A Phase II , Placebo-Controlled Study to Assess Efficacy of 28 Day Oral AZD9668 in Patients With Bronchiectasis - Full Text View

A Phase II , Placebo-Controlled Study to Assess Efficacy of 28 Day Oral AZD9668 in Patients With Bronchiectasis (NEPAL)

This study has been completed.

First Received: October 6, 2008 Last Updated: April 28, 2009 History of Changes

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00769119

Purpose

The purpose of this study is to investigate if treatment with AZD9668 for 28 days is effective in treating Bronchiectasis (Brx) and if so how it compares to placebo (a substance which does not have any action).

Condition	Intervention	Phase
Bronchiectasis	Drug: AZD9668 Drug: Placebo	Phase II

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Basic Science, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Efficacy Study
Official Title:	A Phase II, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Efficacy of 28 Day Oral Administration of AZD9668 in Patients With Bronchiectasis

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

Absolute and differential neutrophil count in sputum [ Time Frame: Pre and post treatment ] [ Designated as safety issue: No ]
Signs and symptoms of Bronchiectasis [ Time Frame: Throughout the study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Safety outcome (AE's, labs, etc) [ Time Frame: Throughout the study ] [ Designated as safety issue: Yes ]
Pharmacokinetic (AZD9668 concentrations in plasma and sputum) [ Time Frame: Day 1 and 28 of treatment ] [ Designated as safety issue: No ]
Pharmacodynamic markers [ Time Frame: Day 1 and 28 of treatment ] [ Designated as safety issue: No ]

Estimated Enrollment:	40
Study Start Date:	October 2008
Study Completion Date:	April 2009

Arms	Assigned Interventions
1: Experimental	Drug: AZD9668 60 mg, oral tablet, twice daily for 28 days
2: Placebo Comparator	Drug: Placebo Match placebo to 60 mg, oral tablet, twice daily for 28 days

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Female of non child bearing potential
Clinical diagnosis of bronchiectasis
Be sputum producers, with history of chronic expectoration on most days

Exclusion Criteria:

Concomitant diagnosis of pulmonary disease other than bronchiectasis or COPD
FEV1 of <30% of predicted normal

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00769119

Locations

Canada
Research Site
Vancouver, Canada
Research Site
Calgary, Canada
Research Site
Montreal, Canada
Research Site
Ontario, Canada
Canada, Quebec
Research Site
Chemin Sainte-Foy, Quebec, Canada
United Kingdom
Research Site
Birmingham, United Kingdom
Research Site
New Castle, United Kingdom
Research Site
Cambridge, United Kingdom
Research Site
London, United Kingdom

Sponsors and Collaborators

AstraZeneca

Investigators

Principal Investigator:	Stockley, Prof	Queen Elizabeth Hospital, Birmingham, England
Study Director:	Carin Jorup	AstraZeneca R&D Lund

More Information

No publications provided

Responsible Party:	AstraZeneca Pharmaceuticals ( Carin Jorup MD, Medical Science Director, RITA EPT 4 )
Study ID Numbers:	D0520C00010
Study First Received:	October 6, 2008
Last Updated:	April 28, 2009
ClinicalTrials.gov Identifier:	NCT00769119 History of Changes
Health Authority:	Canada: Health Canada; United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by AstraZeneca:

bronchiectasis
Phase II

Study placed in the following topic categories:

Respiratory Tract Diseases
Bronchial Diseases
Bronchiectasis

Additional relevant MeSH terms:

Respiratory Tract Diseases
Bronchial Diseases
Bronchiectasis

ClinicalTrials.gov processed this record on May 07, 2009