Evaluation of the Quality of Life Questionnaire-Bronchiectasis in Patients With Bronchiectasis - Full Text View

Sponsored by:	Gilead Sciences
Information provided by:	Gilead Sciences
ClinicalTrials.gov Identifier:	NCT00805025

Purpose

Over the 70-day study period, eligible patients will visit the study clinic every 2 weeks (total of 6 visits) and will receive a 28-day course of aztreonam for inhalation solution. Quality of Life questionnaires will be completed at several timepoints during the study, in additional to pulmonary function testing and other standard procedures.

Condition	Intervention	Phase
Bronchiectasis	Drug: aztreonam for inhalation solution	Phase II

Drug Information available for: Aztreonam

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Single Group Assignment
Official Title:	An Open-Label, Multicenter Trial to Validate the Quality of Life Questionnaire-Bronchiectasis and to Evaluate Perception of Symptom Improvement Following One Course of Aztreonam for Inhalation Solution (AZLI) in Subjects With Bronchiectasis and Gram-Negative Bacteria in the Airways

Further study details as provided by Gilead Sciences:

Primary Outcome Measures:

The primary objective is to determine the reliability and validity of the QOL-B. [ Time Frame: 70 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

The secondary objective is to evaluate the responsiveness of the QOL-B to perceived changes in respiratory symptoms. [ Time Frame: 70 days ] [ Designated as safety issue: No ]

Estimated Enrollment:	76
Study Start Date:	December 2008
Estimated Study Completion Date:	October 2009
Estimated Primary Completion Date:	July 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
aztreonam for inhalation solution: Experimental All eligible subjects will receive a 28-day course of aztreonam for inhalation solution. There is no comparator or placebo arm in this trial.	Drug: aztreonam for inhalation solution 75mg, via inhalation, three times daily

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Written informed consent prior to any study-related procedures
Ability to read and understand the English language
Bronchiectasis confirmed by CT scan of the chest
Previous treatment with antibiotics for bronchiectasis
Documented history of positive sputum culture for a gram-negative organism within 5 years
Positive sputum culture for a gram-negative organism at Visit 1
Male or female ≥ 18 years old

Exclusion Criteria:

Hospitalization or hemoptysis > 30 mL within 14 days of Visit 1
Antibiotic use for respiratory symptoms within 14 days of Visit 1, excluding chronic, stable azithromycin use
Change in corticosteroid or bronchodilator regimen within 14 days of Visit 1
FEV1 < 25% predicted approximately 15 minutes post-bronchodilator at Visit 1
Cigarette smoking within 6 months of Visit 1

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00805025

Contacts

Contact: Crystal Green

206-832-2132

AZLI-BX@gilead.com

Locations

United States, Arizona
	Recruiting
Phoenix, Arizona, United States, 85006

Sponsors and Collaborators

Gilead Sciences

Investigators

Study Director:

Steve Lamola, MD

Gilead Sciences

More Information

Responsible Party:	Gilead Sciences, Inc. ( Marilyn Hall, Senior Clinical Program Manager )
Study ID Numbers:	GS-US-219-0102
Study First Received:	December 5, 2008
Last Updated:	December 8, 2008
ClinicalTrials.gov Identifier:	NCT00805025
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Aztreonam
Respiratory Tract Diseases
Bronchiectasis
Quality of Life

Additional relevant MeSH terms:

Anti-Infective Agents
Anti-Bacterial Agents
Bronchial Diseases
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009