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191 Quality of Life Improvements in Persistent Asthma Subjects Receiving Combined Mometasone Furoate and Formoterol

BACKGROUND: A major goal of asthma treatment is to improve patients' health-related quality of life (QoL). Mometasone furoate/formoterol (MF/F) combination therapy was recently approved for the treatment of persistent asthma. The objective of this analysis was to examine the effect of MF/F on h...

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Autores principales: Murphy, Kevin, Meltzer, Eli, Nathan, Robert, Nolte, Hendrik
Formato: Online Artículo Texto
Lenguaje:English
Publicado: World Allergy Organization Journal 2012
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3512923/
http://dx.doi.org/10.1097/01.WOX.0000411948.51471.cd
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author Murphy, Kevin
Meltzer, Eli
Nathan, Robert
Nolte, Hendrik
author_facet Murphy, Kevin
Meltzer, Eli
Nathan, Robert
Nolte, Hendrik
author_sort Murphy, Kevin
collection PubMed
description BACKGROUND: A major goal of asthma treatment is to improve patients' health-related quality of life (QoL). Mometasone furoate/formoterol (MF/F) combination therapy was recently approved for the treatment of persistent asthma. The objective of this analysis was to examine the effect of MF/F on health-related QoL at the approved doses. METHODS: Data from 2 phase III studies investigating the effects of MF/F 200/10 μg (study P04334) and MF/F 400/10 μg (study P04431) were included. All subjects were ≥12 yeara and not well controlled on medium dose (P04334) or high-dose (P04431) inhaled corticosteroid (ICS). After 2 to 3 weeks of run-in on twice-daily (BID) MF 200 μg (P04334) or 400 μg (P04431), subjects were randomized to 26 weeks of BID MF/F 200/10 μg, MF 200 μg, F 10 μg, or placebo (PBO) in P04334; or 12 weeks of BID MF/F 200/10 μg, MF/F 400/10 μg, or MF 400 μg in P04431. The Asthma Quality of Life Questionnaire with Standardized Activities (AQLQ [S]), consisting of 4 domains (Symptoms, Activity Limitation, Emotional Function, and Environmental Stimuli), was used to assess QoL. AQLQ(S) score changes from baseline were assessed; a difference ≥0.5 was considered clinically meaningful. Study protocols were approved by IRBs; written informed consent was provided by all subjects or a parent/guardian. RESULTS: In P04334 (n = 781), subjects receiving MF/F 200/10μg experienced significant improvements in total score (13.1%) and the 4 domain scores of the AQLQ (S) at endpoint vs those receiving PBO (P ≤ 0.005) or F 10 μg (P ≤ 0.024). Clinically meaningful improvements in total AQLQ (S) from baseline to week 26 were observed in patients receiving MF/F 200/10 μg (0.61). In P04431 (n = 728), subjects receiving MF/F 200/10 μg experienced significant improvements in total score (12.8%) and the Symptoms and Activity Limitation domain scores of the AQLQ (S) at endpoint vs those who received MF 400 μg (P ≤ 0.017). Clinically meaningful improvements in total AQLQ (S) from baseline to week 12 occurred in patients receiving MF/F 200/10 μg (0.61), MF/F 400/10 μg (0.51), or MF 400 μg (0.5). CONCLUSIONS: Patients with persistent asthma receiving MF/F had statistically significant, clinically meaningful improvements in QoL in 2 phase III studies. These data suggest that MF/F combination therapy improves the health-related QoL of patients with persistent asthma who are inadequately controlled on medium- or high-dose ICS.
