Study to Assess Efficacy of AZD1236 in Patients With Cystic Fibrosis (CYBER)

AstraZeneca

Status and phase: Withdrawn; Phase 2

Conditions: Cystic Fibrosis

Treatments: Drug: Placebo; Drug: AZD1236

Study type: Interventional

Funder types: Industry

Identifiers

NCT00812045

D4260C00008

Details and patient eligibility

About

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.

Enrollment: 44 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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44 participants in 2 patient groups, including a placebo group

1

Experimental group

Treatment:

Drug: AZD1236

2

Placebo Comparator group

Treatment:

Drug: Placebo