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Subgroup Analysis of a Randomized Trial of the Effects of Positive Messaging on Patient-Reported Outcomes with Asthma - Effect of Obesity.

Publication ,  Journal Article
Mathews, AM; Riley, I; Henderson, R; Holbrook, JT; Lang, JE; Dixon, AE; Wise, RA; Que, LG
Published in: J Asthma Allergy
2022

OBJECTIVE: Asthma in obese patients represents a specific phenotype that is associated with increased symptoms, more frequent and severe exacerbations, reduced responsiveness to treatment, and decreased quality of life. Marketing and placebos have been shown to alter subjective responses to interventions in both asthma and obesity. We evaluated obesity as a potential treatment effect modifier of the effects enhanced drug messaging or placebos on subjective asthma outcomes. METHODS: We conducted a secondary analysis of a multicenter, randomized clinical trial that studied the effect of messaging and placebos on asthma outcomes. A total of 601 participants were randomized (1:1:1:1:1) to one of 5 groups: enhanced messaging with montelukast or placebo, neutral messaging with montelukast or placebo, or usual care and followed for 4 weeks after randomization. We compared baseline characteristics by obesity status for 600 participants with data on body weight. Obesity was evaluated as an effect modifier for enhanced messaging (versus neutral messaging) and on placebo effects (versus usual care) in 362 participants assigned to a placebo group or usual care for three asthma questionnaires: Asthma Control Questionnaire, Asthma Quality of Life Questionnaire and Asthma Symptoms Utility Index. RESULTS: Overall, 227 (37%) of participants were obese. Obese participants were older (mean age 41 vs 34), more likely female (82% vs 67%) and self-identified as Black (44% vs 25%) than non-obese participants. As previously published, enhanced messaging was associated with improvements in patient-reported asthma scores, but there was no evidence for a placebo effect. Obesity status did not influence the message effects nor did it modify responses to placebo. CONCLUSION: Obesity has been shown to be an important factor associated with asthma outcomes and an effect modifier of drug treatment effects. We conducted a post hoc, subgroup analysis of data from a multicenter randomized trial of enhanced messaging and placebo associated with drug treatment on asthma outcomes. Our findings suggest that observed differences in treatment effects between obese and non-obese patients sometimes seen in trials of asthma treatments are unlikely to be due to different "placebo" effects of treatment and may reflect differential physiologic effects of active agents.

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Published In

J Asthma Allergy

DOI

ISSN

1178-6965

Publication Date

2022

Volume

15

Start / End Page

1743 / 1751

Location

New Zealand

Related Subject Headings

  • 3204 Immunology
  • 1107 Immunology
 

Citation

APA
Chicago
ICMJE
MLA
NLM
Mathews, A. M., Riley, I., Henderson, R., Holbrook, J. T., Lang, J. E., Dixon, A. E., … Que, L. G. (2022). Subgroup Analysis of a Randomized Trial of the Effects of Positive Messaging on Patient-Reported Outcomes with Asthma - Effect of Obesity. J Asthma Allergy, 15, 1743–1751. https://doi.org/10.2147/JAA.S336945
Mathews, Anne M., Isaretta Riley, Robert Henderson, Janet T. Holbrook, Jason E. Lang, Anne E. Dixon, Robert A. Wise, and Loretta G. Que. “Subgroup Analysis of a Randomized Trial of the Effects of Positive Messaging on Patient-Reported Outcomes with Asthma - Effect of Obesity.J Asthma Allergy 15 (2022): 1743–51. https://doi.org/10.2147/JAA.S336945.
Mathews AM, Riley I, Henderson R, Holbrook JT, Lang JE, Dixon AE, et al. Subgroup Analysis of a Randomized Trial of the Effects of Positive Messaging on Patient-Reported Outcomes with Asthma - Effect of Obesity. J Asthma Allergy. 2022;15:1743–51.
Mathews, Anne M., et al. “Subgroup Analysis of a Randomized Trial of the Effects of Positive Messaging on Patient-Reported Outcomes with Asthma - Effect of Obesity.J Asthma Allergy, vol. 15, 2022, pp. 1743–51. Pubmed, doi:10.2147/JAA.S336945.
Mathews AM, Riley I, Henderson R, Holbrook JT, Lang JE, Dixon AE, Wise RA, Que LG. Subgroup Analysis of a Randomized Trial of the Effects of Positive Messaging on Patient-Reported Outcomes with Asthma - Effect of Obesity. J Asthma Allergy. 2022;15:1743–1751.

Published In

J Asthma Allergy

DOI

ISSN

1178-6965

Publication Date

2022

Volume

15

Start / End Page

1743 / 1751

Location

New Zealand

Related Subject Headings

  • 3204 Immunology
  • 1107 Immunology