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spelling pubmed-35129232012-12-21 191 Quality of Life Improvements in Persistent Asthma Subjects Receiving Combined Mometasone Furoate and Formoterol Murphy, Kevin Meltzer, Eli Nathan, Robert Nolte, Hendrik World Allergy Organ J Abstracts of the XXII World Allergy Congress BACKGROUND: A major goal of asthma treatment is to improve patients' health-related quality of life (QoL). Mometasone furoate/formoterol (MF/F) combination therapy was recently approved for the treatment of persistent asthma. The objective of this analysis was to examine the effect of MF/F on health-related QoL at the approved doses. METHODS: Data from 2 phase III studies investigating the effects of MF/F 200/10 μg (study P04334) and MF/F 400/10 μg (study P04431) were included. All subjects were ≥12 yeara and not well controlled on medium dose (P04334) or high-dose (P04431) inhaled corticosteroid (ICS). After 2 to 3 weeks of run-in on twice-daily (BID) MF 200 μg (P04334) or 400 μg (P04431), subjects were randomized to 26 weeks of BID MF/F 200/10 μg, MF 200 μg, F 10 μg, or placebo (PBO) in P04334; or 12 weeks of BID MF/F 200/10 μg, MF/F 400/10 μg, or MF 400 μg in P04431. The Asthma Quality of Life Questionnaire with Standardized Activities (AQLQ [S]), consisting of 4 domains (Symptoms, Activity Limitation, Emotional Function, and Environmental Stimuli), was used to assess QoL. AQLQ(S) score changes from baseline were assessed; a difference ≥0.5 was considered clinically meaningful. Study protocols were approved by IRBs; written informed consent was provided by all subjects or a parent/guardian. RESULTS: In P04334 (n = 781), subjects receiving MF/F 200/10μg experienced significant improvements in total score (13.1%) and the 4 domain scores of the AQLQ (S) at endpoint vs those receiving PBO (P ≤ 0.005) or F 10 μg (P ≤ 0.024). Clinically meaningful improvements in total AQLQ (S) from baseline to week 26 were observed in patients receiving MF/F 200/10 μg (0.61). In P04431 (n = 728), subjects receiving MF/F 200/10 μg experienced significant improvements in total score (12.8%) and the Symptoms and Activity Limitation domain scores of the AQLQ (S) at endpoint vs those who received MF 400 μg (P ≤ 0.017). Clinically meaningful improvements in total AQLQ (S) from baseline to week 12 occurred in patients receiving MF/F 200/10 μg (0.61), MF/F 400/10 μg (0.51), or MF 400 μg (0.5). CONCLUSIONS: Patients with persistent asthma receiving MF/F had statistically significant, clinically meaningful improvements in QoL in 2 phase III studies. These data suggest that MF/F combination therapy improves the health-related QoL of patients with persistent asthma who are inadequately controlled on medium- or high-dose ICS. World Allergy Organization Journal 2012-02-17 /pmc/articles/PMC3512923/ http://dx.doi.org/10.1097/01.WOX.0000411948.51471.cd Text en Copyright © 2012 by World Allergy Organization
spellingShingle Abstracts of the XXII World Allergy Congress
Murphy, Kevin
Meltzer, Eli
Nathan, Robert
Nolte, Hendrik
191 Quality of Life Improvements in Persistent Asthma Subjects Receiving Combined Mometasone Furoate and Formoterol
title 191 Quality of Life Improvements in Persistent Asthma Subjects Receiving Combined Mometasone Furoate and Formoterol
title_full 191 Quality of Life Improvements in Persistent Asthma Subjects Receiving Combined Mometasone Furoate and Formoterol
title_fullStr 191 Quality of Life Improvements in Persistent Asthma Subjects Receiving Combined Mometasone Furoate and Formoterol
title_full_unstemmed 191 Quality of Life Improvements in Persistent Asthma Subjects Receiving Combined Mometasone Furoate and Formoterol
title_short 191 Quality of Life Improvements in Persistent Asthma Subjects Receiving Combined Mometasone Furoate and Formoterol
title_sort 191 quality of life improvements in persistent asthma subjects receiving combined mometasone furoate and formoterol
topic Abstracts of the XXII World Allergy Congress
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3512923/
http://dx.doi.org/10.1097/01.WOX.0000411948.51471.cd
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