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

NCT ID: NCT01498081

Last Updated: 2012-10-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2012-10-31

Brief Summary

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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

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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)

Conditions

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COPD

Keywords

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COPD, pulmonary disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Single dose of AZD2115 25 µg

Group Type EXPERIMENTAL

AZD2115

Intervention Type DRUG

AZD2115 administered via inhalation

Single dose of AZD2115 80 µg

Group Type EXPERIMENTAL

AZD2115

Intervention Type DRUG

AZD2115 administered via inhalation

Single dose of AZD2115 240 µg

Group Type EXPERIMENTAL

AZD2115

Intervention Type DRUG

AZD2115 administered via inhalation

Single doses of placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo administered via inhalation

Single dose of indacaterol 150 µg

Group Type ACTIVE_COMPARATOR

Indacaterol

Intervention Type DRUG

Indacaterol administered via inhalation

Single dose of indacaterol 150 µg + tiotropium 18 µg

Group Type ACTIVE_COMPARATOR

Indacaterol + Tiotropium

Intervention Type DRUG

Indacaterol + Tiotropium administered inhalation

Interventions

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AZD2115

AZD2115 administered via inhalation

Intervention Type DRUG

Placebo

Placebo administered via inhalation

Intervention Type DRUG

Indacaterol

Indacaterol administered via inhalation

Intervention Type DRUG

Indacaterol + Tiotropium

Indacaterol + Tiotropium administered inhalation

Intervention Type DRUG

Eligibility Criteria

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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%.
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Carin Jorup, MD

Role: STUDY_DIRECTOR

AstraZeneca R&D Molndal, Sweden

Locations

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Research Site

Bialystok, , Poland

Site Status

Research Site

Lodz, , Poland

Site Status

Research Site

Proszowice, , Poland

Site Status

Research Site

Łęczna, , Poland

Site Status

Research Site

Gothenburg, , Sweden

Site Status

Research Site

Lund, , Sweden

Site Status

Countries

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Poland Sweden

Other Identifiers

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EudraCT number: 2011-004641-41

Identifier Type: -

Identifier Source: secondary_id

D3060C00003

Identifier Type: -

Identifier Source: org_study_id