Conditions: Asthma Wheezing
Keywords: Asthma Wheezing Fluticasone Montelukast Preschool-age
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 300
Healthy volunteers: no

Brief summary:
The INFANT study will test whether, in preschool children 12-59 months of age with persistent asthma, the following Step 2 asthma therapies will provide similar degrees of asthma control:

1. Daily inhaled corticosteroid (ICS) treatment,
2. Daily leukotriene receptor antagonist (LTRA) treatment, and
3. As-needed ICS plus short-acting beta agonist (as-needed ICS/SABA) rescue treatment.

Detailed description:
INFANT is a double-blind, randomized clinical trial in which all participants will receive each of the three therapies for 16 weeks by means of a cross-over study design. INFANT aims to determine whether individual children respond better to one treatment than another and, if so, whether those children can be identified by phenotypic characteristics or selected biomarkers. In this regard the INFANT study is expected to address critical gaps in current asthma management guidelines. Ultimately, the findings from this study are expected to help clarify treatment modalities for this population of young preschool children who are extremely difficult to treat.

Arms:
arm 1: daily fluticasone propionate, followed by daily montelukast, followed by as needed fluticasone propionate arm 2: daily fluticasone propionate, followed by as needed fluticasone propionate, followed by daily montelukast arm 3: daily montelukast, followed by as needed fluticasone propionate, followed by daily fluticasone propionate arm 4: daily montelukast, followed by daily fluticasone propionate, followed by as needed fluticasone propionate arm 5: as needed fluticasone propionate, followed by daily fluticasone propionate, followed by daily montelukast arm 6: as needed fluticasone propionate, followed by daily montelukast, followed by daily fluticasone propionate

Interventions: intervention 1: daily fluticasone propionate intervention 2: Montelukast intervention 3: as-needed fluticasone propionate
Intervention descriptions: intervention 1: Flovent® HFA, 44 mcg per inhalation, 2 inhalations twice daily intervention 2: Singulair®, 4 mg granules or chewable tablets by mouth once daily in the evening intervention 3: Flovent® HFA, 44 mcg per inhalation, 2 inhalations, as needed for asthma symptoms

Protocol document: