Study to Assess Efficacy of AZD1236 in Patients With Cystic Fibrosis
- Registration Number
- NCT00812045
- Lead Sponsor
- AstraZeneca
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- 44
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 AZD1236 - 2 Placebo -
- Primary Outcome Measures
Name Time Method Effect on biomarker levels in induced sputum 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) At inclusion, at randomisation and after 4 weeks treatment
- Secondary Outcome Measures
Name Time Method Safety and tolerability (adverse events, vital signs and laboratory safety variables) throughout study (at inclusion, randomisation, after 4 weeks treatments and at follow-up) Effect on biomarkers in blood 2 times, at baseline and after 4 weeks treatment Effect on biomarkers in urine 2 times, at baseline and after 4 weeks treatment
Trial Locations
- Locations (1)
Research Site
🇪🇸Madrid, Comunidad de Madrid, Spain