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 (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00690482
First received: May 30, 2008
Last updated: December 13, 2013
Last verified: December 2013
  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:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • FEV1 [ Time Frame: Baseline and Week 4 ] [ Designated as safety issue: No ]
    Mean change in FEV1 from baseline to Week 4 (last measurement post dose used, if data missing)

  • Clinical COPD Questionnaire [ Time Frame: Baseline and Week 4 ] [ Designated as safety issue: No ]
    Mean change in Total CCQ from baseline to Week 4 (last measurement post dose used, if data missing). Scores for total CCQ range from 0 (low symptoms) to 6 (high symptoms).


Secondary Outcome Measures:
  • Forced Vital Capacity [ Time Frame: Baseline and Week 4 ] [ Designated as safety issue: No ]
    Mean change in FVC from baseline to Week 4 (last measurement post dose used, if data missing)

  • Slow Vital Capacity [ Time Frame: Baseline and Week 4 ] [ Designated as safety issue: No ]
    Mean change in SVC from baseline to Week 4 (last measurement post dose used, if data missing)

  • Inspiratory Capacity [ Time Frame: Baseline and Week 4 ] [ Designated as safety issue: No ]
    Mean change in IC from baseline to Week 4 (last measurement post dose used, if data missing)

  • FEF25%-75% [ Time Frame: Baseline and Week 4 ] [ Designated as safety issue: No ]
    Mean change in FEF25%-75% (forced expiratory flow between 25% and 75% of the FVC) from baseline to Week 4 (last measurement post dose used, if data missing)

  • COPD Symptom Sleep Score [ Time Frame: Baseline and 4-week treatment period average ] [ Designated as safety issue: No ]
    Mean change in COPD symptom sleep score from baseline to treatment period average (calculated using all available data after randomisation for each patient). Scores for COPD symptom sleep score range from 0 (no symptoms) to 4 (no sleep).

  • COPD Symptom Breathing Score [ Time Frame: Baseline and 4-week treatment period average ] [ Designated as safety issue: No ]
    Mean change in COPD symptom breathing score from baseline to treatment period average (calculated using all available data after randomisation for each patient). Scores for COPD symptom breathing score range from 0 (none) to 4 (severe).

  • COPD Symptom Cough Score [ Time Frame: Baseline and 4-week treatment period average ] [ Designated as safety issue: No ]
    Mean change in COPD symptom cough score from baseline to treatment period average (calculated using all available data after randomisation for each patient). Scores for COPD symptom cough score range from 0 (none) to 4 (almost constant).

  • COPD Symptom Sputum Score [ Time Frame: Baseline and 4-week treatment period average ] [ Designated as safety issue: No ]
    Mean change in COPD symptom sputum score from baseline to treatment period average (calculated using all available data after randomisation for each patient). Scores for COPD symptom sputum score range from 0 (none) to 4 (severe).

  • PEF (Peak Expiratory Flow) Morning [ Time Frame: Baseline and 4-week treatment period average ] [ Designated as safety issue: No ]
    Mean change in PEF morning from baseline to treatment period average (calculated using all available data after randomisation for each patient).

  • PEF (Peak Expiratory Flow) Evening [ Time Frame: Baseline and 4-week treatment period average ] [ Designated as safety issue: No ]
    Mean change in PEF evening from baseline to treatment period average (calculated using all available data after randomisation for each patient).

  • Total Use of Reliever [ Time Frame: Baseline and 4-week treatment period average ] [ Designated as safety issue: No ]
    Mean change in Total use of reliever from baseline to treatment period average (calculated using all available data after randomisation for each patient).

  • Adverse Event [ Time Frame: Up to 4 Weeks ] [ Designated as safety issue: No ]
    The number of participants that experienced at least one adverse event.


Enrollment: 118
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: AZD1981
AZD1981 Oral tablet, twice daily
Drug: AZD1981
Oral tablet, twice daily
Placebo Comparator: Placebo
Placebo Oral tablet, twice daily
Drug: Placebo
Placebo Oral tablet, twice daily

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Additional Information:
No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00690482     History of Changes
Other Study ID Numbers: D9831C00001
Study First Received: May 30, 2008
Results First Received: July 1, 2013
Last Updated: December 13, 2013
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 July 22, 2014