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

AstraZeneca

Status and phase: Completed; Phase 2

Conditions: COPD

Treatments: Drug: AZD2115; Drug: Indacaterol; Drug: Indacaterol + Tiotropium; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01498081

EudraCT number: 2011-004641-41

D3060C00003

Details and patient eligibility

About

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.

Full 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)

Enrollment: 39 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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%.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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39 participants in 6 patient groups, including a placebo group

Single dose of AZD2115 25 µg

Experimental group

Treatment:

Drug: AZD2115

Single dose of AZD2115 80 µg

Experimental group

Treatment:

Drug: AZD2115

Single dose of AZD2115 240 µg

Experimental group

Treatment:

Drug: AZD2115

Single doses of placebo

Placebo Comparator group

Treatment:

Drug: Placebo

Single dose of indacaterol 150 µg

Active Comparator group

Treatment:

Drug: Indacaterol

Single dose of indacaterol 150 µg + tiotropium 18 µg

Active Comparator group

Treatment:

Drug: Indacaterol + Tiotropium