Chronic Obstructive Pulmonary DiseasePhase 2BiopsyNCT00766415

14729-D9831C00002- 1 Month Biopsy Study

A Phase 2 study testing AZD1981 in people with Chronic Obstructive Pulmonary Disease, run by AstraZeneca at 8 sites in 3 countries.

Completed

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

Official record

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Trial summary

The purpose of this study is to study histological changes, cellularity, clinical 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: Chronic Obstructive Pulmonary Disease
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: 52 participants
Where: 8 sitesin 3 countries
Study dates: Nov 2008to Jun 2009
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

Men or women 40 years or above
FEV1 between 40 and 80% of predicted normal value post-bronchodilator
Clinical diagnosis of COPD

Who cannot join

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

Trial locations and contacts

8 sites in 3 countries.

Country

City, postcode or hospital

8 sites in 3 countries

United Kingdom4 sites

Research Site
Leicester
Research Site
London
Research Site
Manchester
Research Site
Newcastle upon Tyne

Other trials in United Kingdom

Germany3 sites

Research Site
Frieburg
Research Site
Großhansdorf
Research Site
Hanover

Other trials in Germany

Netherlands1 site

Research Site
Amsterdam

Other trials in Netherlands

About this study

Official title: A Double-blind, Placebo-controlled, Randomised, Parallel Group Phase IIa Study to Evaluate the Histological Changes, Cellularity, Clinical Efficacy and Safety of AZD1981 in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)

The purpose of this study is to study histological changes, cellularity, clinical efficacy and safety of AZD1981 in patients with Chronic Obstructive Pulmonary Disease

Conditions: Chronic Obstructive Pulmonary Disease
Being tested: AZD1981, Placebo
Keywords: COPD, Moderate to severe 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, 4 weeks treatment
PlaceboDrug
Placebo

Study groups in NCT00766415
Study group	Role	What they receive
AZD1981	Experimental	Not described Receives: Drug: AZD1981
Placebo	Placebo comparator	Not described Receives: Drug: Placebo

What is being measured

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

Aggregated Pathology Score
Composite endpoint subscores: histological grade, immunohistochemistry grade, leucocyte counts. Each subscore measured on scale 1 (normal) to 5 (worst outcome). Composite score summed across the subscores, ranging from 3 (normal) to 15 (worst outcome). Change from baseline.
Measured: Before and after 1 month treatment
Bronchoalveolar Lavage (BAL): Eosinophil Count (%)
Change in Bronchoalveolar Lavage (BAL): Eosinophil count (% of total) from baseline
Measured: Before and after 1 month treatment
Bronchoalveolar Lavage (BAL): Neutrophil Count (%)
Change in Bronchoalveolar Lavage (BAL): Neutrophil count (% of total) from baseline
Measured: Before and after 1 month treatment
Bronchoalveolar Lavage (BAL): Macrophages Count (%)
Change in Bronchoalveolar Lavage (BAL): Macrophages count (% of total) from baseline
Measured: Before and after 1 month treatment
Bronchoalveolar Lavage (BAL): Lymphocytes Count (%)
Change in Bronchoalveolar Lavage (BAL): Lymphocytes count (% of total) from baseline
Measured: Before and after 1 month treatment
Bronchoalveolar Lavage (BAL): Epithelial Cells Count (%)
Change in Bronchoalveolar Lavage (BAL): Epithelial cells count (% of total) from baseline
Measured: Before and after 1 month treatment
Bronchoalveolar Lavage (BAL): Total Cells Count
Change in Bronchoalveolar Lavage (BAL): Total cells count from baseline
Measured: Before and after 1 month treatment
Induced Sputum: Eosinophil Count (%)
Change in Induced sputum Eosinophil count (% of total) from baseline
Measured: Before and after 3 week treatment
Induced Sputum: Neutrophils Count (%)
Change in Induced sputum Neutrophils count (% of total) from baseline
Measured: Before and after 3 week treatment
Induced Sputum: Macrophages Count (%)
Change in Induced sputum Macrophages count (% of total) from baseline
Measured: Before and after 3 week treatment
Induced Sputum: Lymphocytes Count (%)
Change in Induced sputum Lymphocytes count (% of total) from baseline
Measured: Before and after 3 week treatment
Induced Sputum: Epithelial Cells Count (%)
Change in Induced sputum Epithelial cells count (% of total) from baseline
Measured: Before and after 3 week treatment
Induced Sputum: Total Cells Count
Change in Induced sputum Total cells count from baseline
Measured: Before and after 3 week treatment

Secondary outcomes (9)

