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

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00812045
First received: December 18, 2008
Last updated: May 5, 2009
Last verified: May 2009
History of Changes
  Purpose

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 Intervention Phase
Cystic Fibrosis
 Drug: AZD1236
Drug: Placebo
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:

MedlinePlus related topics: Cystic Fibrosis
U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Effect on biomarker levels in induced sputum [ Time Frame: 2 times at baseline and after 4 weeks treatment ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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) ] [ Designated as safety issue: Yes ]
  • Effect on biomarkers in blood [ Time Frame: 2 times, at baseline and after 4 weeks treatment ] [ Designated as safety issue: No ]
  • Effect on biomarkers in urine [ Time Frame: 2 times, at baseline and after 4 weeks treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 44
Study Start Date: December 2009
Estimated Study Completion Date: August 2010
Arms Assigned Interventions
Experimental: 1 Drug: AZD1236
Oral tablet, 75 mg twice daily during 4 weeks
Placebo Comparator: 2 Drug: Placebo

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00812045

Locations
Canada
Research Site
Montreal, Canada
Research Site
Ottawa, Canada
Research Site
Vancouver, Canada
Netherlands
Research Site
Amsterdam, Netherlands
Research Site
Groningen, Netherlands
Research Site
Utrecht, Netherlands
Poland
Research Site
Gdansk, Poland
Research Site
Poznan, Poland
Spain
Research Site
Barcelona, Cataluna, Spain
Research Site
Madrid, Comunidad de Madrid, Spain
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Andrew J Lockton, MD AstraZeneca R&D Charnwood
Principal Investigator: Shawn Aaron, MD The Ottawa Hospital
  More Information

No publications provided

Responsible Party: Andrew J Lockton, MD, AstraZeneca Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00812045     History of Changes
Other Study ID Numbers: D4260C00008
Study First Received: December 18, 2008
Last Updated: May 5, 2009
Health Authority: Canada: Health Canada
Germany: Federal Institute for Drugs and Medical Devices
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Spain: Spanish Agency of Medicines

Keywords provided by AstraZeneca:
Induced sputum
cystic fibrosis
biomarker
CYBER

Additional relevant MeSH terms:
Cystic Fibrosis
Fibrosis
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
 Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 23, 2013