Moderate to Severe COPDPhase 2ColumbusNCT00690482

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

A Phase 2 study testing AZD1981 in people with Moderate to Severe COPD, run by AstraZeneca at 21 sites in 5 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

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

Who is it for?: Ages 40 years and older
Conditions the study is for: Moderate to Severe COPD
What is being tested?: AZD1981
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 118 participants
Where: 21 sitesin 5 countries
Study dates: May 2008to Dec 2008
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 40 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

21 sites in 5 countries.

Country

City, postcode or hospital

21 sites in 5 countries

Poland5 sites

Research Site
Krakow
Research Site
Lublin
Research Site
Ostrów Wielkopolski
Research Site
Przemyśl
Research Site
Rzeszów

Other trials in Poland

Slovakia5 sites

Research Site
Bojnice
Research Site
Liptovský Hrádok
Research Site
Poprad
Research Site
Spišská Nová Ves
Research Site
Žilina

Other trials in Slovakia

Bulgaria4 sites

Research Site
Pleven
Research Site
Rousse
Research Site
Sofia
Research Site
Varna

Other trials in Bulgaria

Denmark4 sites

Research Site
Arhus C
Research Site
Hellerup
Research Site
Hvidovre
Research Site
Værløse

Other trials in Denmark

Sweden3 sites

Research Site
Lund
Research Site
Stockholm
Research Site
Uppsala

Other trials in Sweden

About this study

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)

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

Conditions: Moderate to Severe COPD
Being tested: AZD1981, Placebo
Keywords: COPD
Medical subject headings: Pulmonary Disease, Chronic Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AZD1981Drug
Oral tablet, twice daily
PlaceboDrug
Placebo Oral tablet, twice daily

Study groups in NCT00690482
Study group	Role	What they receive
AZD1981	Experimental	AZD1981 Oral tablet, twice daily Receives: Drug: AZD1981
Placebo	Placebo comparator	Placebo Oral tablet, twice daily Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

FEV1
Mean change in FEV1 from baseline to Week 4 (last measurement post dose used, if data missing)
Measured: 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).
Measured: Baseline and Week 4

Secondary outcomes (12)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2008Dec 2008

First posted4 Jun 2008 (estimated)
Study startMay 2008
Primary completionDec 2008
Study completionDec 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Moderate to Severe COPDStudies of the same condition, open and under way.
More trials run by AstraZenecaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 118 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00690482
Sponsor's protocol ID: D9831C00001
Acronym: Columbus
Status last verified: Dec 2013
First submitted: 30 May 2008
Last updated: 15 Jan 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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.
PubMed 23827726

Study at a glance

From the registry record, last updated by the sponsor on 15 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

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)
ClinicalTrials.gov ID: NCT00690482
Acronym / sponsor ID: Columbus / D9831C00001
Conditions: Moderate to Severe COPD
Keywords: COPD
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 118 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: May 2008
Primary completion: Dec 2008 (actual)
Study completion: Dec 2008 (actual)
First posted: 4 Jun 2008 (estimated)
Results: Posted 6 Dec 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
AZD1981	Experimental	Drug: AZD1981AZD1981 Oral tablet, twice daily
Placebo	Placebo comparator	Drug: PlaceboPlacebo Oral tablet, twice daily

Who may qualify

Ages: 40 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

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

Key exclusion criteria (2 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
AZD1981Oral tablet, twice daily	Drug	AZD1981
PlaceboPlacebo Oral tablet, twice daily	Drug	Placebo

Primary outcome

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

12 secondary outcomes

Forced Vital Capacity
Time frame: Baseline and Week 4
Slow Vital Capacity
Time frame: Baseline and Week 4
Inspiratory Capacity
Time frame: Baseline and Week 4
FEF25%-75%
Time frame: Baseline and Week 4
COPD Symptom Sleep Score
Time frame: Baseline and 4-week treatment period average
COPD Symptom Breathing Score
Time frame: Baseline and 4-week treatment period average
COPD Symptom Cough Score
Time frame: Baseline and 4-week treatment period average
COPD Symptom Sputum Score
Time frame: Baseline and 4-week treatment period average
PEF (Peak Expiratory Flow) Morning
Time frame: Baseline and 4-week treatment period average
PEF (Peak Expiratory Flow) Evening
Time frame: Baseline and 4-week treatment period average
Total Use of Reliever
Time frame: Baseline and 4-week treatment period average
Adverse Event
Time frame: Up to 4 Weeks

Results and safety

Results posted to the registry on 6 Dec 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
AZD1981	61	57
Placebo	57	54

Primary outcome: FEV1

Time frame: Baseline and Week 4. Mean (Full Range). Unit: L

Measure	AZD1981 n = 60	Placebo n = 55
Value	0.007 (-0.810)	0.011 (-0.550)

Population analysed: The efficacy analysis is based on 117 randomized patients, 61 on AZD1981 and 56 on placebo. However, not all patients will have valid, non-missing values for a given outcome measure.

Primary outcome: Clinical COPD Questionnaire

Time frame: Baseline and Week 4. Mean (Full Range). Unit: Scores on a scale

Measure	AZD1981 n = 59	Placebo n = 55
Value	-0.299 (-2.00)	-0.340 (-2.20)

12 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
AZD1981	0 of 61 (0%)	8 of 61 (13.1%)	Not reported
Placebo	1 of 56 (1.8%)	6 of 56 (10.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 23827726Snell 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.
Related InfoLink provided by the sponsor.
CSR-D9831C00001.pdfLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jörgen Vestbo principal investigator

Professor in Respiratory Medicine, Hvidovre, Denmark

21 sites in 5 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing AZD1981 in people with Moderate to Severe COPD, run by AstraZeneca at 21 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 21 sites in Poland, Slovakia, Bulgaria, Denmark, Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Dec 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

FEV1 (time frame: Baseline and Week 4). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00690482, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2014.