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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)

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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
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
The purpose of this study is to study efficacy and safety of AZD1981 in patients with Chronic Obstructive Pulmonary Disease

Condition or disease Intervention/treatment Phase
Moderate to Severe COPD Drug: AZD1981 Drug: Placebo Phase 2

Study Design
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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD Lung Diseases
U.S. FDA Resources

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. FEV1 [ Time Frame: Baseline and Week 4 ]
    Mean change in FEV1 from baseline to Week 4 (last measurement post dose used, if data missing)

  2. 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 :
  1. 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)

  2. 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)

  3. 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)

  4. 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)

  5. 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).

  6. 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).

  7. 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).

  8. 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).

  9. 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).

  10. 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).

  11. 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).

  12. Adverse Event [ Time Frame: Up to 4 Weeks ]
    The number of participants that experienced at least one adverse event.


Eligibility Criteria
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Information from the National Library of Medicine

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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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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


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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site
CSR-D9831C00001.pdf  This link exits the ClinicalTrials.gov site

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