Variability of symptoms in mild persistent asthma: baseline data from the MIAMI study.
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, beta-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).


CONCLUSIONS
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.
Zeiger
Robert S
RS
Department of Allergy-Immunology, Kaiser Permanente Medical Center, 7060 Clairemont Mesa Boulevard, San Diego, CA 92111, USA. robert.s.zeiger@kp.org
Baker
James W
JW
Kaplan
Michael S
MS
Pearlman
David S
DS
Schatz
Michael
M
Bird
Steven
S
Hustad
Carolyn
C
Edelman
Jonathan
J
D000085:Acetates / Q000627:therapeutic use; D000284:Administration, Oral; D000293:Adolescent; D000305:Adrenal Cortex Hormones / Q000008:administration & dosage; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000420:Albuterol / Q000627:therapeutic use; D018927:Anti-Asthmatic Agents / Q000627:therapeutic use; D001249:Asthma / Q000188:drug therapy / Q000503:physiopathology*; D001993:Bronchodilator Agents / Q000627:therapeutic use; D015331:Cohort Studies; D003521:Cyclopropanes; D004311:Double-Blind Method; D015444:Exercise / Q000502:physiology; D005260:Female; D005541:Forced Expiratory Volume / Q000502:physiology; D006801:Humans; D020024:Leukotriene Antagonists / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D010342:Patient Acceptance of Health Care; D011804:Quinolines / Q000627:therapeutic use; D012720:Severity of Illness Index; D013440:Sulfides
D000085:Acetates; D000305:Adrenal Cortex Hormones; D018927:Anti-Asthmatic Agents; D001993:Bronchodilator Agents; D003521:Cyclopropanes; D020024:Leukotriene Antagonists; D011804:Quinolines; D013440:Sulfides; C093875:montelukast; D000420:Albuterol