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

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01708057
• Other study ID #: D1883C00007
• Secondary ID: EudraCT number:
• Status: Terminated
• Phase: Phase 2
• First received: October 1, 2012
• Last updated: December 13, 2013
• Start date: October 2012
• Est. completion date: December 2012

Study information

• Verified date: December 2013
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products AgencyPoland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• COPD
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

Poland,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	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	No
Secondary	Maximum Increase in Systolic Blood Pressure [SBP]	Maximum (post-dose values - baseline value) for each treatment visit.	baseline, 24hr post dose	No
Secondary	Maximum Increase in Diastolic Blood Pressure [DBP]	Maximum (post-dose values - baseline value) for each treatment visit.	The first 24 hours following dose administration	No
Secondary	Maximum Increase Heart Rate [HR]	Maximum (post-dose values - baseline value) for each treatment visit.	baseline, 24hr post dose	No
Secondary	Maximum Increase in QTcF	maximum (post-dose values - baseline value) for each treatment visit.	baseline, 24hr post dose	No
Secondary	PK Parameters (AZD8683)	Cmax, tmax, AUC	Pre-dose, 24hr post-dose	No