Study to Assess the Efficacy and Safety of AZD1981 in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)

NCT ID: NCT00690482

Last Updated: 2014-01-15

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

118 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-05-31

Study Completion Date

2008-12-31

Brief Summary

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The purpose of this study is to study efficacy and safety of AZD1981 in patients with Chronic Obstructive Pulmonary Disease

Detailed Description

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Conditions

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Moderate to Severe 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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AZD1981

AZD1981 Oral tablet, twice daily

Group Type EXPERIMENTAL

AZD1981

Intervention Type DRUG

Oral tablet, twice daily

Placebo

Placebo Oral tablet, twice daily

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo Oral tablet, twice daily

Interventions

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AZD1981

Oral tablet, twice daily

Intervention Type DRUG

Placebo

Placebo Oral tablet, twice daily

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* FEV1 between 30 and 80% of predicted normal value post-bronchodilator (GOLD stages 2 and 3)
* Clinical diagnosis of COPD

Exclusion Criteria

* Other clinically relevant disease or disorders
* Exacerbation of COPD within 30 days
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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Jörgen Vestbo

Role: PRINCIPAL_INVESTIGATOR

Professor in Respiratory Medicine, Hvidovre, Denmark

Locations

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Research Site

Pleven, , Bulgaria

Site Status

Research Site

Rousse, , Bulgaria

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Sofia, , Bulgaria

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Varna, , Bulgaria

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Arhus C, , Denmark

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Hellerup, , Denmark

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Hvidovre, , Denmark

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Værløse, , Denmark

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Krakow, , Poland

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Lublin, , Poland

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Ostrów Wielkopolski, , Poland

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Przemyśl, , Poland

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Rzeszów, , Poland

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Bojnice, , Slovakia

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Liptovský Hrádok, , Slovakia

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Poprad, , Slovakia

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Spišská Nová Ves, , Slovakia

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Žilina, , Slovakia

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Lund, , Sweden

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Stockholm, , Sweden

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Uppsala, , Sweden

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Countries

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Bulgaria Denmark Poland Slovakia Sweden

References

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Snell N, Foster M, Vestbo J. Efficacy and safety of AZD1981, a CRTH2 receptor antagonist, in patients with moderate to severe COPD. Respir Med. 2013 Nov;107(11):1722-30. doi: 10.1016/j.rmed.2013.06.006. Epub 2013 Jul 1.

Reference Type DERIVED
PMID: 23827726 (View on PubMed)

Other Identifiers

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D9831C00001

Identifier Type: -

Identifier Source: org_study_id

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