NCT01606306

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. 1.Daily inhaled corticosteroid (ICS) treatment,
  2. 2.Daily leukotriene receptor antagonist (LTRA) treatment, and
  3. 3.As-needed ICS plus short-acting beta agonist (as-needed ICS/SABA) rescue treatment.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P25-P50 for phase_3 asthma

Timeline
Completed

Started Feb 2013

Typical duration for phase_3 asthma

Geographic Reach
1 country

13 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 23, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 25, 2012

Completed
8 months until next milestone

Study Start

First participant enrolled

February 1, 2013

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
2 years until next milestone

Results Posted

Study results publicly available

March 16, 2017

Completed
Last Updated

March 16, 2017

Status Verified

January 1, 2017

Enrollment Period

2.2 years

First QC Date

May 23, 2012

Results QC Date

September 15, 2016

Last Update Submit

January 27, 2017

Conditions

AsthmaWheezing

Keywords

AsthmaWheezingFluticasoneMontelukastPreschool-age

Outcome Measures

Primary Outcomes (1)

  • 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.

    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.

    The last 14 weeks of each 16-week treatment period

Study Arms (6)

Crossover sequence 1

EXPERIMENTAL

daily fluticasone propionate, followed by daily montelukast, followed by as needed fluticasone propionate

Drug: daily fluticasone propionateDrug: MontelukastDrug: as-needed fluticasone propionate

Crossover sequence 2

EXPERIMENTAL

daily fluticasone propionate, followed by as needed fluticasone propionate, followed by daily montelukast

Drug: daily fluticasone propionateDrug: MontelukastDrug: as-needed fluticasone propionate

Crossover sequence 3

EXPERIMENTAL

daily montelukast, followed by as needed fluticasone propionate, followed by daily fluticasone propionate

Drug: daily fluticasone propionateDrug: MontelukastDrug: as-needed fluticasone propionate

Crossover sequence 4

EXPERIMENTAL

daily montelukast, followed by daily fluticasone propionate, followed by as needed fluticasone propionate

Drug: daily fluticasone propionateDrug: MontelukastDrug: as-needed fluticasone propionate

Crossover sequence 5

EXPERIMENTAL

as needed fluticasone propionate, followed by daily fluticasone propionate, followed by daily montelukast

Drug: daily fluticasone propionateDrug: MontelukastDrug: as-needed fluticasone propionate

Crossover sequence 6

EXPERIMENTAL

as needed fluticasone propionate, followed by daily montelukast, followed by daily fluticasone propionate

Drug: daily fluticasone propionateDrug: MontelukastDrug: as-needed fluticasone propionate

Interventions

daily fluticasone propionateDRUG

Flovent® HFA, 44 mcg per inhalation, 2 inhalations twice daily

Crossover sequence 1Crossover sequence 2Crossover sequence 3Crossover sequence 4Crossover sequence 5Crossover sequence 6
MontelukastDRUG

Singulair®, 4 mg granules or chewable tablets by mouth once daily in the evening

Crossover sequence 1Crossover sequence 2Crossover sequence 3Crossover sequence 4Crossover sequence 5Crossover sequence 6
as-needed fluticasone propionateDRUG

Flovent® HFA, 44 mcg per inhalation, 2 inhalations, as needed for asthma symptoms

Crossover sequence 1Crossover sequence 2Crossover sequence 3Crossover sequence 4Crossover sequence 5Crossover sequence 6

Eligibility Criteria

Age12 Months - 59 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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,
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

University of Arizona College of Medicine

Tucson, Arizona, 85724, United States

Location

Children's Hospital & Research Center Oakland

Oakland, California, 94609, United States

Location

UCSF Benioff Children's Hospital

San Francisco, California, 94143, United States

Location

National Jewish Health

Denver, Colorado, 80206, United States

Location

Emory University

Atlanta, Georgia, 30322, United States

Location

Rush University Medical Center/Stroger Hospital

Chicago, Illinois, 60612, United States

Location

Children's Memorial Hospital

Chicago, Illinois, 60614, United States

Location

Children's Hospital, Boston

Boston, Massachusetts, 02115, United States

Location

St. Louis Children's Hospital

St Louis, Missouri, 63110, United States

Location

Rainbow Babies and Children's Hospital, Case Western Reserve University

Cleveland, Ohio, 44106, United States

Location

Children's Hospital of Pittsburgh of UPMC

Pittsburgh, Pennsylvania, 15224, United States

Location

University of Virginia Health System

Charlottesville, Virginia, 22908, United States

Location

University of Wisconsin-Madison

Madison, Wisconsin, 53792, United States

Location

Related Publications (1)

  • 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.

    PMID: 27777180DERIVED

MeSH Terms

Conditions

AsthmaRespiratory Sounds

Interventions

montelukast

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
David Mauger, PhD
Organization
Penn State University Dept of Public Health Sciences
dmauger@psu.edu
717.573.0336

Study Officials

  • William B Busse, MD

    University of Wisconsin, Madison

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, AsthmaNet Data Coordinating Center

Study Record Dates

First Submitted

May 23, 2012

First Posted

May 25, 2012

Study Start

February 1, 2013

Primary Completion

April 1, 2015

Study Completion

April 1, 2015

Last Updated

March 16, 2017

Results First Posted

March 16, 2017

Record last verified: 2017-01

Locations

US(13)