Status:

COMPLETED

Evaluation of the Quality of Life Questionnaire-Bronchiectasis (QOL-B) in Patients With Bronchiectasis

Lead Sponsor:

Gilead Sciences

Conditions:

Bronchiectasis

Eligibility:

All Genders

18+ years

Phase:

PHASE2

Brief Summary

Over the 70-day study period, eligible patients visited the study clinic every 2 weeks (total of 6 visits) and received a 28-day course of aztreonam for inhalation solution (AZLI). The Quality of Life...

Eligibility Criteria

Inclusion

  • 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 first visit (Day -14)

Exclusion

  • Hospitalization or hemoptysis \> 30 mL within 14 days of first visit (Day -14)
  • Antibiotic use for respiratory symptoms within 14 days of first visit (Day -14), excluding chronic, stable azithromycin use
  • Change in corticosteroid or bronchodilator regimen within 14 days of first visit (Day -14)
  • Forced expiratory volume in 1 second (FEV1) \< 25% predicted approximately 15 minutes following use of a bronchodilator at first visit (Day -14)
  • Cigarette smoking within 6 months of first visit (Day -14)

Key Trial Info

Start Date :

December 1 2008

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

October 1 2009

Estimated Enrollment :

89 Patients enrolled

Trial Details

Trial ID

NCT00805025

Start Date

December 1 2008

End Date

October 1 2009

Last Update

March 20 2014

Active Locations (24)

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Page 1 of 6 (24 locations)

1

Birmingham, Alabama, United States, 35209

2

Peoria, Arizona, United States, 85381

3

Phoenix, Arizona, United States, 85006

4

Orange, California, United States, 92868