Clinical trial NCT01708057: A Single-dose Study to Investigate the Effects of 4 Different Doses of Inhaled AZD8683 in Chronic Obstructive Pulmonary Disease (COPD) Patients
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)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Chronic Obstructive Pulmonary Disease
COPD
Keywords: COPD
Chronic obstructive pulmonary disease
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2012-10-16
Enrollment: 3
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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).

Eligibility criteria: 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

Primary outcomes:
measure: Change From Baseline in Peak FEV1 (0-24h)
timeFrame: The first 24 hours following dose administration
measure: Change From Baseline in Trough FEV1 (22-26h)
timeFrame: 22 to 26 hours following dose administration
Secondary outcomes:
measure: Average FEV1 as a Change From Baseline
timeFrame: The first 24 hours following dose administration
measure: Maximum Increase in Systolic Blood Pressure [SBP]
timeFrame: baseline, 24hr post dose
measure: Maximum Increase in Diastolic Blood Pressure [DBP]
timeFrame: The first 24 hours following dose administration
measure: Maximum Increase Heart Rate [HR]
timeFrame: baseline, 24hr post dose
measure: Maximum Increase in QTcF
timeFrame: baseline, 24hr post dose
measure: PK Parameters (AZD8683)
timeFrame: Pre-dose, 24hr post-dose
Other outcomes:
Locations:
city: Bialystok
country: Poland
city: Lodz
country: Poland
city: Proszowice
country: Poland
city: Wroclaw
country: Poland
city: Goteborg
country: Sweden
city: Lund
country: Sweden
Study officials:
affiliation: AstraZeneca R&DMolndal, Sweden
name: Carin Jorup, MD
role: STUDY_DIRECTOR
References: