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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT00805025
First received: December 5, 2008
Last updated: February 3, 2014
Last verified: February 2014
Results First Received: September 9, 2013  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Bronchiectasis
Intervention: Drug: AZLI

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants were enrolled at a total of 21 study sites in the United States. The first participant was screened on 08 December 2008. The last participant observation was on 14 October 2009.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
131 participants were screened and 89 were enrolled and treated.

Reporting Groups
  Description
AZLI Participants were evaluated beginning 14 days prior to starting a 28-day course of aztreonam for inhalation solution (AZLI) 75 mg three times daily via investigational nebulizer (Day 0 to Day 28), followed by post-treatment assessments every 14 days through Day 56, for a total of 70 days of participation in the study.

Participant Flow:   Overall Study
    AZLI  
STARTED     131  
Enrolled and Treated     89  
COMPLETED     82  
NOT COMPLETED     49  
Screened but not enrolled/treated                 42  
Adverse Event                 4  
Withdrawal by Subject                 2  
Physician Decision                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Enrolled and treated participants

Reporting Groups
  Description
AZLI Participants were evaluated beginning 14 days prior to starting a 28-day course of AZLI 75 mg three times daily via investigational nebulizer (Day 0 to Day 28), followed by post-treatment assessments every 14 days through Day 56, for a total of 70 days of participation in the study.

Baseline Measures
    AZLI  
Number of Participants  
[units: participants]
  89  
Age  
[units: years]
Mean ± Standard Deviation
  64  ± 14.7  
Gender  
[units: participants]
 
Female     62  
Male     27  
Race/Ethnicity, Customized  
[units: participants]
 
Asian     2  
African-American     3  
White     84  



  Outcome Measures
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1.  Primary:   Reliability of the Respiratory Domain of the Quality of Life Questionnaire-Bronchiectasis (QOL-B)   [ Time Frame: Day -14 to Day 0 ]

2.  Primary:   Convergent Validity of the Respiratory Domain of the QOL-B   [ Time Frame: Day -14 ]

3.  Secondary:   Responsiveness of the Respiratory Domain of the QOL-B as Assessed by the Anchor-based Minimal Clinically Important Difference (MCID) Following Categorization of Level of Change Using the Global Rating of Change Questionnaire (GRCQ)   [ Time Frame: Day 0 to Day 28 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Clinical Trial Disclosures
Organization: Gilead Sciences, Inc.
e-mail: ClinicalTrialDisclosures@gilead.com


No publications provided


Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT00805025     History of Changes
Other Study ID Numbers: GS-US-219-0102
Study First Received: December 5, 2008
Results First Received: September 9, 2013
Last Updated: February 3, 2014
Health Authority: United States: Food and Drug Administration