Add-on montelukast in inadequately controlled asthma patients in a 6-month open-label study: the MONtelukast In Chronic Asthma (MONICA) study.
Bronchial asthma often remains uncontrolled despite treatment with inhaled corticosteroids (ICS), long-acting beta(2)-agonists (LABA) or both, necessitating additional treatment. Patients >or=18 years (n=1681) with mild-to-moderate asthma received oral montelukast 10mg 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 FEV(1)/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); FEV(1) increased from 2.46+/-0.89 to 2.60+/-0.92L (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.
Virchow
J Christian
JC
Department of Pneumology, University of Rostock, Rostock, Germany. j.c.virchow@med.uni-rostock.de
Mehta
Anish
A
Ljungblad
Li
L
Mitfessel
Harald
H
D000085:Acetates / Q000008:administration & dosage*; D000318:Adrenergic beta-Agonists / Q000008:administration & dosage*; D000328:Adult; D018927:Anti-Asthmatic Agents / Q000008:administration & dosage*; D001249:Asthma / Q000188:drug therapy* / Q000523:psychology; D003521:Cyclopropanes; D004305:Dose-Response Relationship, Drug; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D011788:Quality of Life / Q000523:psychology; D011804:Quinolines / Q000008:administration & dosage*; D013440:Sulfides; D011795:Surveys and Questionnaires; D016896:Treatment Outcome; D055815:Young Adult
D000085:Acetates; D000318:Adrenergic beta-Agonists; D018927:Anti-Asthmatic Agents; D003521:Cyclopropanes; D011804:Quinolines; D013440:Sulfides; C093875:montelukast