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)
Overview
- Phase
- Phase 2
- Intervention
- AZD8683
- Conditions
- Chronic Obstructive Pulmonary Disease
- Sponsor
- AstraZeneca
- Enrollment
- 3
- Primary Endpoint
- Change From Baseline in Peak FEV1 (0-24h)
- Status
- Terminated
- Last Updated
- 12 years ago
Overview
Brief Summary
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
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).
Investigators
Eligibility Criteria
Inclusion Criteria
- •Provision of informed consent prior to any study specific procedures Male or female, age ≥ 40 years at Visit
- •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
Arms & Interventions
1
Single dose of AZD8683 50 µg
Intervention: AZD8683
2
Single dose of AZD8683 150 µg
Intervention: AZD8683
3
Single dose of AZD8683 300 µg
Intervention: AZD8683
4
Single dose of AZD8683 900 µg
Intervention: AZD8683
5
Single dose of placebo
Intervention: Placebo
6
Single dose of tiotropium 18 µg
Intervention: Tiotropium
Outcomes
Primary Outcomes
Change From Baseline in Peak FEV1 (0-24h)
Time Frame: The first 24 hours following dose administration
The maximum value over 24 hours post-dose, as change from baseline
Change From Baseline in Trough FEV1 (22-26h)
Time Frame: 22 to 26 hours following dose administration
The average over 22 to 26 hours, as change from baseline
Secondary Outcomes
- Maximum Increase in Systolic Blood Pressure [SBP](baseline, 24hr post dose)
- PK Parameters (AZD8683)(Pre-dose, 24hr post-dose)
- Average FEV1 as a Change From Baseline(The first 24 hours following dose administration)
- Maximum Increase in Diastolic Blood Pressure [DBP](The first 24 hours following dose administration)
- Maximum Increase Heart Rate [HR](baseline, 24hr post dose)
- Maximum Increase in QTcF(baseline, 24hr post dose)