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

December 5, 2008
February 3, 2014
December 2008
October 2009   (final data collection date for primary outcome measure)
  • Reliability of the Respiratory Domain of the Quality of Life Questionnaire-Bronchiectasis (QOL-B) [ Time Frame: Day -14 to Day 0 ] [ Designated as safety issue: No ]

    Test-retest reliability is a measure of the stability or reproducibility of a measure over a period of time during which status on the underlying construct has not changed, and is measured by the intraclass correlation of scores obtained at 2 time points within that period. Test-retest reliability of respiratory symptoms was calculated for response at Day -14 and Day 0. Reliability of the participants' QOL-B responses was assessed from an Intraclass Correlation Coefficient (ICC). A score of ≥ 0.70 would indicate strong reliability.

    The QOL-B respiratory symptoms score was transformed onto a scale of 0-100, with higher scores representing a better quality of life.

  • Convergent Validity of the Respiratory Domain of the QOL-B [ Time Frame: Day -14 ] [ Designated as safety issue: No ]
    Convergent validity was assessed at Day -14 by examining the correlations between relevant QOL-B domains and other indicators of health status: a bronchiectasis severity score based on high-resolution computerised tomography (HRCT) scan results, forced expiratory volume in 1 second (FEV1) percent predicted, 6-minute walk test (6MWT) results, and St. George's Respiratory Questionnaire (SGRQ) symptoms scores. Correlations with absolute values of 0.30 to 0.50 indicated moderate evidence of convergent validity.
The primary objective is to determine the reliability and validity of the QOL-B. [ Time Frame: 70 days ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00805025 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: No ]

The anchor-based method measured the participant's perception of change at Day 28 using the GRCQ, which assesses improving/worsening symptoms. Distribution of ratings was categorized as no change (-1 to 1), minimal change (≥ 1.1 to < 3.1 or ≤ -1.1 to > -3.1), moderate change (≥ 3.1 to < 5.1 or ≤ -3.1 to > -5.1) or large change (≥ 5.1, ≤ -5.1). The GRCQ evaluated change in respiratory symptoms on a visual analog scale from -7 (worsening) to +7 (improvement). The following algorithm was used to obtain the mean change:

If the corresponding GRCQ score was in the "no change" group, then change from baseline QOL-B = Observed QOL-B change from baseline score; if > 1, then change from baseline QOL-B score = Observed QOL-B change from baseline score; if < -1, the change from baseline QOL-B score = (-1) * Observed QOL-B change from baseline score.

Then the mean change from baseline of QOL-B respiratory symptoms score of the minimal change category group is the anchor-based MCID.

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 ]
Not Provided
Not Provided
 
Evaluation of the Quality of Life Questionnaire-Bronchiectasis (QOL-B) in Patients With Bronchiectasis
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

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-Bronchiectasis (QOL-B) questionnaire was completed at several time points during the study, in additional to pulmonary function testing and other standard procedures.

Not Provided
Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Bronchiectasis
Drug: AZLI
75 mg aztreonam for inhalation solution (AZLI), administered 3 times daily using the PARI Investigational eFlow® Nebulizer System (with a minimum of 4 hours between doses) following administration of a short-acting bronchodilator
Other Name: Cayston®
Experimental: AZLI
Participants were evaluated beginning 14 days prior to starting a 28-day course of AZLI (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.
Intervention: Drug: AZLI
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
89
October 2009
October 2009   (final data collection date for primary outcome measure)

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 first visit (Day -14)

Exclusion Criteria:

  • 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)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00805025
GS-US-219-0102
No
Gilead Sciences
Gilead Sciences
Not Provided
Study Director: Steve Lamola, MD Gilead Sciences
Gilead Sciences
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP