Clinical trial NCT00690482: Study to Assess the Efficacy and Safety of AZD1981 in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Moderate to Severe COPD
Keywords: COPD
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-06-04
Enrollment: 118
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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

Primary outcomes:
measure: FEV1
timeFrame: Baseline and Week 4
measure: Clinical COPD Questionnaire
timeFrame: Baseline and Week 4
Secondary outcomes:
measure: Forced Vital Capacity
timeFrame: Baseline and Week 4
measure: Slow Vital Capacity
timeFrame: Baseline and Week 4
measure: Inspiratory Capacity
timeFrame: Baseline and Week 4
measure: FEF25%-75%
timeFrame: Baseline and Week 4
measure: COPD Symptom Sleep Score
timeFrame: Baseline and 4-week treatment period average
measure: COPD Symptom Breathing Score
timeFrame: Baseline and 4-week treatment period average
measure: COPD Symptom Cough Score
timeFrame: Baseline and 4-week treatment period average
measure: COPD Symptom Sputum Score
timeFrame: Baseline and 4-week treatment period average
measure: PEF (Peak Expiratory Flow) Morning
timeFrame: Baseline and 4-week treatment period average
measure: PEF (Peak Expiratory Flow) Evening
timeFrame: Baseline and 4-week treatment period average
measure: Total Use of Reliever
timeFrame: Baseline and 4-week treatment period average
measure: Adverse Event
timeFrame: Up to 4 Weeks
Other outcomes:
Locations:
city: Pleven
country: Bulgaria
facility: Research Site
city: Russe
country: Bulgaria
facility: Research Site
city: Sofia
country: Bulgaria
facility: Research Site
city: Varna
country: Bulgaria
facility: Research Site
city: Arhus C
country: Denmark
facility: Research Site
city: Hellerup
country: Denmark
facility: Research Site
city: Hvidovre
country: Denmark
facility: Research Site
city: Vaerlose
country: Denmark
facility: Research Site
city: Krakow
country: Poland
facility: Research Site
city: Lublin
country: Poland
facility: Research Site
city: Ostrow Wielkopolski
country: Poland
facility: Research Site
city: Przemysl
country: Poland
facility: Research Site
city: Rzeszow
country: Poland
facility: Research Site
city: Bojnice
country: Slovakia
facility: Research Site
city: Liptovsky Hradok
country: Slovakia
facility: Research Site
city: Poprad
country: Slovakia
facility: Research Site
city: Spisska Nova Ves
country: Slovakia
facility: Research Site
city: Zilina
country: Slovakia
facility: Research Site
city: Lund
country: Sweden
facility: Research Site
city: Stockholm
country: Sweden
facility: Research Site
city: Uppsala
country: Sweden
facility: Research Site
Study officials:
affiliation: Professor in Respiratory Medicine, Hvidovre, Denmark
name: Jörgen Vestbo
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.