Chronic Obstructive Pulmonary DiseasePhase 2CERANCT00758459
Safety/Tolerability Study With AZD1236 in Chronic Obstructive Pulmonary Disease (COPD) Patients
A Phase 2 study testing AZD1236 in people with Chronic Obstructive Pulmonary Disease, run by AstraZeneca at 14 sites in 5 countries.
Trial summary
The primary aim of this study is to investigate the tolerability and safety of AZD 1236 compared with placebo ("inactive substance") in COPD patients by assessment of Adverse Events, vital signs and laboratory safety assessments. 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
- 74 participants
- Where
- 14 sitesin 5 countries
- Study dates
- Sep 2008to Mar 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 reduced lung function
- 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
- Use of oral or parenteral glucocorticosteroids within 30 days prior to the study
Trial locations and contacts
14 sites in 5 countries.
14 sites in 5 countries
Hungary4 sites
Research Site
Győr
Research Site
Komló
Research Site
Pécs
Research Site
Vásárosnamény
Slovakia3 sites
Research Site
Bojnice
Research Site
Liptovský Hrádok
Research Site
Žilina
About this study
Official title: A 6 Week Double-Blind, Placebo-controlled, Randomised, Parallel Group Phase IIa Study to Assess the Tolerability/Safety and Efficacy of AZD1236as an Oral Tablet in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
The primary aim of this study is to investigate the tolerability and safety of AZD 1236 compared with placebo ("inactive substance") in COPD patients by assessment of Adverse Events, vital signs and laboratory safety assessments.
- 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 group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: AZD1236 |
| 2 | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Adverse Events
Number of patients who had an Adverse Event
Measured: all study visits
Secondary outcomes (13)
Forced Expiratory Volume in 1 Second (FEV1)
Change in FEV1 from baseline to end of treatment
Measured: Before treatment and after 1, 2, 4 and 6 weeks of treatment
Forced Vital Capacity (FVC)
Change in FVC from baseline to end of treatment
Measured: Before treatment and after 1, 2, 4 and 6 weeks of treatment
Vital Capacity (VC)
Change in VC from baseline to end of treatment
Measured: Before treatment and after 1, 2, 4 and 6 weeks of treatment
Inspiratory Capacity (IC)
Change in IC from baseline to end of treatment
Measured: Before treatment and after 1, 2, 4 and 6 weeks of treatment
Forced Expiratory Flow (FEF)25-75%
Change in FEF from baseline to end of treatment
Measured: Before treatment and after 1, 2, 4 and 6 weeks of treatment
Peak Expiratory Flow (PEF) Morning
Change in PEF from average during run-in to average during the last 4 w of treatment
Measured: Daily during run-in and treatment
Peak Expiratory Flow (PEF) Evening
Change in PEF from average during run-in to average during the last 4 w of treatment
Measured: Daily during run-in and treatment
Clinical Chronic Obstructive Pulmonary Disease (COPD) Questionnaire(CCQ) Total
Change from baseline to end of treatment in score , The total scores vary between 0 (never/not limited at all) to 6 (almost all the time/totally limited)
Measured: Before treatment and after 1, 2, 4 and 6 weeks of treatment
Clinical Chronic Obstructive Pulmonary Disease (COPD) Symptoms, Breathlessness
Change in COPD symptom, Breathlessness from average during run-in to average during the last 4 w of treatment. 5-point Likert-type scale, ranging from 0 (none) to 4 (severe)
Measured: Daily during run-in and treatment
Clinical Chronic Obstructive Pulmonary Disease (COPD) Symptoms, Chest Tightness
Change in COPD symptom, chest tightness from average during run-in to average during the last 4 w of treatment, 5-point Likert-type scale, ranging from 0 (none) to 4 (severe)
Measured: Daily during run-in and treatment
Clinical Chronic Obstructive Pulmonary Disease (COPD) Symptoms, Cough Score
Change in COPD symptoms, cough score from average during run-in to average during the last 4 w of treatment, 5-point Likert-type scale, ranging from 0 (none) to 4 (severe)
Measured: Daily during run-in and treatment
Clinical Chronic Obstructive Pulmonary Disease (COPD) Symptoms, Night Time Awakenings
Change in night time awakenings from average during run-in to average during the last 4 w of treatment, 5-point Likert-type scale, ranging from 0 (none) to 4 (severe)
Measured: Daily during run-in and treatment
6-minute Walk Test
Change from baseline to end of treatment
Measured: Before treatment and after 6 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2008 (estimated)
- Study startSep 2008
- Study completionMar 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
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Helgo Magnussen, MD, Professor, Principal investigator, Pulmonary research institute at Hospital Grosshansdorf, Wöhrendamm, Grosshansdorf GermanyAndrew Lockton, MD, Study director, AstraZeneca R&D Charnwood
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00758459
- Sponsor's protocol ID
- D4260C00003
- Acronym
- CERA
- Status last verified
- Jul 2011
- First submitted
- 23 Sep 2008
- Last updated
- 19 Aug 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 6 Week Double-Blind, Placebo-controlled, Randomised, Parallel Group Phase IIa Study to Assess the Tolerability/Safety and Efficacy of AZD1236as an Oral Tablet in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
- ClinicalTrials.gov ID
- NCT00758459
- Acronym / sponsor ID
- CERA / D4260C00003
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- COPD
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Sep 2008
- Study completion
- Mar 2009 (actual)
- First posted
- 25 Sep 2008 (estimated)
- Results
- Posted 19 Aug 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary aim of this study is to investigate the tolerability and safety of AZD 1236 compared with placebo ("inactive substance") in COPD patients by assessment of Adverse Events, vital signs and laboratory safety assessments.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: AZD1236 |
| 2 | 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 (4 listed)
- Diagnosis of COPD for 1 month
- Men or postmenopausal women
- Spirometry values indicating reduced lung function
- Smoking history equivalent to using 20 cigarettes a day for 10 years
Key exclusion criteria (3 listed)
- Any current respiratory tract disorders other than COPD
- Requirement for regular oxygen therapy
- Use of oral or parenteral glucocorticosteroids within 30 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 | 1 |
| PlaceboDosing to match AZD1236 | Drug | 2 |
Primary outcome
Incidence of Adverse Events
Time frame: all study visits
Number of patients who had an Adverse Event
13 secondary outcomes
Forced Expiratory Volume in 1 Second (FEV1)
Time frame: Before treatment and after 1, 2, 4 and 6 weeks of treatment
Forced Vital Capacity (FVC)
Time frame: Before treatment and after 1, 2, 4 and 6 weeks of treatment
Vital Capacity (VC)
Time frame: Before treatment and after 1, 2, 4 and 6 weeks of treatment
Inspiratory Capacity (IC)
Time frame: Before treatment and after 1, 2, 4 and 6 weeks of treatment
Forced Expiratory Flow (FEF)25-75%
Time frame: Before treatment and after 1, 2, 4 and 6 weeks of treatment
Peak Expiratory Flow (PEF) Morning
Time frame: Daily during run-in and treatment
Peak Expiratory Flow (PEF) Evening
Time frame: Daily during run-in and treatment
Clinical Chronic Obstructive Pulmonary Disease (COPD) Questionnaire(CCQ) Total
Time frame: Before treatment and after 1, 2, 4 and 6 weeks of treatment
Clinical Chronic Obstructive Pulmonary Disease (COPD) Symptoms, Breathlessness
Time frame: Daily during run-in and treatment
Clinical Chronic Obstructive Pulmonary Disease (COPD) Symptoms, Chest Tightness
Time frame: Daily during run-in and treatment
Clinical Chronic Obstructive Pulmonary Disease (COPD) Symptoms, Cough Score
Time frame: Daily during run-in and treatment
Clinical Chronic Obstructive Pulmonary Disease (COPD) Symptoms, Night Time Awakenings
Time frame: Daily during run-in and treatment
6-minute Walk Test
Time frame: Before treatment and after 6 weeks of treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Helgo Magnussen, MD, Professor principal investigator
Pulmonary research institute at Hospital Grosshansdorf, Wöhrendamm, Grosshansdorf Germany
Andrew Lockton, MD study director
AstraZeneca R&D Charnwood
14 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 AZD1236 in people with Chronic Obstructive Pulmonary Disease, run by AstraZeneca at 14 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 4 inclusion and 3 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 19 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Hungary, Finland, Slovakia, Bulgaria, Germany. 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 19 Aug 2011). 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?
Incidence of Adverse Events (time frame: all study visits). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Aug 2011.