Chronic Obstructive Pulmonary DiseasePhase 2BICONCT00758706

A Phase IIa Study Assessing the Effects of AZD1236 on Biomarkers in Chronic Obstructive Pulmonary Disease (COPD) Patients

A Phase 2 study testing AZD1236 in people with Chronic Obstructive Pulmonary Disease, run by AstraZeneca at 10 sites in 4 countries.

Completed

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

Official record

Search all trials

Trial summary

The primary aim of this study is to investigate the effects of AZD1236 compared with placebo ("inactive substance") in COPD patients by analysing biomarkers for inflammation and tissue degradation in blood, urine and sputum. 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?: AZD1236
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 55 participants
Where: 10 sitesin 4 countries
Study dates: Sep 2008to May 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

Diagnosis of COPD for 1 month
Men or postmenopausal women
Spirometry values indicating symptomatic patients
Smoking history equivalent to using 20 cigarettes a day for 10 years.

Who cannot join

Any current respiratory tract disorders other than COPD
Requirement for regular oxygen therapy
Acute worsening of COPD (exacerbation) 1,5 month prior to study drug administration
Use of oral or parenteral glucocorticosteroids within 30 days and use of inhaled steroids 14 days prior to the study

Trial locations and contacts

10 sites in 4 countries.

Country

City, postcode or hospital

10 sites in 4 countries

Denmark4 sites

Research Site
Aalborg
Research Site
Arhus C
Research Site
København NV
Research Site
Odense C

Other trials in Denmark

Finland2 sites

Research Site
Helsinki
Research Site
Tampere

Other trials in Finland

Netherlands2 sites

Research Site
Eindhoven
Research Site
Nieuwegein

Other trials in Netherlands

Norway2 sites

Research Site
Oslo
Research Site
Trondheim

Other trials in Norway

About this study

Official title: A Double-blind, Randomised, Placebo-controlled, Parallel Group Multi-centre Phase IIa Study to Assess the Effects on Biomarkers in Induced Sputum, Bood and Uine of AZD1236 Administered as Oral Tablet in Moderate to Severe COPD Patients During a 6 Week Period.

Conditions: Chronic Obstructive Pulmonary Disease
Being tested: AZD1236, 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.

AZD1236Drug
oral tablet, 75 mg, twice daily during 6 weeks
PlaceboDrug
Dosing to match AZD1236

Study groups in NCT00758706
Study group	Role	What they receive
AZD1236	Experimental	oral tablet, 75 mg, twice daily during 6 weeks Receives: Drug: AZD1236
Placebo	Placebo comparator	Dosing to match AZD1236 Receives: Drug: Placebo

What is being measured

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

Ratio of TNF Alpha at Week 6 to Baseline
Ratio reflects Sputum Tumor Necrosis Factor alpha (TNF alpha) at week 6 value divide by baseline value. Baseline is geometric mean of Visit 2 (last value during run-in) and Visit 3 (Randomization).
Measured: Baseline and Week 6
Ratio of Sputum Total Cells at Week 6 to Baseline
Ratio reflects Sputum Total Cells at week 6 value divide by baseline value. Baseline is geometric mean of Visit 2 (last value during run-in) and Visit 3 (Randomization).
Measured: Baseline and Week 6
Ratio of Total Urine Desmosine at Week 6 to Baseline
Ratio reflects Total Urine Desmosine at week 6 value divide by baseline value. Baseline is visit 3(Randomization) value.
Measured: Baseline and Week 6

Secondary outcomes (13)

