The Study Will Evaluate the Effect of AZD8683 in Patients With Chronic Obstructive Pulmonary Disease (COPD)

Study Overview
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Brief Summary
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The purpose of this study is to investigate effects of inhaled AZD8683 compared to placebo in COPD patients.

Detailed Description
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A double-blind, placebo-controlled, randomised, multi-centre, 3-way cross-over, single-dose phase II study to investigate the local and systemic effects of inhaled AZD8683 in patients with chronic obstructive pulmonary disease (COPD)

Official Title
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A Double-blind, Placebo-controlled, Randomised, Multi-centre, 3-way Cross-over, Single-dose Phase II Study to Investigate the Local and Systemic Effects of Inhaled AZD8683 in Patients With Chronic Obstructive Pulmonary Disease (COPD)

Conditions
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Chronic Obstructive Pulmonary Disease (COPD)

Intervention / Treatment
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* Drug: AZD8683, 50 mcg
* Drug: Placebo
* Drug: AZD8683, 200 mcg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical diagnosis of COPD Current or ex-smokers FEV1 40 - 80% of the predicted normal value (post-bronchodilator) and post-bronchodilator FEV1/FVC < 70% Exclusion Criteria: Any clinically significant disease or disorder Any clinically relevant abnormal findings at screening examinations Family history or presence of glaucoma Need of long term oxygen therapy

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: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: First 50 mcg, then 200 mcg, then placebo<br>period 1: AZD8683 50 mcg, period 2: washout, period 3: AZD8683 200 mcg, period 4:washout, period5: placebo | Drug: AZD8683, 50 mcg<br>* Dry powder for inhalation, single dose<br>Drug: Placebo<br>* Dry powder for inhalation, single dose<br>Drug: AZD8683, 200 mcg<br>* Dry powder for inhalation, single dose<br>|
| Experimental: First 50 mcg, then placebo, then 200 mcg<br>period 1: AZD8683 50 mcg, period 2: washout, period 3: placebo, period 4: washout, period5:AZD8683 200 mcg | Drug: AZD8683, 50 mcg<br>* Dry powder for inhalation, single dose<br>Drug: Placebo<br>* Dry powder for inhalation, single dose<br>Drug: AZD8683, 200 mcg<br>* Dry powder for inhalation, single dose<br>|
| Experimental: First 200 mcg, then placebo, then 50 mcg<br>period 1: AZD8683 200 mcg, period 2: washout, period 3: placebo, period 4: washout, period 5: AZD8683 50 mcg | Drug: AZD8683, 50 mcg<br>* Dry powder for inhalation, single dose<br>Drug: Placebo<br>* Dry powder for inhalation, single dose<br>Drug: AZD8683, 200 mcg<br>* Dry powder for inhalation, single dose<br>|
| Experimental: First 200 mcg, then 50 mcg, then placebo<br>period 1: AZD8683 200 mcg, period 2: washout, period 3: AZD8683 50 mcg, period 4: washout, period 5: placebo | Drug: AZD8683, 50 mcg<br>* Dry powder for inhalation, single dose<br>Drug: Placebo<br>* Dry powder for inhalation, single dose<br>Drug: AZD8683, 200 mcg<br>* Dry powder for inhalation, single dose<br>|
| Experimental: First placebo, then 200 mcg, then 50 mcg<br>period 1: placebo , period 2: washout, period 3: AZD8683 200 mcg, period 4: washout, period5: AZD8683 50 mcg | Drug: AZD8683, 50 mcg<br>* Dry powder for inhalation, single dose<br>Drug: Placebo<br>* Dry powder for inhalation, single dose<br>Drug: AZD8683, 200 mcg<br>* Dry powder for inhalation, single dose<br>|
| Experimental: First placebo, then 50 mcg, then 200 mcg<br>period 1: placebo , period 2: washout, period 3: AZD8683 50 mcg, period 4: washout, period5: AZD8683 200 mcg | Drug: AZD8683, 50 mcg<br>* Dry powder for inhalation, single dose<br>Drug: Placebo<br>* Dry powder for inhalation, single dose<br>Drug: AZD8683, 200 mcg<br>* Dry powder for inhalation, single dose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Forced Expiratory Volume in One Second (FEV1), Peak Effect Within 0 - 24 Hours Post-dose | Maximum FEV1 value | 0, 5 min, 15 min, 30 min, 1 h, 2 h, 4 h, 6 h, 8 h, 10 h, 12 h, 14 h, 18 h, 22 h, 24 h | 
| Forced Expiratory Volume in One Second (FEV1), Average Effect Over 22 - 26 Hours Post-dose | Trough FEV1 value | 22 h, 24 h, 26 h | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Forced Expiratory Volume in One Second (FEV1), Average Effect Over 0 - 24 Hours Post-dose | Average FEV1 value | 0, 5 min, 15 min, 30 min, 1 h, 2 h, 4 h, 6 h, 8 h, 10 h, 12 h, 14 h, 18 h, 22 h, 24 h | 
| Forced Vital Capacity (FVC), Peak Effect Over 0 - 24 Hours Post-dose | Maximum FVC value | 0, 5 min, 15 min, 30 min, 1 h, 2 h, 4 h, 6 h, 8 h, 10 h, 12 h, 14 h, 18 h, 22 h, 24 h | 
| Systolic Blood Pressure, Average Effect Over 0 - 4 Hours Post-dose | Average systolic blood pressure value | 0, 30 min, 2 h, 4 h | 
| Diastolic Blood Pressure, Average Effect Over 0 - 4 Hours Post-dose | Average diastolic blood pressure value | 0, 30 min, 2 h, 4 h | 
| Pulse, Average Effect Over 0 - 4 Hours Post-dose | Average pulse value | 0, 30 min, 2 h, 4 h | 
| Heart Rate, Average Effect Over 0 - 4 Hours Post-dose | Average heart rate value | 0, 30 min, 2 h, 4 h | 
| QTcF, Average Effect Over 0 - 4 Hours Post-dose | Average QTcF value. QTcF = QT interval corrected for heart rate using Fridericia's formula | 0, 30 min, 2 h, 4 h | 
| Plasma AZD8683 Cmax | Maximum plasma concentration of AZD8683 | 0, 5 min, 15 min, 30 min, 45 min, 1 h, 90 min, 2 h, 4 h, 6 h, 8 h, 12 h, 24 h | 
| Plasma AZD8683 AUC0-24 | Area under the AZD8683 plasma concentration curve from 0 to 24 hours | 0, 5 min, 15 min, 30 min, 45 min, 1 h, 90 min, 2 h, 4 h, 6 h, 8 h, 12 h, 24 h | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic Obstructive Pulmonary Disease (COPD), safety, inhalation, long-acting muscarinic receptor antagonist (LAMA)