A Single-dose Study to Investigate the Effects of 3 Different Doses of Inhaled AZD2115 in COPD Patients

Phase 2

Completed

• Conditions: COPD
• Interventions: Drug: AZD2115; Drug: Placebo; Drug: Indacaterol; Drug: Indacaterol + Tiotropium

• Registration Number: NCT01498081
• Lead Sponsor: AstraZeneca

Brief Summary

This study in COPD patients will investigate the bronchodilatory effect of AZD2115. AZD2115 will be tested versus placebo and active comparators. The safety and tolerability of AZD2115 including investigations of clinically relevant systemically mediated effects will also be investigated.

Detailed Description

A randomised, double-blind, placebo and active controlled, multi-centre, 6 way cross-over, single-dose Phase IIa study to investigate the local and systemic effects of 3 different doses of inhaled AZD2115 in patients with chronic obstructive pulmonary disease (COPD)

Study Timeline

• Study First Submitted: 2011-12-21
• Study First Submitted QC: 2011-12-21
• Study First Posted: 2011-12-23
• Study Start: 2012-03
• Status Verified: 2012-10
• Primary Completion: 2012-10
• Study Completion: 2012-10
• Last Update Submitted: 2012-10-25
• Last Update Posted: 2012-10-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39

Inclusion Criteria

• Provision of informed consent prior to any study specific procedures
• Male or female of non-childbearing potential (post-menopausal or surgically sterilised), age ≥40 years at Visit 1
• Clinical diagnosis of COPD for more than 1 year at Visit 1, according to GOLD guidelines
• Post-bronchodilator FEV1 ≥ 40 to < 80% of the predicted normal value 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 within 6 weeks prior to Visit 1
• Treatment with systemic glucocorticosteroids with 6 weeks of Visit 2.
• Recent or ongoing respiratory tract infection during enrolment period.
• Need for long-term oxygen therapy and/or saturation O2 < 92%.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Single dose of AZD2115 240 µg	AZD2115	-
Single doses of placebo	Placebo	-
Single dose of indacaterol 150 µg	Indacaterol	-
Single dose of AZD2115 25 µg	AZD2115	-
Single dose of AZD2115 80 µg	AZD2115	-
Single dose of indacaterol 150 µg + tiotropium 18 µg	Indacaterol + Tiotropium	-

Primary Outcome Measures

Name	Time	Method
Peak Forced Expiratory Volume in 1 second (FEV1) defined as the maximum FEV1 from the spirometry assessments	During the first 24 hours following administration
Trough FEV1defined as the average FEV1 from the spirometry assessments	During 22 to 26 hours following administration

Secondary Outcome Measures

Name	Time	Method
Average FEV1	FEV1 0-24h post-dose
Peak, average and trough Forced Vital Capacity (FVC)	FVC peak and average 0-24h post-dose and trough 22-26h post-dose
Systemic effect by assessment of blood pressure (BP)	Peak and average 0-4 h post dose
Systemic effect by assessment of heart rate (HR) and QT interval corrected for heart rate using Fridericia's formula (QTcF)	Peak and average 0-4 h post dose
Systemic effect by assessment of Potassium and Glucose	Peak and average 0-4 h post dose
Safety and tolerability of 3 different single doses of AZD2115	At screening, during 0-26 h post-dose and at follow-up
Plasma concentrations of AZD2115 after 3 different single doses measured as area under the curve over the time (AUC) and maximum concentration (Cmax), and time to maximum concentration (tmax)	0-24h post dose

Trial Locations

Locations (1)

Research Site; 🇸🇪 Lund, Sweden