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

• AZD1981 (Drug): Oral tablet, twice daily
• Placebo (Drug): Placebo Oral tablet, twice daily

Primary outcomes

• FEV1 [Baseline and Week 4]: Mean change in FEV1 from baseline to Week 4 (last measurement post dose used, if data missing)
• Clinical COPD Questionnaire [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

• Forced Vital Capacity [Baseline and Week 4]: Mean change in FVC from baseline to Week 4 (last measurement post dose used, if data missing)
• Slow Vital Capacity [Baseline and Week 4]: Mean change in SVC from baseline to Week 4 (last measurement post dose used, if data missing)
• Inspiratory Capacity [Baseline and Week 4]: Mean change in IC from baseline to Week 4 (last measurement post dose used, if data missing)
• FEF25%-75% [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 [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 [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 [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 [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 [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 [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 [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 [Up to 4 Weeks]: The number of participants that experienced at least one adverse event.

Sex: All, ages: 40 Years to any

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

Participant flow

Outcome results

• FEV1 (Primary), Mean, L: AZD1981 0.007 (-0.810 to 0.740); Placebo 0.011 (-0.550 to 0.550)
• Clinical COPD Questionnaire (Primary), Mean, Scores on a scale: AZD1981 -0.299 (-2.00 to 1.30); Placebo -0.340 (-2.20 to 1.30)
• Forced Vital Capacity (Secondary), Mean, L: AZD1981 -0.047 (-1.74 to 0.840); Placebo -0.102 (-1.09 to 0.870)
• Slow Vital Capacity (Secondary), Mean, L: AZD1981 -0.001 (-1.03 to 2.30); Placebo -0.009 (-1.60 to 0.910)
• Inspiratory Capacity (Secondary), Mean, L: AZD1981 -0.007 (-0.960 to 1.08); Placebo -0.110 (-1.39 to 1.59)
• FEF25%-75% (Secondary), Mean, L/s: AZD1981 -0.042 (-0.900 to 0.440); Placebo 0.060 (-0.640 to 2.48)
• COPD Symptom Sleep Score (Secondary), Mean, Scores on a scale: AZD1981 -0.147 (-1.55 to 1.00); Placebo -0.047 (-1.75 to 1.80)
• COPD Symptom Breathing Score (Secondary), Mean, Scores on a scale: AZD1981 -0.280 (-2.07 to 0.486); Placebo -0.137 (-1.41 to 1.52)
• COPD Symptom Cough Score (Secondary), Mean, Scores on a scale: AZD1981 -0.202 (-2.09 to 1.22); Placebo -0.124 (-1.79 to 1.01)
• COPD Symptom Sputum Score (Secondary), Mean, Scores on a scale: AZD1981 -0.300 (-1.50 to 0.844); Placebo -0.290 (-1.58 to 0.796)
• PEF (Peak Expiratory Flow) Morning (Secondary), Mean, L/min: AZD1981 2.86 (-45.0 to 113); Placebo 4.54 (-37.2 to 77.9)
• PEF (Peak Expiratory Flow) Evening (Secondary), Mean, L/min: AZD1981 -1.61 (-66.5 to 115); Placebo 5.73 (-35.1 to 61.8)
• Total Use of Reliever (Secondary), Mean, Number of inhalations per day: AZD1981 -0.330 (-7.64 to 3.81); Placebo -0.139 (-3.69 to 9.90)
• Adverse Event (Secondary), Number, Participants: AZD1981 20; Placebo 18

Adverse events

Serious adverse events by term

Other adverse events by term

• Results publication: 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. PMID 23827726

• Jörgen Vestbo, Principal investigator, Professor in Respiratory Medicine, Hvidovre, Denmark