Incidence of Adverse Events
Number of patients who had an AE
Measured: all study visits
Change From Baseline in Forced Expiratory Volume (FEV1) at Week 6
Change from baseline reflects the Week 6 value minus the baseline value. Baseline is visit 3(randomization) value.
Measured: Baseline and Week 6
Change From Baseline in Forced Vital Capacity (FVC) at Week 6
Change from baseline reflects the Week 6 value minus the baseline value. Baseline is visit 3(randomization) value.
Measured: Baseline and Week 6
Change From Baseline in Vital Capacity (VC) at Week 6
Change from baseline reflects the Week 6 value minus the baseline value. Baseline is visit 3(randomization) value.
Measured: Baseline and Week 6
Change From Baseline in Inspiratory Capacity (IC) at Week 6
Change from baseline reflects the Week 6 value minus the baseline value. Baseline is visit 3(randomization) value.
Measured: Baseline and Week 6
Change From Baseline in Forced Expiratory Flow (FEF) 25-75% at Week 6
Change from baseline reflects the Week 6 value minus the baseline value. Baseline is visit 3(randomization) value.
Measured: Baseline and Week 6
Change From Baseline in Peak Expiratory Flow (PEF) Morning at Average of Last 4 Week Treatment
Change from baseline reflects the average of last 4 week on treatment (Week 1, Week 2, Week 4 and Week 6) minus the baseline value. Baseline is the mean of the last 10 days of data during run-in.
Measured: Baseline and last 4 week on treatment(Week 1, Week 2, Week 4 and Week 6)
Change From Baseline in Peak Expiratory Flow (PEF) Evening at Average of Last 4 Week Treatment
Change from baseline reflects the average of last 4 week on treatment (Week 1, Week 2, Week 4 and Week 6) minus the baseline value. Baseline is the mean of the last 10 days of data during run-in.
Measured: Baseline and last 4 week on treatment(Week 1, Week 2, Week 4 and Week 6)
Change From Baseline in Clinical COPD Questionnaire(CCQ) Total
Change from baseline reflects the Week 6 value minus the baseline value. Baseline is visit 3(randomization) value. The total scores vary between 0 (never/not limited at all) to 6 (almost all the time/totally limited)
Measured: Baseline and Week 6
Change From Baseline in COPD Symptoms, Breathlessness at Average of Last 4 Week Treatment
Change from baseline reflects the average of last 4 week on treatment (Week 1, Week 2, Week 4 and Week 6) minus the baseline value. Baseline is the mean of the last 10 days of data during run-in. Score vary between 0 (None) to 4 (Severe).
Measured: Baseline and last 4 week on treatment(Week 1, Week 2, Week 4 and Week 6)
Change From Baseline in COPD Symptoms, Chest Tightness at Average of Last 4 Week Treatment
Change from baseline reflects the average of last 4 week on treatment (Week 1, Week 2, Week 4 and Week 6) minus the baseline value. Baseline is the mean of the last 10 days of data during run-in. Score vary between 0 (None) to 4 (Severe).
Measured: Baseline and last 4 week on treatment(Week 1, Week 2, Week 4 and Week 6)
Change From Baseline in COPD Symptoms, Cough Score at Average of Last 4 Week Treatment
Change from baseline reflects the average of last 4 week on treatment (Week 1, Week 2, Week 4 and Week 6) minus the baseline value. Baseline is the mean of the last 10 days of data during run-in. Score vary between 0 (None) to 4 (Almost Constant).
Measured: Baseline and last 4 week on treatment(Week 1, Week 2, Week 4 and Week 6)
Change From Baseline in COPD Symptoms, Night Time Awakenings at Average of Last 4 Week Treatment
Change from baseline reflects the average of last 4 week on treatment (Week 1, Week 2, Week 4 and Week 6) minus the baseline value. Baseline is the mean of the last 10 days of data during run-in. Score vary between 0 (None) to 4 (Almost Constant).
Measured: Baseline and last 4 week on treatment(Week 1, Week 2, Week 4 and Week 6)

Timeline

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

Sep 2008May 2009

First posted25 Sep 2008 (estimated)
Study startSep 2008
Primary completionMay 2009
Study completionMay 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: Double blind
Who is masked: Participant, Investigator
Enrolment: 55 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00758706
Sponsor's protocol ID: D4260C00007
Acronym: BICO
Status last verified: Apr 2015
First submitted: 23 Sep 2008
Last updated: 16 Apr 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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

Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
RecruitingPhase 3
A Study to Investigate the Efficacy and Safety of Belumosudil Compared With Best Available Therapy in Participants Aged 12 Years or Older With Chronic Graft-versus-host Disease
Chronic Graft Versus Host Disease

All Chronic Obstructive Pulmonary Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Double-blind, Randomised, Placebo-controlled, Parallel Group Multi-centre Phase IIa Study to Assess the Effects on Biomarkers in Induced Sputum, Bood and Uine of AZD1236 Administered as Oral Tablet in Moderate to Severe COPD Patients During a 6 Week Period.
ClinicalTrials.gov ID: NCT00758706
Acronym / sponsor ID: BICO / D4260C00007
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: COPD
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 55 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: Sep 2008
Primary completion: May 2009 (actual)
Study completion: May 2009 (actual)
First posted: 25 Sep 2008 (estimated)
Results: Posted 16 Apr 2015

Clinical summary

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
AZD1236	Experimental	Drug: AZD1236oral tablet, 75 mg, twice daily during 6 weeks
Placebo	Placebo comparator	Drug: PlaceboDosing to match AZD1236

Who may qualify

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

Key inclusion criteria (4 listed)

Diagnosis of COPD for 1 month
Men or postmenopausal women
Spirometry values indicating symptomatic patients
Smoking history equivalent to using 20 cigarettes a day for 10 years.

Key exclusion criteria (4 listed)

Any current respiratory tract disorders other than COPD
Requirement for regular oxygen therapy
Acute worsening of COPD (exacerbation) 1,5 month prior to study drug administration
Use of oral or parenteral glucocorticosteroids within 30 days and use of inhaled steroids 14 days prior to the study

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
AZD1236oral tablet, 75 mg, twice daily during 6 weeks	Drug	AZD1236
PlaceboDosing to match AZD1236	Drug	Placebo

Primary outcome

Ratio of TNF Alpha at Week 6 to Baseline
Time frame: Baseline and Week 6
Ratio reflects Sputum Tumor Necrosis Factor alpha (TNF alpha) at week 6 value divide by baseline value. Baseline is geometric mean of Visit 2 (last value during run-in) and Visit 3 (Randomization).
Ratio of Sputum Total Cells at Week 6 to Baseline
Time frame: Baseline and Week 6
Ratio reflects Sputum Total Cells at week 6 value divide by baseline value. Baseline is geometric mean of Visit 2 (last value during run-in) and Visit 3 (Randomization).
Ratio of Total Urine Desmosine at Week 6 to Baseline
Time frame: Baseline and Week 6
Ratio reflects Total Urine Desmosine at week 6 value divide by baseline value. Baseline is visit 3(Randomization) value.

