Overview

Study to Assess Efficacy of AZD1236 in Patients With Cystic Fibrosis

Status:
Withdrawn
Trial end date:
2010-08-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
AstraZeneca
Criteria
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