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Validation of the AQLQ12+ among adolescents and adults with persistent asthma

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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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Correspondence to Kathleen W. Wyrwich.

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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

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