13 secondary outcomes

Incidence of Adverse Events
Time frame: all study visits
Change From Baseline in Forced Expiratory Volume (FEV1) at Week 6
Time frame: Baseline and Week 6
Change From Baseline in Forced Vital Capacity (FVC) at Week 6
Time frame: Baseline and Week 6
Change From Baseline in Vital Capacity (VC) at Week 6
Time frame: Baseline and Week 6
Change From Baseline in Inspiratory Capacity (IC) at Week 6
Time frame: Baseline and Week 6
Change From Baseline in Forced Expiratory Flow (FEF) 25-75% at Week 6
Time frame: Baseline and Week 6
Change From Baseline in Peak Expiratory Flow (PEF) Morning at Average of Last 4 Week Treatment
Time frame: Baseline and last 4 week on treatment(Week 1, Week 2, Week 4 and Week 6)
Change From Baseline in Peak Expiratory Flow (PEF) Evening at Average of Last 4 Week Treatment
Time frame: Baseline and last 4 week on treatment(Week 1, Week 2, Week 4 and Week 6)
Change From Baseline in Clinical COPD Questionnaire(CCQ) Total
Time frame: Baseline and Week 6
Change From Baseline in COPD Symptoms, Breathlessness at Average of Last 4 Week Treatment
Time frame: Baseline and last 4 week on treatment(Week 1, Week 2, Week 4 and Week 6)
Change From Baseline in COPD Symptoms, Chest Tightness at Average of Last 4 Week Treatment
Time frame: Baseline and last 4 week on treatment(Week 1, Week 2, Week 4 and Week 6)
Change From Baseline in COPD Symptoms, Cough Score at Average of Last 4 Week Treatment
Time frame: Baseline and last 4 week on treatment(Week 1, Week 2, Week 4 and Week 6)
Change From Baseline in COPD Symptoms, Night Time Awakenings at Average of Last 4 Week Treatment
Time frame: Baseline and last 4 week on treatment(Week 1, Week 2, Week 4 and Week 6)

Results and safety

Results posted to the registry on 16 Apr 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
AZD1236	26	22
Placebo	29	25

Primary outcome: Ratio of TNF Alpha at Week 6 to Baseline

Time frame: Baseline and Week 6. Mean (Full Range). Unit: ratio

Measure	AZD1236 n = 23	Placebo n = 27
Value	1.37 (0.532)	1.21 (0.270)

Population analysed: Full analysis set excluded participants without baseline or post-baseline data.

Primary outcome: Ratio of Sputum Total Cells at Week 6 to Baseline

Time frame: Baseline and Week 6. Mean (Full Range). Unit: ratio

Measure	AZD1236 n = 23	Placebo n = 27
Value	1.07 (0.209)	0.876 (0.002)

Population analysed: Full analysis set excluded participants without baseline or post-baseline data.

Primary outcome: Ratio of Total Urine Desmosine at Week 6 to Baseline

Time frame: Baseline and Week 6. Mean (Full Range). Unit: ratio

Measure	AZD1236 n = 24	Placebo n = 28
Value	0.946 (0.240)	1.27 (0.387)

Population analysed: Full analysis set excluded participants without baseline or post-baseline data.

13 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
AZD1236	4 of 26 (15.4%)	7 of 26 (26.9%)	Not reported
Placebo	0 of 29 (0%)	10 of 29 (34.5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related InfoLink provided by the sponsor.
D4260C00007Link provided by the sponsor.

Related trials for Chronic Obstructive Pulmonary Disease

Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
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Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
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RecruitingPhase 3
A Study to Investigate the Efficacy and Safety of Belumosudil Compared With Best Available Therapy in Participants Aged 12 Years or Older With Chronic Graft-versus-host Disease
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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.

Ronald Dahl, MD, Professor principal investigator

Arhus Kommune HospitalMedicinsk

Andrew Lockton, MD study director

AstraZeneca R&D Charnwood

10 sites in 4 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing AZD1236 in people with Chronic Obstructive Pulmonary Disease, run by AstraZeneca at 10 sites in 4 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 4 inclusion and 4 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 16 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in Denmark, Finland, Netherlands, Norway. 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 16 Apr 2015). 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?

Ratio of TNF Alpha at Week 6 to Baseline (time frame: Baseline and Week 6). The study lists 3 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 NCT00758706.

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 16 Apr 2015; AzTrials last refreshed its copy on 6 Nov 2026.