Study to Assess Efficacy of AZD1236 in Patients With Cystic Fibrosis

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

Status

Withdrawn

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00812045

Acronym

CYBER

Enrollment

Registered

2008-12-19

Start date

2009-12-31

Completion date

2010-08-31

Last updated

2009-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cystic Fibrosis

Keywords

Induced sputum, cystic fibrosis, biomarker, CYBER

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.

Interventions

DRUGAZD1236

Oral tablet, 75 mg twice daily during 4 weeks

DRUGPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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

Countries

Canada, Netherlands, Poland, Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026