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Individualized Therapy For Asthma in Toddlers | Clinical Trials | Clareo Health

COMPLETEDPHASE3

Individualized Therapy For Asthma in Toddlers

NCT01606306•Milton S. Hershey Medical Center

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.

Eligibility

Age

1 - 4 years

Sex

ALL

Healthy Volunteers

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),
+4 more criteria

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,
+7 more criteria

Locations (13)

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

Key Dates

Start Date

February 1, 2013

Primary Completion Date

April 1, 2015

Completion Date

April 1, 2015

Last Updated

March 16, 2017

Enrollment

300

ACTUAL participants

Conditions

AsthmaWheezing

Interventions

daily fluticasone propionate

DRUG

Montelukast

DRUG

as-needed fluticasone propionate

DRUG

NHALES (Natural History of Asthma With Longitudinal Environmental Sampling)

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 16, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Individualized Therapy For Asthma in Toddlers

Inclusion Criteria

Exclusion Criteria

NHALES (Natural History of Asthma With Longitudinal Environmental Sampling)

A Study to Evaluate Brenipatide Compared With Placebo in Adult Participants With Uncontrolled Moderate to Severe Asthma

Blood Eosinophil Guided Versus Usual Care In The Management Of Mild To Moderate Asthma at Primary Care (BEAM)

Relationship of Airway Microbiota, Endotype and Phenotype in Adult Asthma

To Assess the Management of Patients on Global Initiative of Asthma (GINA) Step 4 and 5 Treatment in Hong Kong

A Study to Investigate Efficacy and Safety of PT027 Compared With PT007 in Symptomatic Chinese Adults With Asthma