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

Gilead Sciences89 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Bronchiectasis

Interventions

AZLIDRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (24)

Unnamed facility

Birmingham, Alabama, United States

Unnamed facility

Peoria, Arizona, United States

Outcomes

Primary Outcomes

Reliability of the Respiratory Domain of the Quality of Life Questionnaire-Bronchiectasis (QOL-B)

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.

Time frame: Day -14 to Day 0

Convergent Validity of the Respiratory Domain of the QOL-B

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.

Time frame: Day -14

Secondary Outcomes

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)

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.

Data from ClinicalTrials.gov

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