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Efficacy of AZD3199 in Chronic Obstructive Pulmonary Disease (COPD) Patients

NCT ID: NCT00929708

Last Updated: 2014-02-17

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

329 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-30

Study Completion Date

2010-03-31

Brief Summary

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The purpose of this study is to investigate the efficacy, safety and tolerability of 4 weeks treatment with AZD3199 in moderate to severe COPD.

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Detailed Description

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Conditions

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COPD

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

AZD3199 low dose

Group Type EXPERIMENTAL

AZD3199

Intervention Type DRUG

Dry powder for inhalation, o.d., 4 weeks

2

AZD3199 intermediate dose

Group Type EXPERIMENTAL

AZD3199

Intervention Type DRUG

Dry powder for inhalation, o.d., 4 weeks

3

AZD3199 high dose

Group Type EXPERIMENTAL

AZD3199

Intervention Type DRUG

Dry powder for inhalation, o.d., 4 weeks

4

Formoterol 2x4.5 microgram bid

Group Type ACTIVE_COMPARATOR

formoterol

Intervention Type DRUG

Dry powder for inhalation, b.i.d., 4 weeks

5

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Dry powder for inhalation, b.i.d., 4 weeks

Interventions

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AZD3199

Dry powder for inhalation, o.d., 4 weeks

Intervention Type DRUG

formoterol

Dry powder for inhalation, b.i.d., 4 weeks

Intervention Type DRUG

Placebo

Dry powder for inhalation, b.i.d., 4 weeks

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* COPD
* Current or exsmokers, 10 pack years

Exclusion Criteria

* Asthma
* Any clinically relevant abnormal findings at screening examinations
* Recent COPD exacerbation
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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Piotr Kuna, Professor

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Lodz, Poland

Locations

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Research Site

Blagoevgrad, , Bulgaria

Site Status

Research Site

Pleven, , Bulgaria

Site Status

Research Site

Rousse, , Bulgaria

Site Status

Research Site

Sofia, , Bulgaria

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Varna, , Bulgaria

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Moncton, New Brunswick, Canada

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Research Site

St. John's, Newfoundland and Labrador, Canada

Site Status

Research Site

Truro, Nova Scotia, Canada

Site Status

Research Site

Greater Sudbury, Ontario, Canada

Site Status

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Mississauga, Ontario, Canada

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Toronto, Ontario, Canada

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Pointe-Claire, Quebec, Canada

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Saint Romuald, Quebec, Canada

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Trois-Rivières, Quebec, Canada

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Research Site

Yanagawa, Fukuoka, Japan

Site Status

Research Site

Fukuyama, Hiroshima, Japan

Site Status

Research Site

Chitose, Hokkaido, Japan

Site Status

Research Site

Obihiro, Hokkaido, Japan

Site Status

Research Site

Tomakomai, Hokkaido, Japan

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Hitachi, Ibaragi, Japan

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Naka-gun, Ibaraki, Japan

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Sendai, Miyagi, Japan

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Osaka, Osaka, Japan

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Toyonaka, Osaka, Japan

Site Status

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Moriyama, Shiga, Japan

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Ōtsu, Shiga, Japan

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Machida, Tokyo, Japan

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Research Site

Kitakyushu, , Japan

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Research Site

Bialystok, , Poland

Site Status

Research Site

Gorzow Wlkp, , Poland

Site Status

Research Site

Lodz, , Poland

Site Status

Research Site

Lublin, , Poland

Site Status

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Poznan, , Poland

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Szczecin, , Poland

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Tarnów, , Poland

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Research Site

Moscow, , Russia

Site Status

Research Site

Novosibirsk, , Russia

Site Status

Research Site

Saint Petersburg, , Russia

Site Status

Countries

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Bulgaria Canada Japan Poland Russia

References

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Kuna P, Ivanov Y, Trofimov VI, Saito T, Beckman O, Bengtsson T, Jorup C, Maltais F. Efficacy and safety of AZD3199 vs formoterol in COPD: a randomized, double-blind study. Respir Res. 2013 Jun 3;14(1):64. doi: 10.1186/1465-9921-14-64.

Reference Type DERIVED
PMID: 23731768 (View on PubMed)

Other Identifiers

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D0570C00003

Identifier Type: -

Identifier Source: org_study_id

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