Count (%)
timeFrame: Before and after 1 month treatment
measure: Bronchoalveolar Lavage (BAL): Epithelial Cells Count (%)
timeFrame: Before and after 1 month treatment
measure: Bronchoalveolar Lavage (BAL): Total Cells Count
timeFrame: Before and after 1 month treatment
measure: Induced Sputum: Eosinophil Count (%)
timeFrame: Before and after 3 week treatment
measure: Induced Sputum: Neutrophils Count (%)
timeFrame: Before and after 3 week treatment
measure: Induced Sputum: Macrophages Count (%)
timeFrame: Before and after 3 week treatment
measure: Induced Sputum: Lymphocytes Count (%)
timeFrame: Before and after 3 week treatment
measure: Induced Sputum: Epithelial Cells Count (%)
timeFrame: Before and after 3 week treatment
measure: Induced Sputum: Total Cells Count
timeFrame: Before and after 3 week treatment
Secondary outcomes:
measure: Forced Expiratory Volume in 1 Second (FEV1)
timeFrame: Before and after 1 month treatment
measure: Clinical Chronic Obstructive Pulmonary Disease (COPD) The Clinical COPD Questionnaire (CCQ)
timeFrame: Before and after 1 month treatment
measure: Peak Expiratory Flow (PEF) Morning
timeFrame: Before and after 1 month treatment
measure: Peak Expiratory Flow (PEF) Evening
timeFrame: Before and after 1 month treatment
measure: Chronic Obstructive Pulmonary Disease (COPD) Symptom Night-time Awakenings Score
timeFrame: Before and after 1 month treatment
measure: Chronic Obstructive Pulmonary Disease (COPD) Symptom Breathing Score
timeFrame: Before and after 1 month treatment
measure: Chronic Obstructive Pulmonary Disease (COPD) Symptom Cough Score
timeFrame: Before and after 1 month treatment
measure: Chronic Obstructive Pulmonary Disease (COPD) Symptom Sputum Score
timeFrame: Before and after 1 month treatment
measure: Adverse Event (AE)
timeFrame: 1 month
Other outcomes:
Locations:
city: Frieburg
country: Germany
facility: Research Site
city: GROßHANSDORF
country: Germany
facility: Research Site
city: Hannover
country: Germany
facility: Research Site
city: Amsterdam
country: Netherlands
facility: Research Site
city: Leicester
country: United Kingdom
facility: Research Site
city: London
country: United Kingdom
facility: Research Site
city: Manchester
country: United Kingdom
facility: Research Site
city: Newcastle upon Tyne
country: United Kingdom
facility: Research Site
Study officials:
affiliation: Fraunhofer Institute
name: Norbert Krug
role: PRINCIPAL_INVESTIGATOR
References: