Add-on montelukast in inadequately controlled asthma patients in a 6-month open-label study: The MONtelukast In Chronic Asthma (MONICA) study

Summary Bronchial asthma often remains uncontrolled despite treatment with inhaled corticosteroids (ICS), long-acting β2 -agonists (LABA) or both, necessitating additional treatment. Patients ≥18 years ( n = 1681) with mild-to-moderate asthma received oral montelukast 10 mg added to ICS or ICS + LAB...

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Veröffentlicht in:Respiratory medicine 2010-05, Vol.104 (5), p.644-651
Hauptverfasser: Virchow, J. Christian, Mehta, Anish, Ljungblad, Li, Mitfessel, Harald
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container_title Respiratory medicine
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creator Virchow, J. Christian
Mehta, Anish
Ljungblad, Li
Mitfessel, Harald
description Summary Bronchial asthma often remains uncontrolled despite treatment with inhaled corticosteroids (ICS), long-acting β2 -agonists (LABA) or both, necessitating additional treatment. Patients ≥18 years ( n = 1681) with mild-to-moderate asthma received oral montelukast 10 mg added to ICS or ICS + LABAs, and were followed for 6 months in a prospective, open-label observational study. The primary endpoint was change in Asthma Control Test (ACT) score. Secondary endpoints included mini-Asthma Quality-of-Life Questionnaire (mini-AQLQ) and FEV1 /PEF. Mean ACT scores improved from 14.6 ± 4.6 (baseline) to 19.4 ± 4.4 (month 6; p < 0.0001). Using ACT score categories, the percentage of patients with uncontrolled (57.5%) or poorly controlled (25.0%) asthma at baseline decreased at month 6 (17.6 and 21.7%, respectively); the percentage of patients with well controlled (13.9%) or completely controlled (1.2%) asthma at baseline increased at month 6 (47.5 and 11.4%, respectively). The mini-AQLQ score (mean ± SD) improved from 4.0 ± 1.1 to 5.3 ± 1.1 ( p < 0.0001); FEV1 increased from 2.46 ± 0.89 to 2.60 ± 0.92 L ( p < 0.0001). Treatment with montelukast was generally well tolerated. In patients insufficiently controlled with ICS or ICS + LABAs, daily add-on montelukast improved both asthma control and asthma-related quality of life. Clinicaltrials.gov registry number NCT00802789.
doi_str_mv 10.1016/j.rmed.2009.11.022
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Using ACT score categories, the percentage of patients with uncontrolled (57.5%) or poorly controlled (25.0%) asthma at baseline decreased at month 6 (17.6 and 21.7%, respectively); the percentage of patients with well controlled (13.9%) or completely controlled (1.2%) asthma at baseline increased at month 6 (47.5 and 11.4%, respectively). The mini-AQLQ score (mean ± SD) improved from 4.0 ± 1.1 to 5.3 ± 1.1 ( p &lt; 0.0001); FEV1 increased from 2.46 ± 0.89 to 2.60 ± 0.92 L ( p &lt; 0.0001). Treatment with montelukast was generally well tolerated. In patients insufficiently controlled with ICS or ICS + LABAs, daily add-on montelukast improved both asthma control and asthma-related quality of life. 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Christian</creatorcontrib><creatorcontrib>Mehta, Anish</creatorcontrib><creatorcontrib>Ljungblad, Li</creatorcontrib><creatorcontrib>Mitfessel, Harald</creatorcontrib><creatorcontrib>the MONICA study group</creatorcontrib><creatorcontrib>MONICA study group</creatorcontrib><title>Add-on montelukast in inadequately controlled asthma patients in a 6-month open-label study: The MONtelukast In Chronic Asthma (MONICA) study</title><title>Respiratory medicine</title><addtitle>Respir Med</addtitle><description>Summary Bronchial asthma often remains uncontrolled despite treatment with inhaled corticosteroids (ICS), long-acting β2 -agonists (LABA) or both, necessitating additional treatment. Patients ≥18 years ( n = 1681) with mild-to-moderate asthma received oral montelukast 10 mg added to ICS or ICS + LABAs, and were followed for 6 months in a prospective, open-label observational study. The primary endpoint was change in Asthma Control Test (ACT) score. 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Christian</au><au>Mehta, Anish</au><au>Ljungblad, Li</au><au>Mitfessel, Harald</au><aucorp>the MONICA study group</aucorp><aucorp>MONICA study group</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Add-on montelukast in inadequately controlled asthma patients in a 6-month open-label study: The MONtelukast In Chronic Asthma (MONICA) study</atitle><jtitle>Respiratory medicine</jtitle><addtitle>Respir Med</addtitle><date>2010-05-01</date><risdate>2010</risdate><volume>104</volume><issue>5</issue><spage>644</spage><epage>651</epage><pages>644-651</pages><issn>0954-6111</issn><eissn>1532-3064</eissn><abstract>Summary Bronchial asthma often remains uncontrolled despite treatment with inhaled corticosteroids (ICS), long-acting β2 -agonists (LABA) or both, necessitating additional treatment. Patients ≥18 years ( n = 1681) with mild-to-moderate asthma received oral montelukast 10 mg added to ICS or ICS + LABAs, and were followed for 6 months in a prospective, open-label observational study. The primary endpoint was change in Asthma Control Test (ACT) score. Secondary endpoints included mini-Asthma Quality-of-Life Questionnaire (mini-AQLQ) and FEV1 /PEF. Mean ACT scores improved from 14.6 ± 4.6 (baseline) to 19.4 ± 4.4 (month 6; p &lt; 0.0001). Using ACT score categories, the percentage of patients with uncontrolled (57.5%) or poorly controlled (25.0%) asthma at baseline decreased at month 6 (17.6 and 21.7%, respectively); the percentage of patients with well controlled (13.9%) or completely controlled (1.2%) asthma at baseline increased at month 6 (47.5 and 11.4%, respectively). The mini-AQLQ score (mean ± SD) improved from 4.0 ± 1.1 to 5.3 ± 1.1 ( p &lt; 0.0001); FEV1 increased from 2.46 ± 0.89 to 2.60 ± 0.92 L ( p &lt; 0.0001). Treatment with montelukast was generally well tolerated. In patients insufficiently controlled with ICS or ICS + LABAs, daily add-on montelukast improved both asthma control and asthma-related quality of life. Clinicaltrials.gov registry number NCT00802789.</abstract><cop>Kidlington</cop><pub>Elsevier Ltd</pub><pmid>20031382</pmid><doi>10.1016/j.rmed.2009.11.022</doi><tpages>8</tpages><oa>free_for_read</oa></addata></record>
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subjects Acetates - administration & dosage
Add-on therapy
Adrenergic beta-Agonists - administration & dosage
Adult
Anti-Asthmatic Agents - administration & dosage
Asthma
Asthma - drug therapy
Asthma - psychology
Asthma therapy
Biological and medical sciences
Chronic obstructive pulmonary disease, asthma
Clinical medicine
Dose-Response Relationship, Drug
Drug therapy
Drug Therapy, Combination
Female
Humans
Leukotriene receptor antagonist
Male
Medical sciences
Middle Aged
Montelukast
Mortality
Pneumology
Prospective Studies
Pulmonary/Respiratory
Quality of Life - psychology
Quinolines - administration & dosage
Standard deviation
Studies
Surveys and Questionnaires
Treatment Outcome
Young Adult
title Add-on montelukast in inadequately controlled asthma patients in a 6-month open-label study: The MONtelukast In Chronic Asthma (MONICA) study
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