Study to Assess Efficacy of AZD1236 in Patients With Cystic Fibrosis

Cystic Fibrosis Clinical Trial

— CYBER  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00812045
• Other study ID #: D4260C00008
• Status: Withdrawn
• Phase: Phase 2
• First received: December 18, 2008
• Last updated: May 5, 2009
• Start date: December 2009
• Est. completion date: August 2010

Study information

• Verified date: May 2009
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health CanadaGermany: Federal Institute for Drugs and Medical DevicesNetherlands: The Central Committee on Research Involving Human Subjects (CCMO)Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsSpain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 44
• Est. completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis

Intervention

Drug:
• AZD1236
Oral tablet, 75 mg twice daily during 4 weeks
• Placebo

Locations

Country	Name	City	State
Canada	Research Site	Montreal
Canada	Research Site	Ottawa
Canada	Research Site	Vancouver
Netherlands	Research Site	Amsterdam
Netherlands	Research Site	Groningen
Netherlands	Research Site	Utrecht
Poland	Research Site	Gdansk
Poland	Research Site	Poznan
Spain	Research Site	Barcelona	Cataluna
Spain	Research Site	Madrid	Comunidad de Madrid

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

Canada,  Netherlands,  Poland,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effect on biomarker levels in induced sputum		2 times at baseline and after 4 weeks treatment	No
Primary	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	No
Secondary	Safety and tolerability (adverse events, vital signs and laboratory safety variables)		throughout study (at inclusion, randomisation, after 4 weeks treatments and at follow-up)	Yes
Secondary	Effect on biomarkers in blood		2 times, at baseline and after 4 weeks treatment	No
Secondary	Effect on biomarkers in urine		2 times, at baseline and after 4 weeks treatment	No