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

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)

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.

Study Overview

• Status: Completed
• Conditions: COPD
• Intervention / Treatment: Drug: AZD2115; Drug: Placebo; Drug: Indacaterol; Drug: Indacaterol + Tiotropium

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 Type: Interventional
• Enrollment (Actual): 39
• Phase: Phase 2

Contacts and Locations

Study Locations

• Poland
  • Bialystok, Poland
    • Research Site
  • Leczna, Poland
    • Research Site
  • Lodz, Poland
    • Research Site
  • Proszowice, Poland
    • Research Site
• Sweden
  • Goteborg, Sweden
    • Research Site
  • Lund, Sweden
    • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: DOUBLE

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Single dose of AZD2115 25 µg	Drug: AZD2115; AZD2115 administered via inhalation
EXPERIMENTAL: Single dose of AZD2115 80 µg	Drug: AZD2115; AZD2115 administered via inhalation
EXPERIMENTAL: Single dose of AZD2115 240 µg	Drug: AZD2115; AZD2115 administered via inhalation
PLACEBO_COMPARATOR: Single doses of placebo	Drug: Placebo; Placebo administered via inhalation
ACTIVE_COMPARATOR: Single dose of indacaterol 150 µg	Drug: Indacaterol; Indacaterol administered via inhalation
ACTIVE_COMPARATOR: Single dose of indacaterol 150 µg + tiotropium 18 µg	Drug: Indacaterol + Tiotropium; Indacaterol + Tiotropium administered inhalation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: AstraZeneca
• Investigators: Study Director: Carin Jorup, MD, AstraZeneca R&D Mölndal, Sweden

Study record dates

Study Major Dates

• Study Start: March 1, 2012
• Primary Completion (ACTUAL): October 1, 2012
• Study Completion (ACTUAL): October 1, 2012

Study Registration Dates

• First Submitted: December 21, 2011
• First Submitted That Met QC Criteria: December 21, 2011
• First Posted (ESTIMATE): December 23, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): October 26, 2012
• Last Update Submitted That Met QC Criteria: October 25, 2012
• Last Verified: October 1, 2012

More Information

Terms related to this study

• Keywords: COPD, pulmonary disease
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Parasympatholytics; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Antagonists; Cholinergic Agents; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Tiotropium Bromide
• Other Study ID Numbers: D3060C00003; EudraCT number: 2011-004641-41