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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00812045 |
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Date of registration:
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18/12/2008 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Study to Assess Efficacy of AZD1236 in Patients With Cystic Fibrosis
CYBER |
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Scientific title:
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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 |
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Date of first enrolment:
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December 2009 |
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Target sample size:
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44 |
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Recruitment status: |
Withdrawn |
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URL:
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http://clinicaltrials.gov/show/NCT00812045 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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Phase:
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Phase 2
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Countries of recruitment
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Canada
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Netherlands
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Poland
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Spain
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Contacts
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Name:
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Andrew J Lockton, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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AstraZeneca R&D Charnwood |
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Name:
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Shawn Aaron, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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The Ottawa Hospital |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Cystic Fibrosis
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Intervention(s)
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Drug: Placebo
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Drug: AZD1236
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Primary Outcome(s)
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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]
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Effect on biomarker levels in induced sputum
[Time Frame: 2 times at baseline and after 4 weeks treatment]
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Secondary Outcome(s)
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Effect on biomarkers in blood
[Time Frame: 2 times, at baseline and after 4 weeks treatment]
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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)]
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Effect on biomarkers in urine
[Time Frame: 2 times, at baseline and after 4 weeks treatment]
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Secondary ID(s)
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D4260C00008
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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