Cystic FibrosisPhase 2CYBERNCT00812045
Study to Assess Efficacy of AZD1236 in Patients With Cystic Fibrosis
A Phase 2 study testing AZD1236 in people with Cystic Fibrosis, run by AstraZeneca at 10 sites in 4 countries.
Trial summary
The purpose of this study is to determine the effect of AZD1236 in patients with cystic fibrosis (CF) on inflammatory biomarkers in induced sputum, after a treatment period of 4 weeks. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cystic Fibrosis
- 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
- 44 participants
- Where
- 10 sitesin 4 countries
- Study dates
- Dec 2009to Aug 2010
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provision of informed consent prior to any study specific procedures
- Have a clinical diagnosis of cystic fibrosis with an FEV1 >40% of predicted normal
- Be able to comply with induced sputum procedure
- post-menopausal surgically sterile female (total hysterectomy and /or bilateral total oophorectomy)
Who cannot join
- Concomitant diagnosis of significant pulmonary disease other than CF-related lung disease, including symptomatic asthma and allergic bronchopulmonary aspergillosis
- Treatment with any immunomodulatory agents within 8 weeks prior to Visit 2
- Known to be infected with Burkholderia cepacia
Trial locations and contacts
10 sites in 4 countries.
10 sites in 4 countries
Canada3 sites
Research Site
Montreal
Research Site
Ottawa
Research Site
Vancouver
Netherlands3 sites
Research Site
Amsterdam
Research Site
Groningen
Research Site
Utrecht
About this study
Official title: A Randomised, Double-Blind, Placebo-Controlled, Parallel Group, Phase II Study to Assess the Efficacy of 28 Day Oral Administration of AZD1236 in Adult Patients With Cystic Fibrosis
The purpose of this study is to determine the effect of AZD1236 in patients with cystic fibrosis (CF) on inflammatory biomarkers in induced sputum, after a treatment period of 4 weeks.
- Conditions
- Cystic Fibrosis
- Being tested
- AZD1236, Placebo
- Keywords
- Induced sputum, cystic fibrosis, biomarker, CYBER
- Medical subject headings
- Cystic Fibrosis
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 4 weeks
PlaceboDrug
| 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.
Effect on biomarker levels in induced sputum
Measured: 2 times at baseline and after 4 weeks treatment
Signs and symptoms (Lung function variables by spirometry, symptom scores from Diary and Health-related quality of life Questionnaire)
Measured: At inclusion, at randomisation and after 4 weeks treatment
Secondary outcomes (3)
Safety and tolerability (adverse events, vital signs and laboratory safety variables)
Measured: throughout study (at inclusion, randomisation, after 4 weeks treatments and at follow-up)
Effect on biomarkers in blood
Measured: 2 times, at baseline and after 4 weeks treatment
Effect on biomarkers in urine
Measured: 2 times, at baseline and after 4 weeks treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2008 (estimated)
- Study startDec 2009
- Study completionAug 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic FibrosisStudies 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
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Andrew J Lockton, MD, Study director, AstraZeneca R&D CharnwoodShawn Aaron, MD, Principal investigator, The Ottawa Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00812045
- Sponsor's protocol ID
- D4260C00008
- Acronym
- CYBER
- Status last verified
- May 2009
- First submitted
- 18 Dec 2008
- Last updated
- 6 May 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double-Blind, Placebo-Controlled, Parallel Group, Phase II Study to Assess the Efficacy of 28 Day Oral Administration of AZD1236 in Adult Patients With Cystic Fibrosis
- ClinicalTrials.gov ID
- NCT00812045
- Acronym / sponsor ID
- CYBER / D4260C00008
- Conditions
- Cystic Fibrosis
- Keywords
- Induced sputum, cystic fibrosis, biomarker, CYBER
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Dec 2009
- Study completion
- Aug 2010 (estimated)
- First posted
- 19 Dec 2008 (estimated)
- Results
- Not posted in the source record
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 determine the effect of AZD1236 in patients with cystic fibrosis (CF) on inflammatory biomarkers in induced sputum, after a treatment period of 4 weeks.
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
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Provision of informed consent prior to any study specific procedures
- Have a clinical diagnosis of cystic fibrosis with an FEV1 >40% of predicted normal
- Be able to comply with induced sputum procedure
- post-menopausal surgically sterile female (total hysterectomy and /or bilateral total oophorectomy)
Key exclusion criteria (3 listed)
- Concomitant diagnosis of significant pulmonary disease other than CF-related lung disease, including symptomatic asthma and allergic bronchopulmonary aspergillosis
- Treatment with any immunomodulatory agents within 8 weeks prior to Visit 2
- Known to be infected with Burkholderia cepacia
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 4 weeks | Drug | 1 |
| Placebo | Drug | 2 |
Primary outcome
Effect on biomarker levels in induced sputum
Time frame: 2 times at baseline and after 4 weeks treatment
Signs and symptoms (Lung function variables by spirometry, symptom scores from Diary and Health-related quality of life Questionnaire)
Time frame: At inclusion, at randomisation and after 4 weeks treatment
3 secondary outcomes
Safety and tolerability (adverse events, vital signs and laboratory safety variables)
Time frame: throughout study (at inclusion, randomisation, after 4 weeks treatments and at follow-up)
Effect on biomarkers in blood
Time frame: 2 times, at baseline and after 4 weeks treatment
Effect on biomarkers in urine
Time frame: 2 times, at baseline and after 4 weeks treatment
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2009.
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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.
Andrew J Lockton, MD study director
AstraZeneca R&D Charnwood
Shawn Aaron, MD principal investigator
The Ottawa Hospital
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 Cystic Fibrosis, 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 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: withdrawn, as of the sponsor's last update on 6 May 2009. 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 Canada, Netherlands, Poland, Spain. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Effect on biomarker levels in induced sputum (time frame: 2 times at baseline and after 4 weeks treatment). 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?
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 6 May 2009.