Back to resultsStudy to Assess Efficacy of AZD1236 in Patients With Cystic Fibrosis (CYBER)
Primary Purpose
Cystic Fibrosis
Status
Withdrawn
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
AZD1236
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Cystic Fibrosis focused on measuring Induced sputum, cystic fibrosis, biomarker, CYBER
Eligibility 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
Sites / Locations
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
1
2
Arm Description
Outcomes
Primary Outcome Measures
Effect on biomarker levels in induced sputum
Signs and symptoms (Lung function variables by spirometry, symptom scores from Diary and Health-related quality of life Questionnaire)
Secondary Outcome Measures
Safety and tolerability (adverse events, vital signs and laboratory safety variables)
Effect on biomarkers in blood
Effect on biomarkers in urine
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00812045
Brief Title
Study to Assess Efficacy of AZD1236 in Patients With Cystic Fibrosis
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2009
Overall Recruitment Status
Withdrawn
Study Start Date
December 2009 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2010 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
AstraZeneca
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cystic Fibrosis
Keywords
Induced sputum, cystic fibrosis, biomarker, CYBER
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
44 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
AZD1236
Intervention Description
Oral tablet, 75 mg twice daily during 4 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Effect on biomarker levels in induced sputum
Time Frame
2 times at baseline and after 4 weeks treatment
Title
Signs and symptoms (Lung function variables by spirometry, symptom scores from Diary and Health-related quality of life Questionnaire)
Time Frame
At inclusion, at randomisation and after 4 weeks treatment
Secondary Outcome Measure Information:
Title
Safety and tolerability (adverse events, vital signs and laboratory safety variables)
Time Frame
throughout study (at inclusion, randomisation, after 4 weeks treatments and at follow-up)
Title
Effect on biomarkers in blood
Time Frame
2 times, at baseline and after 4 weeks treatment
Title
Effect on biomarkers in urine
Time Frame
2 times, at baseline and after 4 weeks treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew J Lockton, MD
Organizational Affiliation
AstraZeneca R&D Charnwood
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Shawn Aaron, MD
Organizational Affiliation
The Ottawa Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Research Site
City
Montreal
Country
Canada
Facility Name
Research Site
City
Ottawa
Country
Canada
Facility Name
Research Site
City
Vancouver
Country
Canada
Facility Name
Research Site
City
Amsterdam
Country
Netherlands
Facility Name
Research Site
City
Groningen
Country
Netherlands
Facility Name
Research Site
City
Utrecht
Country
Netherlands
Facility Name
Research Site
City
Gdansk
Country
Poland
Facility Name
Research Site
City
Poznan
Country
Poland
Facility Name
Research Site
City
Barcelona
State/Province
Cataluna
Country
Spain
Facility Name
Research Site
City
Madrid
State/Province
Comunidad de Madrid
Country
Spain
12. IPD Sharing Statement
Learn more about this trial
Study to Assess Efficacy of AZD1236 in Patients With Cystic Fibrosis
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