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

May 5, 2009 updated by: AstraZeneca

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

44

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
      • Montreal, Canada
        • Research Site
      • Ottawa, Canada
        • Research Site
      • Vancouver, Canada
        • Research Site
  • Netherlands
      • Amsterdam, Netherlands
        • Research Site
      • Groningen, Netherlands
        • Research Site
      • Utrecht, Netherlands
        • Research Site
  • Poland
      • Gdansk, Poland
        • Research Site
      • Poznan, Poland
        • Research Site
  • Spain
    • Cataluna
      • Barcelona, Cataluna, Spain
        • Research Site
    • Comunidad de Madrid
      • Madrid, Comunidad de Madrid, Spain
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Effect on biomarker levels in induced sputum
Time Frame: 2 times at baseline and after 4 weeks treatment
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
At inclusion, at randomisation and after 4 weeks treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
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)
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
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
2 times, at baseline and after 4 weeks treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

  • Study Director: Andrew J Lockton, MD, AstraZeneca R&D Charnwood
  • Principal Investigator: Shawn Aaron, MD, The Ottawa Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2009

Study Completion (Anticipated)

August 1, 2010

Study Registration Dates

First Submitted

December 18, 2008

First Submitted That Met QC Criteria

December 18, 2008

First Posted (Estimate)

December 19, 2008

Study Record Updates

Last Update Posted (Estimate)

May 6, 2009

Last Update Submitted That Met QC Criteria

May 5, 2009

Last Verified

May 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D4260C00008

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cystic Fibrosis

Clinical Trials on Placebo

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Serbia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe