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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00690482
First received: May 30, 2008
Last updated: January 12, 2009
Last verified: January 2009
History of Changes
  Purpose

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


Condition Intervention Phase
Moderate to Severe COPD
 Drug: AZD1981
Drug: Placebo
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A 4 Week Double-Blind, Placebo-Controlled, Randomized, Parallel Group Phase IIa Study to Assess the Efficacy and Safety of AZD1981 in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • FEV1 [ Time Frame: At each clinic visit except follow-up ] [ Designated as safety issue: No ]
  • Clinical COPD Questionnaire [ Time Frame: At each clinic visit except follow-up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Other lung function measurements [ Time Frame: At each clinic visit except follow-up ] [ Designated as safety issue: No ]
  • Adverse events [ Time Frame: At each clinic visit ] [ Designated as safety issue: Yes ]
  • Diary card variables (symptoms, PEF) [ Time Frame: Daily diary ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 100
Study Start Date: May 2008
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: AZD1981
Oral tablet, twice daily, 4 weeks treatment
Placebo Comparator: 2 Drug: Placebo

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00690482

Locations
Bulgaria
Research Site
Pleven, Bulgaria
Research Site
Russe, Bulgaria
Research Site
Sofia, Bulgaria
Research Site
Varna, Bulgaria
Denmark
Research Site
Arhus C, Denmark
Research Site
Hellerup, Denmark
Research Site
Hvidovre, Denmark
Research Site
Vaerlose, Denmark
Poland
Research Site
Krakow, Poland
Research Site
Lublin, Poland
Research Site
Ostrow Wielkopolski, Poland
Research Site
Przemysl, Poland
Research Site
Rzeszow, Poland
Slovakia
Research Site
Bojnice, Slovakia
Research Site
Liptovsky Hradok, Slovakia
Research Site
Poprad, Slovakia
Research Site
Spisska Nova Ves, Slovakia
Research Site
Zilina, Slovakia
Sweden
Research Site
Lund, Sweden
Research Site
Stockholm, Sweden
Research Site
Uppsala, Sweden
Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: Jörgen Vestbo Professor in Respiratory Medicine, Hvidovre, Denmark
  More Information

No publications provided

Responsible Party: Christer Hultquist, MD, Medical Science Director, R&D, AstraZeneca Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00690482     History of Changes
Other Study ID Numbers: D9831C00001
Study First Received: May 30, 2008
Last Updated: January 12, 2009
Health Authority: Bulgaria: Bulgarian Drug Agency
Denmark: Danish Medicines Agency
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Slovakia: State Institute for Drug Control
Sweden: Medical Products Agency

Keywords provided by AstraZeneca:
COPD

Additional relevant MeSH terms:
Lung Diseases
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 16, 2013