Elsevier

Respiratory Medicine

Volume 98, Issue 9, September 2004, Pages 898-905
Respiratory Medicine

Variability of symptoms in mild persistent asthma: baseline data from the MIAMI study

https://doi.org/10.1016/j.rmed.2004.02.016Get rights and content
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Abstract

Objective: To describe the variability of the asthma phenotype in patients with mild persistent asthma enrolled in the Mild Asthma Montelukast versus Inhaled Corticosteroid (MIAMI) study.

Methods: The variability of asthma rescue-free days, asthma symptoms, albuterol use, medical resource use, and exercise limitations among patients with documented mild persistent asthma was compared between the month before study enrollment and the last 2 weeks of the run-in period.

Results: Patients eligible for randomization (n=400), aged 15–85 years, exhibited symptoms (mean±sd) 3.6±1.3 days/week, β-agonist use 3.5±1.3 days/week, and normal FEV1 (94.0±9.9% predicted) during the last 2 weeks of the run-in period. In the year before enrollment, medical intervention for asthma flares was common: 38.5% made office visits, 15.8% had oral corticosteroids, and 8.3% required emergency room or hospitalized care. In the month before enrollment, 11.8% experienced daily symptoms, and 28.3% had limitations of normal activity. Patients with daily symptoms in the month before study enrollment, compared with those having less-than-daily symptoms, experienced fewer rescue-free days (P=0.024) and had more days per week with symptoms (P=0.008) and requiring albuterol (P=0.048) during the run-in; FEV1 was similar for both groups (93.1% vs. 94.2% predicted, respectively).

Conclusion: Patients with mild persistent asthma reported a substantial disease burden in the year before enrollment. The asthma burden experienced by these patients both before and during the run-in period was of sufficient severity to support the recommendation that mild persistent asthma should be managed with daily controller therapy.

Keywords

Mild persistent asthma
Leukotriene receptor antagonist
Montelukast
Inhaled corticosteroids
Fluticasone
Airway inflammation
Severity variability
Clinical trial

Abbreviations

FEV1
Forced expiratory volume in 1 s
GINA
Global initiative for asthma
MIAMI
Mild asthma montelukast versus inhaled corticosteroid study
NAEPP
National asthma education prevention program
PC20 FEV1
Provocative concentration of methacholine leading to a 20% or greater decrease in FEV1
PEF
Peak expiratory flow rate
RFD
Rescue-free day

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1

A list of the members of the MIAMI Study Research Group appears in Acknowledgements.