Individualized Therapy For Asthma in Toddlers

Completed · Phase 3

Conditions studied: Asthma, Wheezing

In brief

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.

Key facts

Study ID

NCT01606306

Run by

Milton S. Hershey Medical Center

People needed

300

Starts

2013-02-01

Expected to finish

2015-04-01

Last updated by the study team

2017-03-16

Who can join

Age: 1 and older, up to 5. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University of Arizona College of Medicine — Tucson, Arizona, United States
• Children's Hospital & Research Center Oakland — Oakland, California, United States
• UCSF Benioff Children's Hospital — San Francisco, California, United States
• National Jewish Health — Denver, Colorado, United States
• Emory University — Atlanta, Georgia, United States
• Rush University Medical Center/Stroger Hospital — Chicago, Illinois, United States
• Children's Memorial Hospital — Chicago, Illinois, United States
• Children's Hospital, Boston — Boston, Massachusetts, United States
• St. Louis Children's Hospital — St Louis, Missouri, United States
• Rainbow Babies and Children's Hospital, Case Western Reserve University — Cleveland, Ohio, United States
• Children's Hospital of Pittsburgh of UPMC — Pittsburgh, Pennsylvania, United States
• University of Virginia Health System — Charlottesville, Virginia, United States
• University of Wisconsin-Madison — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

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