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

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)

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.

Study Overview

• Status: Terminated
• Conditions: Chronic Obstructive Pulmonary Disease; COPD
• Intervention / Treatment: Drug: Placebo; Drug: AZD8683; Drug: Tiotropium

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).

• Study Type: Interventional
• Enrollment (Actual): 3
• Phase: Phase 2

Contacts and Locations

Study Locations

• Poland
  • Bialystok, Poland
  • Lodz, Poland
  • Proszowice, Poland
  • Wroclaw, Poland
• Sweden
  • Goteborg, Sweden
  • Lund, Sweden

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

6

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: AstraZeneca
• Investigators: Study Director: Carin Jorup, MD, AstraZeneca R&DMolndal, Sweden

Study record dates

Study Major Dates

• Study Start: October 1, 2012
• Primary Completion (Actual): December 1, 2012
• Study Completion (Actual): December 1, 2012

Study Registration Dates

• First Submitted: October 1, 2012
• First Submitted That Met QC Criteria: October 15, 2012
• First Posted (Estimate): October 16, 2012

Study Record Updates

• Last Update Posted (Estimate): January 15, 2014
• Last Update Submitted That Met QC Criteria: December 13, 2013
• Last Verified: December 1, 2013

More Information

Terms related to this study

• Keywords: COPD; Chronic obstructive pulmonary disease
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Parasympatholytics; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Antagonists; Cholinergic Agents; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Tiotropium Bromide
• Other Study ID Numbers: D1883C00007; EudraCT number: 2012-002900-42