Tolerability/Safety and Efficacy of Inhaled AZD4818 in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)

Phase 2

Completed

• Conditions: Chronic Obstructive Pulmonary Disease (COPD)
• Interventions: Drug: AZD4818; Drug: Placebo

• Registration Number: NCT00629239
• Lead Sponsor: AstraZeneca

Brief Summary

The purpose of this study is to see if treatment with AZD4818 for four weeks is tolerable, safe and effective in treating COPD and, if so, how it compares with placebo.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-01
• Study First Submitted: 2008-02-25
• Study First Submitted QC: 2008-02-25
• Study First Posted: 2008-03-05
• Primary Completion: 2008-06
• Study Completion: 2008-08
• Status Verified: 2010-11
• Results First Submitted: 2010-11-04
• Results First Submitted QC: 2010-11-04
• Last Update Submitted: 2010-11-04
• Results First Posted: 2010-12-06
• Last Update Posted: 2010-12-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 65

Inclusion Criteria

• Clinical diagnosis of COPD, with symptoms for more than 1 year
• Current or ex-smokers with a smoking history of at least 10 pack-years (1 pack-year=20 cigarettes/day for 1 year)
• Lung function (FEV1) 40 to 80% of the predicted normal value after using a short acting bronchodilator

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Exclusion Criteria

• Clinical suspicion of active tuberculosis
• Any current clinically significant respiratory tract disorder other than COPD
• History of current clinically relevant arrhythmia, heart block, ECG abnormalities, or unstable angina

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	AZD4818	AZD4818
2	Placebo	Placebo

Primary Outcome Measures

Name	Time	Method
Number of Patients Experiencing Adverse Events	At all study visits	Number of patients who had an Adverse Event

Secondary Outcome Measures

Name	Time	Method
Forced Expiratory Volume 1 (FEV1)	Before treatment and after 1, 2, 3 and 4 weeks of treatment	Change in (FEV1) from baseline to end of treatment
Forced Vital Capacity (FVC)	Before treatment and after 1, 2, 3 and 4 weeks of treatment	Change in FVC from baseline to end of treatment
Vital Capacity (VC)	Before treatment and after 1, 2, 3 and 4 weeks of treatment	Change in VC from baseline to end of treatment
Inspiratory Capacity (IC)	Before treatment and after 1, 2, 3 and 4 weeks of treatment	Change from IC baseline to end of treatment
Forced Expiratory Flow (FEF) 25%-75%	Before treatment and after 1, 2, 3 and 4 weeks of treatment	Change in FEF from baseline to end of treatment
Peak Expiratory Flow (PEF) Morning	Daily during run-in and treatment	Change from average during run-in to average during treatment
Peak Expiratory Flow (PEF) Evening	Daily during run-in and treatment	Change in PEF from average during run-in to average during treatment
The Clinical COPD ( Chronic Obstructive Pulmonary Disease) Questionnaire (CCQ) Total	Before treatment and after 1, 2, 3 and 4 weeks of treatment	Change from baseline to end of treatment in score , The total scores vary between 0 (never/not limited at all) to 6 (almost all the time/totally limited)
Chronic Obstructive Pulmonary Disease (COPD) Symptoms, Breathlessness	Daily during run-in and treatment	Change from average during run-in to average during treatment. Scores on a Scale, 5-point Likert-type scale, ranging from 0 (none) to 4 (severe).
Chronic Obstructive Pulmonary Disease (COPD) Symptoms, Chest Tightness	Daily during run-in and treatment	Change from average during run-in to average during treatment. Scores on a Scale, 5-point Likert-type scale, ranging from 0 (none) to 4 (severe).
Chronic Obstructive Pulmonary Disease (COPD) Symptoms, Cough Score	Daily during run-in and treatment	Change from average during run-in to average during treatment. Scores on a Scale, 5-point Likert-type scale, ranging from 0 (none) to 4 (severe).
Chronic Obstructive Pulmonary Disease (COPD) Symptoms, Sleep Score	Daily during run-in and treatment	Change from average during run-in to average during treatmentScores on a Scale, 5-point Likert-type scale, ranging from 0 (none) to 4 (severe).
6-minute Walk Test	Before treatment and after 4 weeks of treatment	Change from baseline to end of treatment

Trial Locations

Locations (1)

Research Site; 🇸🇪 Lund, Sweden