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

Sponsor

AstraZeneca (Industry)

Overall Status

Withdrawn

CT.gov ID

NCT00812045

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

4.4

Patients Per Site

0.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cystic Fibrosis	Drug: AZD1236 Drug: Placebo	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

44 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

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

Study Start Date :

Dec 1, 2009

Anticipated Study Completion Date :

Aug 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1	Drug: AZD1236 Oral tablet, 75 mg twice daily during 4 weeks
Placebo Comparator: 2	Drug: Placebo

Arm

Intervention/Treatment

Experimental: 1

Drug: AZD1236

Oral tablet, 75 mg twice daily during 4 weeks

Placebo Comparator: 2

Drug: Placebo

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country
1	Research Site	Montreal		Canada
2	Research Site	Ottawa		Canada
3	Research Site	Vancouver		Canada
4	Research Site	Amsterdam		Netherlands
5	Research Site	Groningen		Netherlands
6	Research Site	Utrecht		Netherlands
7	Research Site	Gdansk		Poland
8	Research Site	Poznan		Poland
9	Research Site	Barcelona	Cataluna	Spain
10	Research Site	Madrid	Comunidad de Madrid	Spain