Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Individualized Therapy For Asthma in Toddlers (INFANT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01606306
Recruitment Status : Completed
First Posted : May 25, 2012
Results First Posted : March 16, 2017
Last Update Posted : March 16, 2017
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
dave mauger, Milton S. Hershey Medical Center

Tracking Information
First Submitted Date  ICMJE May 23, 2012
First Posted Date  ICMJE May 25, 2012
Results First Submitted Date  ICMJE September 15, 2016
Results First Posted Date  ICMJE March 16, 2017
Last Update Posted Date March 16, 2017
Study Start Date  ICMJE February 2013
Actual Primary Completion Date April 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 27, 2017)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: May 24, 2012)
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 ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Individualized Therapy For Asthma in Toddlers
Official Title  ICMJE Individualized Therapy For Asthma in Toddlers
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Asthma
  • Wheezing
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: Crossover sequence 1
    daily fluticasone propionate, followed by daily montelukast, followed by as needed fluticasone propionate
    Interventions:
    • Drug: daily fluticasone propionate
    • Drug: Montelukast
    • Drug: as-needed fluticasone propionate
  • Experimental: Crossover sequence 2
    daily fluticasone propionate, followed by as needed fluticasone propionate, followed by daily montelukast
    Interventions:
    • Drug: daily fluticasone propionate
    • Drug: Montelukast
    • Drug: as-needed fluticasone propionate
  • Experimental: Crossover sequence 3
    daily montelukast, followed by as needed fluticasone propionate, followed by daily fluticasone propionate
    Interventions:
    • Drug: daily fluticasone propionate
    • Drug: Montelukast
    • Drug: as-needed fluticasone propionate
  • Experimental: Crossover sequence 4
    daily montelukast, followed by daily fluticasone propionate, followed by as needed fluticasone propionate
    Interventions:
    • Drug: daily fluticasone propionate
    • Drug: Montelukast
    • Drug: as-needed fluticasone propionate
  • Experimental: Crossover sequence 5
    as needed fluticasone propionate, followed by daily fluticasone propionate, followed by daily montelukast
    Interventions:
    • Drug: daily fluticasone propionate
    • Drug: Montelukast
    • Drug: as-needed fluticasone propionate
  • Experimental: Crossover sequence 6
    as needed fluticasone propionate, followed by daily montelukast, followed by daily fluticasone propionate
    Interventions:
    • Drug: daily fluticasone propionate
    • Drug: Montelukast
    • Drug: as-needed fluticasone propionate
Publications * Fitzpatrick AM, Jackson DJ, Mauger DT, Boehmer SJ, Phipatanakul W, Sheehan WJ, Moy JN, Paul IM, Bacharier LB, Cabana MD, Covar R, Holguin F, Lemanske RF Jr, Martinez FD, Pongracic JA, Beigelman A, Baxi SN, Benson M, Blake K, Chmiel JF, Daines CL, Daines MO, Gaffin JM, Gentile DA, Gower WA, Israel E, Kumar HV, Lang JE, Lazarus SC, Lima JJ, Ly N, Marbin J, Morgan W, Myers RE, Olin JT, Peters SP, Raissy HH, Robison RG, Ross K, Sorkness CA, Thyne SM, Szefler SJ; NIH/NHLBI AsthmaNet. Individualized therapy for persistent asthma in young children. J Allergy Clin Immunol. 2016 Dec;138(6):1608-1618.e12. doi: 10.1016/j.jaci.2016.09.028. Epub 2016 Oct 21.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 6, 2015)
300
Original Estimated Enrollment  ICMJE
 (submitted: May 24, 2012)
294
Actual Study Completion Date  ICMJE April 2015
Actual Primary Completion Date April 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Months to 59 Months   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01606306
Other Study ID Numbers  ICMJE AsthmaNet 004
1U10HL098115 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party dave mauger, Milton S. Hershey Medical Center
Study Sponsor  ICMJE Milton S. Hershey Medical Center
Collaborators  ICMJE National Heart, Lung, and Blood Institute (NHLBI)
Investigators  ICMJE
Study Chair: William B Busse, MD University of Wisconsin, Madison
PRS Account Milton S. Hershey Medical Center
Verification Date January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP