A Single-dose Study to Investigate the Effects of 4 Different Doses of Inhaled AZD8683 in Chronic Obstructive Pulmonary Disease (COPD) Patients

Study Overview
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Brief Summary
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This study in Chronic Obstructive Pulmonary Disease (COPD) patients will investigate the bronchodilatory effect of AZD8683. AZD8683 will be tested versus placebo and an active comparator.

Detailed Description
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A randomised, double-blind placebo- and active-controlled, multi-centre, 6-way cross-over, single-dose phase IIa study to investigate the bronchodilatory and systemic effects of 4 different doses of inhaled AZD8683 in patients with Chronic Obstructive Pulmonary Disease (COPD).

Official Title
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A Randomised, Double-blind Placebo- and Active-controlled, Multi-centre, 6-way Cross-over, Single-dose Phase IIa Study to Investigate the Bronchodilatory and Systemic Effects of 4 Different Doses 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
* Drug: Placebo
* Drug: Tiotropium


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Provision of informed consent prior to any study specific procedures Male or female, age ≥ 40 years at Visit 1. Women must be of non-childbearing potential or must have been stable on a highly effective contraceptive method for at least 3 months prior to Visit 1 and be willing to continue until follow-up Clinical diagnosis of COPD for more than 1 year at Visit 1 FEV1 ≥ 30 to < 80% of the predicted normal value (post-bronchodilator) at Visit 2 and post-bronchodilator FEV1/FVC < 70% Reversible airway obstruction Exclusion Criteria: Significant disease or disorder which, in the opinion of the Investigator, may either put the patient at risk because of participation in the study, or influence the result of the study, or the patient's ability to participate in the study. An exacerbation of COPD (defined as use of oral/parenteral glucocorticosteroids (GCS) and/or antibiotics and/or hospitalisation related to COPD) within 6 weeks of Visit 1or during the enrolment period Treatment with systemic GCS within 6 weeks of Visit 2 or during the enrolment period Respiratory tract infection of clinical relevance within 30 days of Visit 4, as judged by the Investigator Long-term oxygen therapy, as judged by the Investigator

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Single dose of AZD8683 50 µg | Drug: AZD8683<br>* AZD8683 administered via inhalation<br>|
| Experimental: 2<br>Single dose of AZD8683 150 µg | Drug: AZD8683<br>* AZD8683 administered via inhalation<br>|
| Experimental: 3<br>Single dose of AZD8683 300 µg | Drug: AZD8683<br>* AZD8683 administered via inhalation<br>|
| Experimental: 4<br>Single dose of AZD8683 900 µg | Drug: AZD8683<br>* AZD8683 administered via inhalation<br>|
| Placebo Comparator: 5<br>Single dose of placebo | Drug: Placebo<br>* Placebo administered via inhalation<br>|
| Active Comparator: 6<br>Single dose of tiotropium 18 µg | Drug: Tiotropium<br>* Tiotropium administered via inhalation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Peak FEV1 (0-24h) | The maximum value over 24 hours post-dose, as change from baseline | The first 24 hours following dose administration | 
| Change From Baseline in Trough FEV1 (22-26h) | The average over 22 to 26 hours, as change from baseline | 22 to 26 hours following dose administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average FEV1 as a Change From Baseline | Average FEV1 (0-24h): The average over 0 to 24 hours | The first 24 hours following dose administration | 
| Maximum Increase in Systolic Blood Pressure [SBP] | Maximum (post-dose values - baseline value) for each treatment visit. | baseline, 24hr post dose | 
| Maximum Increase in Diastolic Blood Pressure [DBP] | Maximum (post-dose values - baseline value) for each treatment visit. | The first 24 hours following dose administration | 
| Maximum Increase Heart Rate [HR] | Maximum (post-dose values - baseline value) for each treatment visit. | baseline, 24hr post dose | 
| Maximum Increase in QTcF | maximum (post-dose values - baseline value) for each treatment visit. | baseline, 24hr post dose | 
| PK Parameters (AZD8683) | Cmax, tmax, AUC | Pre-dose, 24hr post-dose | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COPD, Chronic obstructive pulmonary disease