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Completed

NCT Number: NCT00690482

Study to Assess the Efficacy and Safety of AZD1981 in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)

The purpose of this study is to study efficacy and safety of AZD1981 in patients with Chronic Obstructive Pulmonary Disease

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Key information

Conditions

Moderate to Severe COPD Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Research Site, Pleven, Bulgaria

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AZD1981

Drug

Oral tablet, twice daily

Placebo

Drug

Placebo Oral tablet, twice daily

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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)

Acronym: Columbus

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Jun 4, 2008
Registry last updated
Jan 15, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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