AsthmaPhase 3INFANTNCT01606306
Individualized Therapy For Asthma in Toddlers
A Phase 3 study testing daily fluticasone propionate, Montelukast and as-needed fluticasone propionate in people with Asthma and Wheezing, run by Milton S. Hershey Medical Center at 13 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 59 months
- What is being tested?
- daily fluticasone propionate, Montelukast and as-needed fluticasone propionate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 13 sitesUnited States
- Study dates
- Feb 2013to Apr 2015
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 59 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Show all 14Show fewer
- 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.
Who cannot join
- 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),
Show all 17Show fewer
- 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.
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
United States13 sites
Emory University
Atlanta, Georgia, 30322
Children's Hospital, Boston
Boston, Massachusetts, 02115
University of Virginia Health System
Charlottesville, Virginia, 22908
Rush University Medical Center/Stroger Hospital
Chicago, Illinois, 60612
Children's Memorial Hospital
Chicago, Illinois, 60614
Rainbow Babies and Children's Hospital, Case Western Reserve University
Cleveland, Ohio, 44106
National Jewish Health
Denver, Colorado, 80206
University of Wisconsin-Madison
Madison, Wisconsin, 53792
Children's Hospital & Research Center Oakland
Oakland, California, 94609
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, 15224
UCSF Benioff Children's Hospital
San Francisco, California, 94143
St. Louis Children's Hospital
St Louis, Missouri, 63110
University of Arizona College of Medicine
Tucson, Arizona, 85724
About this study
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.
Read the 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.
- Being tested
- daily fluticasone propionate, Montelukast, as-needed fluticasone propionate
- Keywords
- Asthma, Wheezing, Fluticasone, Montelukast, Preschool-age
- Medical subject headings
- Asthma, Respiratory Sounds
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
daily fluticasone propionateDrug
Flovent® HFA, 44 mcg per inhalation, 2 inhalations twice daily
MontelukastDrug
Singulair®, 4 mg granules or chewable tablets by mouth once daily in the evening
as-needed fluticasone propionateDrug
Flovent® HFA, 44 mcg per inhalation, 2 inhalations, as needed for asthma symptoms
| Study group | Role | What they receive |
|---|---|---|
| Crossover sequence 1 | Experimental | daily fluticasone propionate, followed by daily montelukast, followed by as needed fluticasone propionate Receives: Drug: daily fluticasone propionate; Drug: Montelukast; Drug: as-needed fluticasone propionate |
| Crossover sequence 2 | Experimental | daily fluticasone propionate, followed by as needed fluticasone propionate, followed by daily montelukast Receives: Drug: daily fluticasone propionate; Drug: Montelukast; Drug: as-needed fluticasone propionate |
| Crossover sequence 3 | Experimental | daily montelukast, followed by as needed fluticasone propionate, followed by daily fluticasone propionate Receives: Drug: daily fluticasone propionate; Drug: Montelukast; Drug: as-needed fluticasone propionate |
| Crossover sequence 4 | Experimental | daily montelukast, followed by daily fluticasone propionate, followed by as needed fluticasone propionate Receives: Drug: daily fluticasone propionate; Drug: Montelukast; Drug: as-needed fluticasone propionate |
| Crossover sequence 5 | Experimental | as needed fluticasone propionate, followed by daily fluticasone propionate, followed by daily montelukast Receives: Drug: daily fluticasone propionate; Drug: Montelukast; Drug: as-needed fluticasone propionate |
| Crossover sequence 6 | Experimental | as needed fluticasone propionate, followed by daily montelukast, followed by daily fluticasone propionate Receives: Drug: daily fluticasone propionate; Drug: Montelukast; Drug: as-needed fluticasone propionate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: The last 14 weeks of each 16-week treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2012 (estimated)
- Study startFeb 2013
- Primary completionApr 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Milton S. Hershey Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, dave mauger, Milton S. Hershey Medical Center
- Investigators
- William B Busse, MD, Study chair, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01606306
- Sponsor's protocol ID
- AsthmaNet 004
- Other IDs
- 1U10HL098115
- Acronym
- INFANT
- Status last verified
- Jan 2017
- First submitted
- 23 May 2012
- Last updated
- 16 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
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.
PubMed 27777180
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Individualized Therapy For Asthma in Toddlers
- ClinicalTrials.gov ID
- NCT01606306
- Acronym / sponsor ID
- INFANT / AsthmaNet 004
- Keywords
- Asthma, Wheezing, Fluticasone, Montelukast, Preschool-age
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Milton S. Hershey Medical CenterUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Feb 2013
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 25 May 2012 (estimated)
- Results
- Posted 16 Mar 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Crossover sequence 1 | Experimental | Drug: daily fluticasone propionate, Drug: Montelukast, Drug: as-needed fluticasone propionatedaily fluticasone propionate, followed by daily montelukast, followed by as needed fluticasone propionate |
| Crossover sequence 2 | Experimental | Drug: daily fluticasone propionate, Drug: Montelukast, Drug: as-needed fluticasone propionatedaily fluticasone propionate, followed by as needed fluticasone propionate, followed by daily montelukast |
| Crossover sequence 3 | Experimental | Drug: daily fluticasone propionate, Drug: Montelukast, Drug: as-needed fluticasone propionatedaily montelukast, followed by as needed fluticasone propionate, followed by daily fluticasone propionate |
| Crossover sequence 4 | Experimental | Drug: daily fluticasone propionate, Drug: Montelukast, Drug: as-needed fluticasone propionatedaily montelukast, followed by daily fluticasone propionate, followed by as needed fluticasone propionate |
| Crossover sequence 5 | Experimental | Drug: daily fluticasone propionate, Drug: Montelukast, Drug: as-needed fluticasone propionateas needed fluticasone propionate, followed by daily fluticasone propionate, followed by daily montelukast |
| Crossover sequence 6 | Experimental | Drug: daily fluticasone propionate, Drug: Montelukast, Drug: as-needed fluticasone propionateas needed fluticasone propionate, followed by daily montelukast, followed by daily fluticasone propionate |
Who may qualify
- Ages
- 12 to 59 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (14 listed)
- 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:
- 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:
- 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.
Key exclusion criteria (17 listed)
- 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):
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| daily fluticasone propionateFlovent® HFA, 44 mcg per inhalation, 2 inhalations twice daily | Drug | Crossover sequence 1, Crossover sequence 2, Crossover sequence 3, Crossover sequence 4, Crossover sequence 5, Crossover sequence 6 |
| MontelukastSingulair®, 4 mg granules or chewable tablets by mouth once daily in the evening | Drug | Crossover sequence 1, Crossover sequence 2, Crossover sequence 3, Crossover sequence 4, Crossover sequence 5, Crossover sequence 6 |
| as-needed fluticasone propionateFlovent® HFA, 44 mcg per inhalation, 2 inhalations, as needed for asthma symptoms | Drug | Crossover sequence 1, Crossover sequence 2, Crossover sequence 3, Crossover sequence 4, Crossover sequence 5, Crossover sequence 6 |
Primary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 27777180Fitzpatrick 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William B Busse, MD study chair
University of Wisconsin, Madison
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing daily fluticasone propionate, Montelukast and as-needed fluticasone propionate in people with Asthma and Wheezing, run by Milton S. Hershey Medical Center at 13 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Mar 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01606306, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2017.