Efficacy of AZD3199 in Chronic Obstructive Pulmonary Disease (COPD) Patients

Study Overview
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Brief Summary
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The purpose of this study is to investigate the efficacy, safety and tolerability of 4 weeks treatment with AZD3199 in moderate to severe COPD.

Official Title
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A 4-week, Phase-II, Double-blind, Placebo-controlled, Randomised, Parallel-group, Multi-centre Study to Assess the Efficacy and Tolerability/Safety of Inhaled AZD3199 Once Daily Compared to 9 μg Formoterol Bid and Placebo in Patients With Moderate to Severe COPD

Conditions
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COPD

Intervention / Treatment
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* Drug: AZD3199
* Drug: formoterol
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: COPD Current or exsmokers, 10 pack years Exclusion Criteria: Asthma Any clinically relevant abnormal findings at screening examinations Recent COPD exacerbation

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>AZD3199 low dose | Drug: AZD3199<br>* Dry powder for inhalation, o.d., 4 weeks<br>|
| Experimental: 2<br>AZD3199 intermediate dose | Drug: AZD3199<br>* Dry powder for inhalation, o.d., 4 weeks<br>|
| Experimental: 3<br>AZD3199 high dose | Drug: AZD3199<br>* Dry powder for inhalation, o.d., 4 weeks<br>|
| Active Comparator: 4<br>Formoterol 2x4.5 microgram bid | Drug: formoterol<br>* Dry powder for inhalation, b.i.d., 4 weeks<br>|
| Placebo Comparator: 5<br>Placebo | Drug: Placebo<br>* Dry powder for inhalation, b.i.d., 4 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| FEV1, E0-4; the Average Value at Visit 5 From Before to 4 Hours After Morning Dose (Peak Effect) | change from baseline | 0,5 min, 15 min, 60 min, 2 h, 4 h | 
| FEV1, E24-26; the Average Value at Visit 5 Between 24 and 26 Hours Following the Morning Dose (Trough Effect) | change from baseline | 24h, 26h | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax; the Highest Plasma Concentration of AZD3199 Measured | PK is only measured for AZD3199 | 0,15 min, 1, 4 and 24 hours post dose | 
| AUC0-24; Area Under the Plasma Concentration Curve From Zero to 24 Hours After Dose | PK is only measured for AZD3199 | 0,15 min, 1, 4 and 24 hours post dose | 
| FEV1 Post Salbutamol Inhalation | Mean value of FEV1 pre and post salbutamol at visit 2 and visit 5 | Baseline (visit 2) and 26 h after the last morning dose (visit 5). | 
| Total Number of Reliever Medication Inhalations Per 24h | Change from run-in | During day (from rising from bed until going to bed) and night (from going to bed until rising from bed) at visit 1 to visit 5 (24h), up to 4 weeks. | 
| Total AstraZeneca COPD Symptoms Scores (Included Breathlessness, Chest Tightness, Cough and Night-time Awakenings) | Score on a scale 5-point Likert-type scale, ranging from 0 (none) to 4 (severe) for each symptom, total score is the sum of each symptom ranged from 0 to 16. Change from run-in. | Daily, during run-in and treatment | 
| Overall Mean CCQ (Clinical COPD Questionnaire) | Change from baseline to treatment in score. The total scores vary between 0 (never/not limited at all) to 6 (almost all the time/totally limited). The data below represent the average of week 1,2,4 minus week 0. | Mean over week 0, mean over week 1, mean over week 2, and mean over week 4 | 
| Total Score SGRQ-C (St George's Respiratory Questionnaire for COPD) | The total score is calculated using all questions including their weights and scores range from 0 (perfect health) to 100 (worst possible state) | At baseline (visit 2) and after 4 weeks of treatment (visit 5). | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COPD, Efficacy, Safety, Inhalation