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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


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
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