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Asthma | Individualized Therapy For Asthma in Toddlers

Asthma research study

What is the primary objective of this study?

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.

Who is eligible to participate?

Inclusion Criteria: - 12-59 months of age. - If the child is not currently taking long-term asthma controller therapy (meaning that the child has taken no inhaled corticosteroid or leukotriene receptor antagonist medication whatsoever over the past 6 months), then one of the following criteria must be met: - Daytime asthma symptoms more than two days per week (average over the past 4 weeks), - At least one nighttime awakening from asthma (over the past 4 weeks), - Two or more asthma exacerbations requiring systemic corticosteroids in the previous 6 months, - Four or more wheezing episodes in the previous 12 months. - If the child is currently taking long-term asthma controller therapy (meaning that the child has taken daily or intermittent/as-needed inhaled corticosteroid or leukotriene receptor antagonist over the past 6 months), then one of the following criteria must be met: - Taking inhaled corticosteroid or leukotriene receptor antagonist for more than 3 months (or more than 90 days) out of the previous 6 months (or 180 days), - Daytime asthma symptoms more than two days per week (average over the past 4 weeks), - More than one nighttime awakening from asthma (over the past 4 weeks), - Two or more asthma exacerbations requiring systemic corticosteroids in the previous 12 months, - Four or more wheezing episodes in the previous 12 months. - Up to date with immunizations, including varicella (unless the subject has already had clinical varicella). - Willingness to provide informed consent by the child's parent or guardian. Exclusion Criteria: - Allergic reaction to the study medications or any component of the study drugs, including (but not limited to) urticaria, rash, angioedema, or hypotension following delivery, - Chronic medical disorders that could interfere with drug metabolism/excretion (for instance chronic hepatic, biliary, or renal disease), - Chronic medical disorders that may increase the risk of drug-related injury, including (but not limited to): - Osteogenesis imperfecta (increased risk of bone demineralization/fracture with corticosteroid therapy), - Crohn's disease, ulcerative colitis, juvenile rheumatoid arthritis, clotting disorders, or Factor deficiency (increased risk of bleeding with corticosteroid therapy), - G6PD deficiency (increased risk of hemolytic anemia with acetaminophen use), - Phenylketonuria (potential for aspartame exposure with study interventions), - Seizure disorder treated with anticonvulsants (risk of acetaminophen toxicity with carbamazepine), or - History of clotting disorders or Factor deficiency (increased risk of bleeding with corticosteroids), - Co-morbid disorders associated with wheezing including (but not limited to) immune deficiency disorders, cystic fibrosis, aspiration, clinically-relevant gastroesophageal reflux, tracheomalacia, congenital airway anomalies (clefts, fistulas, slings, rings), bronchiectasis, bronchopulmonary dysplasia, and/or history of premature birth before 35 weeks gestation, - Significant developmental delay/failure to thrive, defined as 5th percentile for height and/or weight or crossing of two major percentile lines during the last year for age and sex, - History of a near-fatal asthma exacerbation requiring intubation or assisted ventilation, - No primary medical caregiver (e.g., a nurse practitioner, physician assistant, physician, or group medical practice such as a hospital-based clinic) whom the subject can contact for primary medical care, - Three or more hospitalizations in the previous 12 months for wheezing or respiratory illnesses, - Treatment with 5 or more courses of systemic corticosteroids (oral, intramuscular or intravenous) in the past 6 months, - Current use of higher than step 2 NAEPP asthma guideline therapy - If receiving allergy shots, change in the dose within the past 3 months.

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Asthma

Wheezing

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:daily fluticasone propionateFloventĀ® HFA, 44 mcg per inhalation, 2 inhalations twice daily

Drug:MontelukastSingulairĀ®, 4 mg granules or chewable tablets by mouth once daily in the evening

Drug:as-needed fluticasone propionateFloventĀ® HFA, 44 mcg per inhalation, 2 inhalations, as needed for asthma symptoms

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Crossover sequence 1daily fluticasone propionate, followed by daily montelukast, followed by as needed fluticasone propionate

Crossover sequence 2daily fluticasone propionate, followed by as needed fluticasone propionate, followed by daily montelukast

Crossover sequence 3daily montelukast, followed by as needed fluticasone propionate, followed by daily fluticasone propionate

Crossover sequence 4daily montelukast, followed by daily fluticasone propionate, followed by as needed fluticasone propionate

Crossover sequence 5as needed fluticasone propionate, followed by daily fluticasone propionate, followed by daily montelukast

Crossover sequence 6as needed fluticasone propionate, followed by daily montelukast, followed by daily fluticasone propionate

Study Status

Completed

Start Date: February 2013

Completed Date: April 2015

Phase: Phase 3

Type: Interventional

Design:

Primary Outcome: Differential Response to the Three Therapies Based on Fixed Threshold Criteria for the Following Asthma Control Measures: Use of Oral Prednisone for Acute Asthma Exacerbations and Asthma Control Days.

Secondary Outcome:

Study sponsors, principal investigator, and references

Principal Investigator: William B Busse, MD

Lead Sponsor: Milton S. Hershey Medical Center

Collaborator: National Heart, Lung, and Blood Institute (NHLBI)

More information:https://clinicaltrials.gov/show/NCT01606306

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