Forced Expiratory Volume in 1 Second (FEV1)
Change in Forced Expiratory Volume in 1 second (FEV1) from baseline to end of treatment
Measured: Before and after 1 month treatment
Clinical Chronic Obstructive Pulmonary Disease (COPD) The Clinical COPD Questionnaire (CCQ)
Change in total CCQ score from baseline to last measurement on treatment. scored on a scale of 0 - 6. 0 =(low symptoms)-6 =(high symptoms)
Measured: Before and after 1 month treatment
Peak Expiratory Flow (PEF) Morning
Mean change in Peak Expiratory Flow (PEF) morning from baseline to the average of the treatment period
Measured: Before and after 1 month treatment
Peak Expiratory Flow (PEF) Evening
Mean change in Peak Expiratory Flow (PEF) evening from baseline to the average of the treatment period
Measured: Before and after 1 month treatment
Chronic Obstructive Pulmonary Disease (COPD) Symptom Night-time Awakenings Score
Mean change in COPD symptom night-time awakening score from baseline to the average of the treatment period. 0=(no symptom)-4=(no sleep)
Measured: Before and after 1 month treatment
Chronic Obstructive Pulmonary Disease (COPD) Symptom Breathing Score
Mean change in COPD symptom breathing score from baseline to the average of the treatment period. 0= (none) - 4 =(severe).
Measured: Before and after 1 month treatment
Chronic Obstructive Pulmonary Disease (COPD) Symptom Cough Score
Mean change in COPD symptom cough score from baseline to the average of the treatment period. 0= (none) - 4= (almost constant)
Measured: Before and after 1 month treatment
Chronic Obstructive Pulmonary Disease (COPD) Symptom Sputum Score
Mean change in COPD symptom sputum score from baseline to the average of the treatment period. 0= (none) - 4= (severe).
Measured: Before and after 1 month treatment
Adverse Event (AE)
Number of participants with an Adverse Event
Measured: 1 month

Timeline

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

Nov 2008Jun 2009

First posted6 Oct 2008 (estimated)
Study startNov 2008
Study completionJun 2009

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.
Other trials for Chronic Obstructive Pulmonary DiseaseStudies 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: 52 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00766415
Sponsor's protocol ID: D9831C00002
Acronym: Biopsy
Status last verified: Jan 2014
First submitted: 3 Oct 2008
Last updated: 28 Feb 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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RecruitingPhase 2
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All Chronic Obstructive Pulmonary Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Double-blind, Placebo-controlled, Randomised, Parallel Group Phase IIa Study to Evaluate the Histological Changes, Cellularity, Clinical Efficacy and Safety of AZD1981 in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
ClinicalTrials.gov ID: NCT00766415
Acronym / sponsor ID: Biopsy / D9831C00002
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: COPD, Moderate to severe COPD
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 52 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: Nov 2008
Study completion: Jun 2009 (actual)
First posted: 6 Oct 2008 (estimated)
Results: Posted 28 Feb 2014

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 histological changes, cellularity, clinical 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: AZD1981
Placebo	Placebo comparator	Drug: Placebo

Who may qualify

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

Key inclusion criteria (3 listed)

Men or women 40 years or above
FEV1 between 40 and 80% of predicted normal value post-bronchodilator
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, 4 weeks treatment	Drug	AZD1981
PlaceboPlacebo	Drug	Placebo

Primary outcome

Aggregated Pathology Score
Time frame: Before and after 1 month treatment
Composite endpoint subscores: histological grade, immunohistochemistry grade, leucocyte counts. Each subscore measured on scale 1 (normal) to 5 (worst outcome). Composite score summed across the subscores, ranging from 3 (normal) to 15 (worst outcome). Change from baseline.
Bronchoalveolar Lavage (BAL): Eosinophil Count (%)
Time frame: Before and after 1 month treatment
Change in Bronchoalveolar Lavage (BAL): Eosinophil count (% of total) from baseline
Bronchoalveolar Lavage (BAL): Neutrophil Count (%)
Time frame: Before and after 1 month treatment
Change in Bronchoalveolar Lavage (BAL): Neutrophil count (% of total) from baseline
Bronchoalveolar Lavage (BAL): Macrophages Count (%)
Time frame: Before and after 1 month treatment
Change in Bronchoalveolar Lavage (BAL): Macrophages count (% of total) from baseline
Bronchoalveolar Lavage (BAL): Lymphocytes Count (%)
Time frame: Before and after 1 month treatment
Change in Bronchoalveolar Lavage (BAL): Lymphocytes count (% of total) from baseline
Bronchoalveolar Lavage (BAL): Epithelial Cells Count (%)
Time frame: Before and after 1 month treatment
Change in Bronchoalveolar Lavage (BAL): Epithelial cells count (% of total) from baseline
Bronchoalveolar Lavage (BAL): Total Cells Count
Time frame: Before and after 1 month treatment
Change in Bronchoalveolar Lavage (BAL): Total cells count from baseline
Induced Sputum: Eosinophil Count (%)
Time frame: Before and after 3 week treatment
Change in Induced sputum Eosinophil count (% of total) from baseline
Induced Sputum: Neutrophils Count (%)
Time frame: Before and after 3 week treatment
Change in Induced sputum Neutrophils count (% of total) from baseline
Induced Sputum: Macrophages Count (%)
Time frame: Before and after 3 week treatment
Change in Induced sputum Macrophages count (% of total) from baseline
Induced Sputum: Lymphocytes Count (%)
Time frame: Before and after 3 week treatment
Change in Induced sputum Lymphocytes count (% of total) from baseline
Induced Sputum: Epithelial Cells Count (%)
Time frame: Before and after 3 week treatment
Change in Induced sputum Epithelial cells count (% of total) from baseline
Induced Sputum: Total Cells Count
Time frame: Before and after 3 week treatment
Change in Induced sputum Total cells count from baseline

9 secondary outcomes

Forced Expiratory Volume in 1 Second (FEV1)
Time frame: Before and after 1 month treatment
Clinical Chronic Obstructive Pulmonary Disease (COPD) The Clinical COPD Questionnaire (CCQ)
Time frame: Before and after 1 month treatment
Peak Expiratory Flow (PEF) Morning
Time frame: Before and after 1 month treatment
Peak Expiratory Flow (PEF) Evening
Time frame: Before and after 1 month treatment
Chronic Obstructive Pulmonary Disease (COPD) Symptom Night-time Awakenings Score
Time frame: Before and after 1 month treatment
Chronic Obstructive Pulmonary Disease (COPD) Symptom Breathing Score
Time frame: Before and after 1 month treatment
Chronic Obstructive Pulmonary Disease (COPD) Symptom Cough Score
Time frame: Before and after 1 month treatment
Chronic Obstructive Pulmonary Disease (COPD) Symptom Sputum Score
Time frame: Before and after 1 month treatment
Adverse Event (AE)
Time frame: 1 month

Results and safety

Results posted to the registry on 28 Feb 2014, 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	25	25
Placebo	27	26

Primary outcome: Aggregated Pathology Score

Time frame: Before and after 1 month treatment. Mean (95% Confidence Interval). Unit: Score on a scale

Measure	AZD1981 n = 24	Placebo n = 26
Value	7.88 (7.43)	8.15 (7.68)

Population analysed: Efficacy analyses were performed on the full-analysis set, comprised of 51 patients: 25 in the AZD1981 group and 26 in the placebo group. However, not all patients will have valid, non-missing values for a given outcome measure.

Primary outcome: Bronchoalveolar Lavage (BAL): Eosinophil Count (%)

Time frame: Before and after 1 month treatment. Mean (95% Confidence Interval). Unit: percentage

Measure	AZD1981 n = 21	Placebo n = 22
Value	-1.58 (-2.22)	-1.45 (-2.13)

Primary outcome: Bronchoalveolar Lavage (BAL): Neutrophil Count (%)

Time frame: Before and after 1 month treatment. Mean (95% Confidence Interval). Unit: percentage

Measure	AZD1981 n = 21	Placebo n = 22
Value	-2.24 (-12.94)	-5.67 (-16.75)

Primary outcome: Bronchoalveolar Lavage (BAL): Macrophages Count (%)

Time frame: Before and after 1 month treatment. Mean (95% Confidence Interval). Unit: percentage

Measure	AZD1981 n = 21	Placebo n = 22
Value	9.84 (-1.51)	10.68 (-1.24)

9 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	1 of 25 (4%)	5 of 25 (20%)	Not reported
Placebo	0 of 26 (0%)	7 of 26 (26.9%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related InfoLink provided by the sponsor.
CSR-D9831C00002.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.

Norbert Krug principal investigator

Fraunhofer Institute

8 sites in 3 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 Chronic Obstructive Pulmonary Disease, run by AstraZeneca at 8 sites in 3 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 3 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 28 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in United Kingdom, Germany, Netherlands. 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 28 Feb 2014). 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?

Aggregated Pathology Score (time frame: Before and after 1 month treatment). The study lists 13 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 NCT00766415.

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 28 Feb 2014.