Back to resultsStudy to Assess the Efficacy and Safety of AZD1981 in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) (Columbus)
Primary Purpose
Moderate to Severe COPD
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
AZD1981
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Moderate to Severe COPD focused on measuring COPD
Eligibility 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
Sites / Locations
- Research Site
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Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
AZD1981
Placebo
Arm Description
AZD1981 Oral tablet, twice daily
Placebo Oral tablet, twice daily
Outcomes
Primary Outcome Measures
FEV1
Mean change in FEV1 from baseline to Week 4 (last measurement post dose used, if data missing)
Clinical COPD Questionnaire
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
Mean change in FVC from baseline to Week 4 (last measurement post dose used, if data missing)
Slow Vital Capacity
Mean change in SVC from baseline to Week 4 (last measurement post dose used, if data missing)
Inspiratory Capacity
Mean change in IC from baseline to Week 4 (last measurement post dose used, if data missing)
FEF25%-75%
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
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
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
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
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
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
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
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
The number of participants that experienced at least one adverse event.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00690482
Brief Title
Study to Assess the Efficacy and Safety of AZD1981 in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
Acronym
Columbus
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)
Study Type
Interventional
2. Study Status
Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
May 2008 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
December 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to study efficacy and safety of AZD1981 in patients with Chronic Obstructive Pulmonary Disease
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Moderate to Severe COPD
Keywords
COPD
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
118 (Actual)
8. Arms, Groups, and Interventions
Arm Title
AZD1981
Arm Type
Experimental
Arm Description
AZD1981 Oral tablet, twice daily
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo Oral tablet, twice daily
Intervention Type
Drug
Intervention Name(s)
AZD1981
Intervention Description
Oral tablet, twice daily
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo Oral tablet, twice daily
Primary Outcome Measure Information:
Title
FEV1
Description
Mean change in FEV1 from baseline to Week 4 (last measurement post dose used, if data missing)
Time Frame
Baseline and Week 4
Title
Clinical COPD Questionnaire
Description
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).
Time Frame
Baseline and Week 4
Secondary Outcome Measure Information:
Title
Forced Vital Capacity
Description
Mean change in FVC from baseline to Week 4 (last measurement post dose used, if data missing)
Time Frame
Baseline and Week 4
Title
Slow Vital Capacity
Description
Mean change in SVC from baseline to Week 4 (last measurement post dose used, if data missing)
Time Frame
Baseline and Week 4
Title
Inspiratory Capacity
Description
Mean change in IC from baseline to Week 4 (last measurement post dose used, if data missing)
Time Frame
Baseline and Week 4
Title
FEF25%-75%
Description
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)
Time Frame
Baseline and Week 4
Title
COPD Symptom Sleep Score
Description
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).
Time Frame
Baseline and 4-week treatment period average
Title
COPD Symptom Breathing Score
Description
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).
Time Frame
Baseline and 4-week treatment period average
Title
COPD Symptom Cough Score
Description
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).
Time Frame
Baseline and 4-week treatment period average
Title
COPD Symptom Sputum Score
Description
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).
Time Frame
Baseline and 4-week treatment period average
Title
PEF (Peak Expiratory Flow) Morning
Description
Mean change in PEF morning from baseline to treatment period average (calculated using all available data after randomisation for each patient).
Time Frame
Baseline and 4-week treatment period average
Title
PEF (Peak Expiratory Flow) Evening
Description
Mean change in PEF evening from baseline to treatment period average (calculated using all available data after randomisation for each patient).
Time Frame
Baseline and 4-week treatment period average
Title
Total Use of Reliever
Description
Mean change in Total use of reliever from baseline to treatment period average (calculated using all available data after randomisation for each patient).
Time Frame
Baseline and 4-week treatment period average
Title
Adverse Event
Description
The number of participants that experienced at least one adverse event.
Time Frame
Up to 4 Weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jörgen Vestbo
Organizational Affiliation
Professor in Respiratory Medicine, Hvidovre, Denmark
Official's Role
Principal Investigator
Facility Information:
Facility Name
Research Site
City
Pleven
Country
Bulgaria
Facility Name
Research Site
City
Russe
Country
Bulgaria
Facility Name
Research Site
City
Sofia
Country
Bulgaria
Facility Name
Research Site
City
Varna
Country
Bulgaria
Facility Name
Research Site
City
Arhus C
Country
Denmark
Facility Name
Research Site
City
Hellerup
Country
Denmark
Facility Name
Research Site
City
Hvidovre
Country
Denmark
Facility Name
Research Site
City
Vaerlose
Country
Denmark
Facility Name
Research Site
City
Krakow
Country
Poland
Facility Name
Research Site
City
Lublin
Country
Poland
Facility Name
Research Site
City
Ostrow Wielkopolski
Country
Poland
Facility Name
Research Site
City
Przemysl
Country
Poland
Facility Name
Research Site
City
Rzeszow
Country
Poland
Facility Name
Research Site
City
Bojnice
Country
Slovakia
Facility Name
Research Site
City
Liptovsky Hradok
Country
Slovakia
Facility Name
Research Site
City
Poprad
Country
Slovakia
Facility Name
Research Site
City
Spisska Nova Ves
Country
Slovakia
Facility Name
Research Site
City
Zilina
Country
Slovakia
Facility Name
Research Site
City
Lund
Country
Sweden
Facility Name
Research Site
City
Stockholm
Country
Sweden
Facility Name
Research Site
City
Uppsala
Country
Sweden
12. IPD Sharing Statement
Citations:
PubMed Identifier
23827726
Citation
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.
Results Reference
derived
Links:
URL
http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=215&filename=CSR-D9831C00001.pdf
Description
Related Info
URL
http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=215&filename=CSR-D9831C00001.pdf
Description
CSR-D9831C00001.pdf
Learn more about this trial
Study to Assess the Efficacy and Safety of AZD1981 in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
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