Study to Assess the Efficacy and Safety of AZD1981 in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) (Columbus)
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ClinicalTrials.gov Identifier: NCT00690482 |
Recruitment Status
:
Completed
First Posted
: June 4, 2008
Results First Posted
: December 6, 2013
Last Update Posted
: January 15, 2014
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Moderate to Severe COPD | Drug: AZD1981 Drug: Placebo | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 118 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, 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) |
Study Start Date : | May 2008 |
Actual Primary Completion Date : | December 2008 |
Actual Study Completion Date : | December 2008 |
Arm | Intervention/treatment |
---|---|
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
|
- FEV1 [ Time Frame: Baseline and Week 4 ]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 ]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).
- Forced Vital Capacity [ Time Frame: Baseline and Week 4 ]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 ]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 ]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 ]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 ]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 ]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 ]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 ]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 ]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 ]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 ]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 ]The number of participants that experienced at least one adverse event.

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Ages Eligible for Study: | 40 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00690482
Bulgaria | |
Research Site | |
Pleven, Bulgaria | |
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Russe, Bulgaria | |
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Sofia, Bulgaria | |
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Varna, Bulgaria | |
Denmark | |
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Arhus C, Denmark | |
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Hellerup, Denmark | |
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Hvidovre, Denmark | |
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Vaerlose, Denmark | |
Poland | |
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Krakow, Poland | |
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Lublin, Poland | |
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Ostrow Wielkopolski, Poland | |
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Przemysl, Poland | |
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Rzeszow, Poland | |
Slovakia | |
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Bojnice, Slovakia | |
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Liptovsky Hradok, Slovakia | |
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Poprad, Slovakia | |
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Spisska Nova Ves, Slovakia | |
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Zilina, Slovakia | |
Sweden | |
Research Site | |
Lund, Sweden | |
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Stockholm, Sweden | |
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Uppsala, Sweden |
Principal Investigator: | Jörgen Vestbo | Professor in Respiratory Medicine, Hvidovre, Denmark |
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | AstraZeneca |
ClinicalTrials.gov Identifier: | NCT00690482 History of Changes |
Other Study ID Numbers: |
D9831C00001 |
First Posted: | June 4, 2008 Key Record Dates |
Results First Posted: | December 6, 2013 |
Last Update Posted: | January 15, 2014 |
Last Verified: | December 2013 |
Keywords provided by AstraZeneca:
COPD |
Additional relevant MeSH terms:
Lung Diseases Lung Diseases, Obstructive Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases |