Table 3.

Summary of Reported Characteristics that May Modify the Response to Daily Treatment with an Inhaled Corticosteroid: TREXA, PEAK, CLIC, and PACT Trials

	TREXA	PEAK	CLIC	PACT
Population	6-18 years	2-3 years	6-17 years	6-14 years
Sample Size	288	285	126	191
Severity	mild	positive API	mild-to-moderate	mild-to-moderate
Duration	1 year	2 years	16 weeks	1 year
ICS	beclomethasone (40 μg bid)	fluticasone (88 μg bid)	fluticasone (100 μg bid)	fluticasone (100 μg bid)
Comparison	placebo	placebo	montelukast (5-10 mg qd)	montelukast (5 mg qd)
Risk Dimension	Time to First Exacerbation	Oral Corticosteroids	% Δ FEV1	Time to First Exacerbation
	Ethnicity3	Gender	Age	Parental Asthma History
	IgE Level3	Prior Healthcare Use	Asthma Control Days	PC20 <2mg/mL Prior ICS Use
	Prior OCS use3	Race	Body Mass Index
	Skin Test2	Skin Test	Eosinophil Cationic Protein
			FEV1 / FVC
		ED and Urgent Care Visits
		Prior Healthcare Use
		Race
		Skin Test
Control Dimension	Asthma Control Days	Episode Free Days	Asthma Control Days	Asthma Control Days
	Gender2	Gender	FENO	FENO >25 ppb Parental
	IgE Level2,3	Prior Healthcare Use		Asthma History
	Run-In Control1,2	Race
	Skin Test2

API, asthma predictive index; ED, emergency department; FENO, fractional exhaled nitric oxide; FEV₁ forced expiratory volume in 1 second; FVC, forced vital capacity; PC₂₀, methacholine concentration associated with 20% decline in FEV₁; ICS, inhaled corticosteroid; IgE, immunoglobulin E.

¹Symptom-driven ICS treatment (rescue)

²Daily ICS treatment (daily)

³Both symptom-driving and daily ICS treatment (combined).

CLIC, Characterizing the Response to a Leukotriene Receptor Antagonist and an Inhaled Corticosteroid trial; PACT, Pediatric Asthma Controller trial; PEAK, Prevention of Early Asthma in Kids trial; TREXA, Treating Children to Prevent Exacerbations trial.