A Single-dose Study to Investigate the Effects of 3 Different Doses of Inhaled AZD2115 in COPD Patients

Study Overview
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Brief Summary
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This study in COPD patients will investigate the bronchodilatory effect of AZD2115. AZD2115 will be tested versus placebo and active comparators. The safety and tolerability of AZD2115 including investigations of clinically relevant systemically mediated effects will also be investigated.

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 local and systemic effects of 3 different doses of inhaled AZD2115 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 Local and Systemic Effects of 3 Different Doses of Inhaled AZD2115 in Patients With Chronic Obstructive Pulmonary Disease (COPD)

Conditions
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COPD

Intervention / Treatment
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* Drug: AZD2115
* Drug: Placebo
* Drug: Indacaterol
* Drug: Indacaterol + 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 of non-childbearing potential (post-menopausal or surgically sterilised), age ≥40 years at Visit 1 Clinical diagnosis of COPD for more than 1 year at Visit 1, according to GOLD guidelines Post-bronchodilator FEV1 ≥ 40 to < 80% of the predicted normal value 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 within 6 weeks prior to Visit 1 Treatment with systemic glucocorticosteroids with 6 weeks of Visit 2. Recent or ongoing respiratory tract infection during enrolment period. Need for long-term oxygen therapy and/or saturation O2 < 92%.

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: Single dose of AZD2115 25 µg<br> | Drug: AZD2115<br>* AZD2115 administered via inhalation<br>|
| Experimental: Single dose of AZD2115 80 µg<br> | Drug: AZD2115<br>* AZD2115 administered via inhalation<br>|
| Experimental: Single dose of AZD2115 240 µg<br> | Drug: AZD2115<br>* AZD2115 administered via inhalation<br>|
| Placebo Comparator: Single doses of placebo<br> | Drug: Placebo<br>* Placebo administered via inhalation<br>|
| Active Comparator: Single dose of indacaterol 150 µg<br> | Drug: Indacaterol<br>* Indacaterol administered via inhalation<br>|
| Active Comparator: Single dose of indacaterol 150 µg + tiotropium 18 µg<br> | Drug: Indacaterol + Tiotropium<br>* Indacaterol + Tiotropium administered inhalation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peak Forced Expiratory Volume in 1 second (FEV1) defined as the maximum FEV1 from the spirometry assessments |  | During the first 24 hours following administration | 
| Trough FEV1defined as the average FEV1 from the spirometry assessments |  | During 22 to 26 hours following administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average FEV1 |  | FEV1 0-24h post-dose | 
| Peak, average and trough Forced Vital Capacity (FVC) |  | FVC peak and average 0-24h post-dose and trough 22-26h post-dose | 
| Systemic effect by assessment of blood pressure (BP) |  | Peak and average 0-4 h post dose | 
| Systemic effect by assessment of heart rate (HR) and QT interval corrected for heart rate using Fridericia's formula (QTcF) |  | Peak and average 0-4 h post dose | 
| Systemic effect by assessment of Potassium and Glucose |  | Peak and average 0-4 h post dose | 
| Safety and tolerability of 3 different single doses of AZD2115 |  | At screening, during 0-26 h post-dose and at follow-up | 
| Plasma concentrations of AZD2115 after 3 different single doses measured as area under the curve over the time (AUC) and maximum concentration (Cmax), and time to maximum concentration (tmax) |  | 0-24h post dose | 

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