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Individualized Therapy For Asthma in Toddlers (INFANT)

This study has been completed.
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
dave mauger, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier:
NCT01606306
First received: May 23, 2012
Last updated: January 27, 2017
Last verified: January 2017
  Purpose

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.

Condition Intervention Phase
Asthma Wheezing Drug: daily fluticasone propionate Drug: Montelukast Drug: as-needed fluticasone propionate Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Individualized Therapy For Asthma in Toddlers

Resource links provided by NLM:


Further study details as provided by dave mauger, Milton S. Hershey Medical Center:

Primary Outcome Measures:
  • 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. [ Time Frame: The last 14 weeks of each 16-week treatment period ]
    The primary outcome was differential response to the three therapies on the basis of fixed threshold criteria for the following asthma control measures, which encompassed domains of risk and impairment: the time from the start of the treatment period to an asthma exacerbation treated with systemic corticosteroids, and the annualized number of asthma control days (ACDs) from within that period. ACDs were defined as full calendar days without symptoms, rescue medication use, or unscheduled healthcare visits. Children were defined as differential responders if, first, the time to an asthma exacerbation was at least four weeks longer, or second, if the number of annualized ACDs was at least 31 days more for one treatment than another, in that order. If neither threshold was met, the participant was considered a non differential responder. Differential response was determined in children completing at least two treatment periods and at least 50% of the daily diary entries for each period.


Enrollment: 300
Study Start Date: February 2013
Study Completion Date: April 2015
Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Crossover sequence 1
daily fluticasone propionate, followed by daily montelukast, followed by as needed fluticasone propionate
Drug: daily fluticasone propionate
Flovent® HFA, 44 mcg per inhalation, 2 inhalations twice daily
Drug: Montelukast
Singulair®, 4 mg granules or chewable tablets by mouth once daily in the evening
Drug: as-needed fluticasone propionate
Flovent® HFA, 44 mcg per inhalation, 2 inhalations, as needed for asthma symptoms
Experimental: Crossover sequence 2
daily fluticasone propionate, followed by as needed fluticasone propionate, followed by daily montelukast
Drug: daily fluticasone propionate
Flovent® HFA, 44 mcg per inhalation, 2 inhalations twice daily
Drug: Montelukast
Singulair®, 4 mg granules or chewable tablets by mouth once daily in the evening
Drug: as-needed fluticasone propionate
Flovent® HFA, 44 mcg per inhalation, 2 inhalations, as needed for asthma symptoms
Experimental: Crossover sequence 3
daily montelukast, followed by as needed fluticasone propionate, followed by daily fluticasone propionate
Drug: daily fluticasone propionate
Flovent® HFA, 44 mcg per inhalation, 2 inhalations twice daily
Drug: Montelukast
Singulair®, 4 mg granules or chewable tablets by mouth once daily in the evening
Drug: as-needed fluticasone propionate
Flovent® HFA, 44 mcg per inhalation, 2 inhalations, as needed for asthma symptoms
Experimental: Crossover sequence 4
daily montelukast, followed by daily fluticasone propionate, followed by as needed fluticasone propionate
Drug: daily fluticasone propionate
Flovent® HFA, 44 mcg per inhalation, 2 inhalations twice daily
Drug: Montelukast
Singulair®, 4 mg granules or chewable tablets by mouth once daily in the evening
Drug: as-needed fluticasone propionate
Flovent® HFA, 44 mcg per inhalation, 2 inhalations, as needed for asthma symptoms
Experimental: Crossover sequence 5
as needed fluticasone propionate, followed by daily fluticasone propionate, followed by daily montelukast
Drug: daily fluticasone propionate
Flovent® HFA, 44 mcg per inhalation, 2 inhalations twice daily
Drug: Montelukast
Singulair®, 4 mg granules or chewable tablets by mouth once daily in the evening
Drug: as-needed fluticasone propionate
Flovent® HFA, 44 mcg per inhalation, 2 inhalations, as needed for asthma symptoms
Experimental: Crossover sequence 6
as needed fluticasone propionate, followed by daily montelukast, followed by daily fluticasone propionate
Drug: daily fluticasone propionate
Flovent® HFA, 44 mcg per inhalation, 2 inhalations twice daily
Drug: Montelukast
Singulair®, 4 mg granules or chewable tablets by mouth once daily in the evening
Drug: as-needed fluticasone propionate
Flovent® HFA, 44 mcg per inhalation, 2 inhalations, as needed for asthma symptoms

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

Ages Eligible for Study:   12 Months to 59 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01606306

Locations
United States, Arizona
University of Arizona College of Medicine
Tucson, Arizona, United States, 85724
United States, California
Children's Hospital & Research Center Oakland
Oakland, California, United States, 94609
UCSF Benioff Children's Hospital
San Francisco, California, United States, 94143
United States, Colorado
National Jewish Health
Denver, Colorado, United States, 80206
United States, Georgia
Emory University
Atlanta, Georgia, United States, 30322
United States, Illinois
Rush University Medical Center/Stroger Hospital
Chicago, Illinois, United States, 60612
Children's Memorial Hospital
Chicago, Illinois, United States, 60614
United States, Massachusetts
Children's Hospital, Boston
Boston, Massachusetts, United States, 02115
United States, Missouri
St. Louis Children's Hospital
St. Louis, Missouri, United States, 63110
United States, Ohio
Rainbow Babies and Children's Hospital, Case Western Reserve University
Cleveland, Ohio, United States, 44106
United States, Pennsylvania
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, United States, 15224
United States, Virginia
University of Virginia Health System
Charlottesville, Virginia, United States, 22908
United States, Wisconsin
University of Wisconsin-Madison
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
Milton S. Hershey Medical Center
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Study Chair: William B Busse, MD University of Wisconsin, Madison
  More Information

Responsible Party: dave mauger, Principal Investigator, AsthmaNet Data Coordinating Center, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier: NCT01606306     History of Changes
Other Study ID Numbers: AsthmaNet 004
1U10HL098115 ( U.S. NIH Grant/Contract )
Study First Received: May 23, 2012
Results First Received: September 15, 2016
Last Updated: January 27, 2017

Keywords provided by dave mauger, Milton S. Hershey Medical Center:
Asthma
Wheezing
Fluticasone
Montelukast
Preschool-age

Additional relevant MeSH terms:
Asthma
Respiratory Sounds
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Fluticasone
Montelukast
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents
Anti-Allergic Agents
Leukotriene Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Cytochrome P-450 CYP1A2 Inducers
Cytochrome P-450 Enzyme Inducers
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 18, 2017