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A Single-dose Study to Investigate the Effects of 3 Different Doses of Inhaled AZD2115 in COPD Patients | Clinical Trials | Clareo Health

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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)

NCT01498081•AstraZeneca

View on ClinicalTrials.gov

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)

Eligibility

Age

40 - No limit years

Sex

ALL

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%.

Locations (6)

Research Site

Bialystok, Poland

Research Site

Lodz, Poland

Research Site

Proszowice, Poland

Research Site

Łęczna, Poland

Research Site

Gothenburg, Sweden

Research Site

Lund, Sweden

Key Dates

Start Date

March 1, 2012

Primary Completion Date

October 1, 2012

Completion Date

October 1, 2012

Last Updated

October 26, 2012

Enrollment

ACTUAL participants

Conditions

COPD

Interventions

AZD2115

DRUG

Placebo

DRUG

Indacaterol

DRUG

Indacaterol + Tiotropium

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 26, 2012Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

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