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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This study has been withdrawn prior to enrollment.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:
ClinicalTrials.gov Identifier:
NCT00812045
First Posted: December 19, 2008
Last Update Posted: May 6, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
AstraZeneca
  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
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

Resource links provided by NLM:


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 ]
  • 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 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) ]
  • Effect on biomarkers in blood [ Time Frame: 2 times, at baseline and after 4 weeks treatment ]
  • Effect on biomarkers in urine [ Time Frame: 2 times, at baseline and after 4 weeks treatment ]

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Andrew J Lockton, MD, AstraZeneca Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00812045     History of Changes
Other Study ID Numbers: D4260C00008
First Submitted: December 18, 2008
First Posted: December 19, 2008
Last Update Posted: May 6, 2009
Last Verified: May 2009

Keywords provided by AstraZeneca:
Induced sputum
cystic fibrosis
biomarker
CYBER

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