Status:
WITHDRAWN
Study to Assess Efficacy of AZD1236 in Patients With Cystic Fibrosis
Lead Sponsor:
AstraZeneca
Conditions:
Cystic Fibrosis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2010
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT00812045
Start Date
December 1 2009
End Date
August 1 2010
Last Update
May 6 2009
Active Locations (10)
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1
Research Site
Montreal, Canada
2
Research Site
Ottawa, Canada
3
Research Site
Vancouver, Canada
4
Research Site
Amsterdam, Netherlands