Individualized Therapy For Asthma in Toddlers (INFANT)
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ClinicalTrials.gov Identifier: NCT01606306 |
Recruitment Status :
Completed
First Posted : May 25, 2012
Results First Posted : March 16, 2017
Last Update Posted : March 16, 2017
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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:
- Daily inhaled corticosteroid (ICS) treatment,
- Daily leukotriene receptor antagonist (LTRA) treatment, and
- As-needed ICS plus short-acting beta agonist (as-needed ICS/SABA) rescue treatment.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Asthma Wheezing | Drug: daily fluticasone propionate Drug: Montelukast Drug: as-needed fluticasone propionate | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 300 participants |
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 |
Study Start Date : | February 2013 |
Actual Primary Completion Date : | April 2015 |
Actual Study Completion Date : | April 2015 |
Arm | Intervention/treatment |
---|---|
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 |
- 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.

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Ages Eligible for Study: | 12 Months to 59 Months (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 12-59 months of age.
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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.
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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),
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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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01606306
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 |
Study Chair: | William B Busse, MD | University of Wisconsin, Madison |
Responsible Party: | dave mauger, Principal Investigator, AsthmaNet Data Coordinating Center, Milton S. Hershey Medical Center |
ClinicalTrials.gov Identifier: | NCT01606306 |
Other Study ID Numbers: |
AsthmaNet 004 1U10HL098115 ( U.S. NIH Grant/Contract ) |
First Posted: | May 25, 2012 Key Record Dates |
Results First Posted: | March 16, 2017 |
Last Update Posted: | March 16, 2017 |
Last Verified: | January 2017 |
Asthma Wheezing Fluticasone Montelukast Preschool-age |
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 Fluticasone Xhance 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 |