NCT00690482

Brief Summary

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

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
118

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started May 2008

Shorter than P25 for phase_2

Geographic Reach
5 countries

21 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2008

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

May 30, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 4, 2008

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
5 years until next milestone

Results Posted

Study results publicly available

December 6, 2013

Completed
Last Updated

January 15, 2014

Status Verified

December 1, 2013

Enrollment Period

7 months

First QC Date

May 30, 2008

Results QC Date

July 1, 2013

Last Update Submit

December 13, 2013

Conditions

Moderate to Severe COPD

Keywords

COPD

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (12)

  • Forced Vital Capacity

    Baseline and Week 4

  • Slow Vital Capacity

    Baseline and Week 4

  • Inspiratory Capacity

    Baseline and Week 4

  • FEF25%-75%

    Baseline and Week 4

  • COPD Symptom Sleep Score

    Baseline and 4-week treatment period average

  • +7 more secondary outcomes

Study Arms (2)

AZD1981

EXPERIMENTAL

AZD1981 Oral tablet, twice daily

Drug: AZD1981

Placebo

PLACEBO COMPARATOR

Placebo Oral tablet, twice daily

Drug: Placebo

Interventions

AZD1981DRUG

Oral tablet, twice daily

AZD1981
PlaceboDRUG

Placebo Oral tablet, twice daily

Placebo

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • FEV1 between 30 and 80% of predicted normal value post-bronchodilator (GOLD stages 2 and 3)
  • Clinical diagnosis of COPD

You may not qualify if:

  • Other clinically relevant disease or disorders
  • Exacerbation of COPD within 30 days

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (21)

Research Site

Pleven, Bulgaria

Location

Research Site

Rousse, Bulgaria

Location

Research Site

Sofia, Bulgaria

Location

Research Site

Varna, Bulgaria

Location

Research Site

Arhus C, Denmark

Location

Research Site

Hellerup, Denmark

Location

Research Site

Hvidovre, Denmark

Location

Research Site

Værløse, Denmark

Location

Research Site

Krakow, Poland

Location

Research Site

Lublin, Poland

Location

Research Site

Ostrów Wielkopolski, Poland

Location

Research Site

Przemyśl, Poland

Location

Research Site

Rzeszów, Poland

Location

Research Site

Bojnice, Slovakia

Location

Research Site

Liptovský Hrádok, Slovakia

Location

Research Site

Poprad, Slovakia

Location

Research Site

Spišská Nová Ves, Slovakia

Location

Research Site

Žilina, Slovakia

Location

Research Site

Lund, Sweden

Location

Research Site

Stockholm, Sweden

Location

Research Site

Uppsala, Sweden

Location

Related Publications (1)

  • 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: 23827726DERIVED

Related Links

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

AZD1981

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Alison Holt
Organization
AstraZeneca
ClinicalTrialTransparency@astrazeneca.com

Study Officials

  • Jörgen Vestbo

    Professor in Respiratory Medicine, Hvidovre, Denmark

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 30, 2008

First Posted

June 4, 2008

Study Start

May 1, 2008

Primary Completion

December 1, 2008

Study Completion

December 1, 2008

Last Updated

January 15, 2014

Results First Posted

December 6, 2013

Record last verified: 2013-12

Locations

DK(4)PL(5)SL(5)SE(3)BU(4)