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

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)

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

Study Overview

• Status: Completed
• Conditions: Moderate to Severe COPD
• Intervention / Treatment: Drug: AZD1981; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 118
• Phase: Phase 2

Contacts and Locations

Study Locations

• Bulgaria
  • Pleven, Bulgaria
    • Research Site
  • Russe, Bulgaria
    • Research Site
  • Sofia, Bulgaria
    • Research Site
  • Varna, Bulgaria
    • Research Site
• Denmark
  • Arhus C, Denmark
    • Research Site
  • Hellerup, Denmark
    • Research Site
  • Hvidovre, Denmark
    • Research Site
  • Vaerlose, Denmark
    • Research Site
• Poland
  • Krakow, Poland
    • Research Site
  • Lublin, Poland
    • Research Site
  • Ostrow Wielkopolski, Poland
    • Research Site
  • Przemysl, Poland
    • Research Site
  • Rzeszow, Poland
    • Research Site
• Slovakia
  • Bojnice, Slovakia
    • Research Site
  • Liptovsky Hradok, Slovakia
    • Research Site
  • Poprad, Slovakia
    • Research Site
  • Spisska Nova Ves, Slovakia
    • Research Site
  • Zilina, Slovakia
    • Research Site
• Sweden
  • Lund, Sweden
    • Research Site
  • Stockholm, Sweden
    • Research Site
  • Uppsala, Sweden
    • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 36 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
FEV1	Mean change in FEV1 from baseline to Week 4 (last measurement post dose used, if data missing)	Baseline and Week 4
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).	Baseline and Week 4

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Forced Vital Capacity	Mean change in FVC from baseline to Week 4 (last measurement post dose used, if data missing)	Baseline and Week 4
Slow Vital Capacity	Mean change in SVC from baseline to Week 4 (last measurement post dose used, if data missing)	Baseline and Week 4
Inspiratory Capacity	Mean change in IC from baseline to Week 4 (last measurement post dose used, if data missing)	Baseline and Week 4
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)	Baseline and Week 4
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).	Baseline and 4-week treatment period average
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).	Baseline and 4-week treatment period average
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).	Baseline and 4-week treatment period average
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).	Baseline and 4-week treatment period average
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).	Baseline and 4-week treatment period average
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).	Baseline and 4-week treatment period average
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).	Baseline and 4-week treatment period average
Adverse Event	The number of participants that experienced at least one adverse event.	Up to 4 Weeks

Collaborators and Investigators

• Sponsor: AstraZeneca
• Investigators: Principal Investigator: Jörgen Vestbo, Professor in Respiratory Medicine, Hvidovre, Denmark

Publications and helpful links

General Publications

• 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.

Helpful Links

• Related Info
• CSR-D9831C00001.pdf

Study record dates

Study Major Dates

• Study Start: May 1, 2008
• Primary Completion (Actual): December 1, 2008
• Study Completion (Actual): December 1, 2008

Study Registration Dates

• First Submitted: May 30, 2008
• First Submitted That Met QC Criteria: June 2, 2008
• First Posted (Estimate): June 4, 2008

Study Record Updates

• Last Update Posted (Estimate): January 15, 2014
• Last Update Submitted That Met QC Criteria: December 13, 2013
• Last Verified: December 1, 2013

More Information

Terms related to this study

• Keywords: COPD
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: D9831C00001