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

Study Overview
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Brief Summary
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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.

Official Title
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A 4-week Double-blind, Placebo-controlled, Randomized, Parallel Group Phase IIa Study to Assess the Tolerability/Safety and Efficacy of Inhaled AZD4818 in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)

Conditions
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Chronic Obstructive Pulmonary Disease (COPD)

Intervention / Treatment
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* Drug: AZD4818
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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 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

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>AZD4818 | Drug: AZD4818<br>* Dry Powder, inhalation, b.i.d., 4 weeks<br>|
| Placebo Comparator: 2<br>Placebo | Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients Experiencing Adverse Events | Number of patients who had an Adverse Event | At all study visits | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Forced Expiratory Volume 1 (FEV1) | Change in (FEV1) from baseline to end of treatment | Before treatment and after 1, 2, 3 and 4 weeks of treatment | 
| Forced Vital Capacity (FVC) | Change in FVC from baseline to end of treatment | Before treatment and after 1, 2, 3 and 4 weeks of treatment | 
| Vital Capacity (VC) | Change in VC from baseline to end of treatment | Before treatment and after 1, 2, 3 and 4 weeks of treatment | 
| Inspiratory Capacity (IC) | Change from IC baseline to end of treatment | Before treatment and after 1, 2, 3 and 4 weeks of treatment | 
| Forced Expiratory Flow (FEF) 25%-75% | Change in FEF from baseline to end of treatment | Before treatment and after 1, 2, 3 and 4 weeks of treatment | 
| Peak Expiratory Flow (PEF) Morning | Change from average during run-in to average during treatment | Daily during run-in and treatment | 
| Peak Expiratory Flow (PEF) Evening | Change in PEF from average during run-in to average during treatment | Daily during run-in and treatment | 
| The Clinical COPD ( Chronic Obstructive Pulmonary Disease) Questionnaire (CCQ) Total | 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) | Before treatment and after 1, 2, 3 and 4 weeks of treatment | 
| Chronic Obstructive Pulmonary Disease (COPD) Symptoms, Breathlessness | 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). | Daily during run-in and treatment | 
| Chronic Obstructive Pulmonary Disease (COPD) Symptoms, Chest Tightness | 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). | Daily during run-in and treatment | 
| Chronic Obstructive Pulmonary Disease (COPD) Symptoms, Cough Score | 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). | Daily during run-in and treatment | 
| Chronic Obstructive Pulmonary Disease (COPD) Symptoms, Sleep Score | 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). | Daily during run-in and treatment | 
| 6-minute Walk Test | Change from baseline to end of treatment | Before treatment and after 4 weeks of treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COPD, tolerability, inhalation