Safety/Tolerability Study With AZD1236 in Chronic Obstructive Pulmonary Disease (COPD) Patients

Study Overview
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Brief Summary
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The primary aim of this study is to investigate the tolerability and safety of AZD 1236 compared with placebo (inactive substance) in COPD patients by assessment of Adverse Events, vital signs and laboratory safety assessments.

Official Title
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A 6 Week Double-Blind, Placebo-controlled, Randomised, Parallel Group Phase IIa Study to Assess the Tolerability/Safety and Efficacy of AZD1236as an Oral Tablet in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)

Conditions
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Chronic Obstructive Pulmonary Disease

Intervention / Treatment
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* Drug: AZD1236
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of COPD for 1 month Men or postmenopausal women Spirometry values indicating reduced lung function Smoking history equivalent to using 20 cigarettes a day for 10 years Exclusion Criteria: Any current respiratory tract disorders other than COPD Requirement for regular oxygen therapy Use of oral or parenteral glucocorticosteroids within 30 days prior to the study

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: AZD1236<br>* oral tablet, 75 mg, twice daily during 6 weeks<br>|
| Placebo Comparator: 2<br> | Drug: Placebo<br>* Dosing to match AZD1236<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Forced Expiratory Volume in 1 Second (FEV1) | Change in FEV1 from baseline to end of treatment | Before treatment and after 1, 2, 4 and 6 weeks of treatment | 
| Forced Vital Capacity (FVC) | Change in FVC from baseline to end of treatment | Before treatment and after 1, 2, 4 and 6 weeks of treatment | 
| Vital Capacity (VC) | Change in VC from baseline to end of treatment | Before treatment and after 1, 2, 4 and 6 weeks of treatment | 
| Inspiratory Capacity (IC) | Change in IC from baseline to end of treatment | Before treatment and after 1, 2, 4 and 6 weeks of treatment | 
| Forced Expiratory Flow (FEF)25-75% | Change in FEF from baseline to end of treatment | Before treatment and after 1, 2, 4 and 6 weeks of treatment | 
| Peak Expiratory Flow (PEF) Morning | Change in PEF from average during run-in to average during the last 4 w of treatment | Daily during run-in and treatment | 
| Peak Expiratory Flow (PEF) Evening | Change in PEF from average during run-in to average during the last 4 w of treatment | Daily during run-in and treatment | 
| Clinical Chronic Obstructive Pulmonary Disease (COPD) 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, 4 and 6 weeks of treatment | 
| Clinical Chronic Obstructive Pulmonary Disease (COPD) Symptoms, Breathlessness | Change in COPD symptom, Breathlessness from average during run-in to average during the last 4 w of treatment. 5-point Likert-type scale, ranging from 0 (none) to 4 (severe) | Daily during run-in and treatment | 
| Clinical Chronic Obstructive Pulmonary Disease (COPD) Symptoms, Chest Tightness | Change in COPD symptom, chest tightness from average during run-in to average during the last 4 w of treatment, 5-point Likert-type scale, ranging from 0 (none) to 4 (severe) | Daily during run-in and treatment | 
| Clinical Chronic Obstructive Pulmonary Disease (COPD) Symptoms, Cough Score | Change in COPD symptoms, cough score from average during run-in to average during the last 4 w of treatment, 5-point Likert-type scale, ranging from 0 (none) to 4 (severe) | Daily during run-in and treatment | 
| Clinical Chronic Obstructive Pulmonary Disease (COPD) Symptoms, Night Time Awakenings | Change in night time awakenings from average during run-in to average during the last 4 w of treatment, 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 6 weeks of treatment | 

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