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

Overview

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.

Full Title of Study: “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)”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: December 2012

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).

Interventions

  • Drug: AZD8683
    • AZD8683 administered via inhalation
  • Drug: Placebo
    • Placebo administered via inhalation
  • Drug: Tiotropium
    • Tiotropium administered via inhalation

Arms, Groups and Cohorts

  • Experimental: 1
    • Single dose of AZD8683 50 µg
  • Experimental: 2
    • Single dose of AZD8683 150 µg
  • Experimental: 3
    • Single dose of AZD8683 300 µg
  • Experimental: 4
    • Single dose of AZD8683 900 µg
  • Placebo Comparator: 5
    • Single dose of placebo
  • Active Comparator: 6
    • Single dose of tiotropium 18 µg

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 40 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • AstraZeneca
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Carin Jorup, MD, Study Director, AstraZeneca R&DMolndal, Sweden

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