IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. 
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:
AstraZeneca
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00690482
First received: May 30, 2008
Last updated: December 13, 2013
Last verified: December 2013
- Full Text View
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
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 Intervention Model: Parallel Assignment Masking: Double Blind (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) |
Resource links provided by NLM:
Further study details as provided by AstraZeneca:
Primary Outcome Measures:
- 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).
Secondary Outcome Measures:
- 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.
| 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 (Adult, Senior) |
| Sexes Eligible for Study: | All |
| 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
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:
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 |
| Study First Received: | May 30, 2008 |
| Results First Received: | July 1, 2013 |
| Last Updated: | December 13, 2013 |
Keywords provided by AstraZeneca:
|
COPD |
Additional relevant MeSH terms:
|
Lung Diseases Lung Diseases, Obstructive Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on June 23, 2017