Abstract
Background
To date, there is limited psychometric evidence on the Asthma Quality of Life Questionnaire (AQLQ12 +) among populations that include adolescents and adults.
Objective
To provide evidence of the psychometric properties of the AQLQ12+ as a measure of asthma-specific quality of life (QOL) in patients with persistent asthma treated with a combination of inhaled glucocorticoid and long-acting beta2-agonist, as well as explore the predictors of at least a minimally important AQLQ12+ improvement.
Methods
The psychometric properties of the AQLQ12+ were assessed through post hoc analysis of two large (n = 740 and 778) Phase III, randomized, double-blinded, placebo-controlled efficacy studies of mometasone furoate/formoterol fumarate (MF/F) combination compared with monotherapy in subjects with persistent asthma previously treated with either low-dose or medium-dose inhaled glucocorticoids.
Results
With 15% and 8% participation from 12- to 17-year olds, blinded trial data demonstrated excellent reproducibility (ICC range: 0.76–0.85) and moderate-to-strong construct validity with other measures of asthma health at baseline and over time for the AQLQ12 +. A greater percentage of the MF/F treatment group (44%) achieved an important change at 26 weeks on the AQLQ12+ compared with formoterol fumarate (F, 23%) and placebo (18%) treatment groups in the low-dose study (P < 0.001) and the medium-dose study (50% (MF/F) versus 34% (F) and 23% (placebo); P < 0.001). Pre-randomization nighttime awakenings and rescue medications use were significant predictors of AQLQ12+ improvement.
Conclusions
These findings provide strong support for the measurement properties of the AQLQ12+ among patients with persistent asthma and confidence in the AQLQ12+ improvements demonstrated by the MF/F treatment group.
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Abbreviations
- ACQ:
-
Asthma Control Questionnaire
- AQLQ12+:
-
Asthma quality of life questionnaire with standardized activities (12 and older)
- AQLQ(S):
-
Asthma quality of life questionnaire-standardized version
- BID:
-
Twice a day
- CI:
-
Confidence interval
- COPD:
-
Chronic obstructive pulmonary disease
- F:
-
Formoterol fumarate
- FEV1 :
-
Forced expiratory volume in one second
- HIV:
-
Human immunodeficiency virus
- ICC:
-
Intraclass correlation coefficient
- MDI:
-
Metered dose inhaler
- MID:
-
Minimal important difference
- MF:
-
Mometasone furoate
- MF/F:
-
Mometasone furoate/formoterol fumarate
- PEF:
-
Peak expiratory flow
- QOL:
-
Quality of life
- SAS:
-
Statistical analysis software
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Acknowledgments
Funding for this manuscript was provided by Schering-Plough Corporation, now a division of Merck and Co.
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Wyrwich, K.W., Ireland, A.M., Navaratnam, P. et al. Validation of the AQLQ12+ among adolescents and adults with persistent asthma. Qual Life Res 20, 903–912 (2011). https://doi.org/10.1007/s11136-010-9821-3
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DOI: https://doi.org/10.1007/s11136-010-9821-3