Study to Assess Efficacy of AZD1236 in Patients With Cystic Fibrosis - Full Text View

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00812045

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 II

Genetics Home Reference related topics: cystic fibrosis

MedlinePlus related topics: Cystic Fibrosis

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study
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

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:	January 2009
Estimated Study Completion Date:	November 2009
Estimated Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: AZD1236 Oral tablet, 75 mg twice daily during 4 weeks
2: Placebo Comparator	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

Contacts

Contact: AstraZeneca Clinical Study Information

800-236-9933

information.center@astrazeneca.com

Locations

Canada
Research Site
VANCOUVER, Canada
Research Site
OTTAWA, Canada
Research Site
MONTREAL, Canada
Netherlands
Research Site
AMSTERDAM, Netherlands
Research Site
GRONINGEN, Netherlands
Research Site
UTRECHT, Netherlands
Poland
Research Site
GDANSK, Poland
Research Site
POZNAN, Poland
Spain, CATALUNA
Research Site
BARCELONA, CATALUNA, Spain
Spain, Comunidad De Madrid
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:	AstraZeneca Pharmaceuticals ( Andrew J Lockton, MD )
Study ID Numbers:	D4260C00008
Study First Received:	December 18, 2008
Last Updated:	December 18, 2008
ClinicalTrials.gov Identifier:	NCT00812045
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

Study placed in the following topic categories:

Digestive System Diseases
Genetic Diseases, Inborn
Respiratory Tract Diseases
Cystic Fibrosis
Fibrosis

Lung Diseases
Infant, Newborn, Diseases
Pancreatic Diseases
Cystic fibrosis

Additional relevant MeSH terms:

Pathologic Processes

ClinicalTrials.gov processed this record on January 13, 2009