Individualized Therapy For Asthma in Toddlers (INFANT)

Study Type:	Interventional
Study Design:	Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Conditions:	Asthma; Wheezing
Interventions:	Drug: daily fluticasone propionate; Drug: Montelukast; Drug: as-needed fluticasone propionate

  Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Crossover Sequence 1	daily fluticasone propionate, followed by daily montelukast, followed by as needed fluticasone propionate
Crossover Sequence 2	daily fluticasone propionate, followed by as needed fluticasone propionate, followed by daily montelukast
Crossover Sequence 3	daily montelukast, followed by as needed fluticasone propionate, followed by daily fluticasone propionate
Crossover Sequence 4	daily montelukast, followed by daily fluticasone propionate, followed by as needed fluticasone propionate
Crossover Sequence 5	as needed fluticasone propionate, followed by daily fluticasone propionate, followed by daily montelukast
Crossover Sequence 6	as needed fluticasone propionate, followed by daily montelukast, followed by daily fluticasone propionate

Participant Flow:   Overall Study

	Crossover Sequence 1	Crossover Sequence 2	Crossover Sequence 3	Crossover Sequence 4	Crossover Sequence 5	Crossover Sequence 6
STARTED	50	49	51	51	52	47
Completed First Treatment Period	43	47	47	45	47	44
Completed Second Treatment Period	41	38	43	44	46	41
Completed Third Treatment Period	35	39	37	38	41	36
COMPLETED	35	39	37	38	41	36
NOT COMPLETED	15	10	14	13	11	11
Lack of Efficacy	2	1	4	4	1	2
Adverse Event	1	0	1	1	2	0
Lost to Follow-up	7	4	5	4	3	5
Withdrawal by Subject	4	3	4	4	5	4
Physician Decision	1	2	0	0	0	0

  Baseline Characteristics

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Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All randomized participants

Reporting Groups

	Description
Crossover Sequence 1	daily fluticasone propionate, followed by daily montelukast, followed by as needed fluticasone propionate
Crossover Sequence 2	daily fluticasone propionate, followed by as needed fluticasone propionate, followed by daily montelukast
Crossover Sequence 3	daily montelukast, followed by as needed fluticasone propionate, followed by daily fluticasone propionate
Crossover Sequence 4	daily montelukast, followed by daily fluticasone propionate, followed by as needed fluticasone propionate
Crossover Sequence 5	as needed fluticasone propionate, followed by daily fluticasone propionate, followed by daily montelukast
Crossover Sequence 6	as needed fluticasone propionate, followed by daily montelukast, followed by daily fluticasone propionate
Total	Total of all reporting groups

Baseline Measures

	Crossover Sequence 1	Crossover Sequence 2	Crossover Sequence 3	Crossover Sequence 4	Crossover Sequence 5	Crossover Sequence 6	Total
Overall Participants Analyzed; [Units: Participants]	50	49	51	51	52	47	300
Age; [Units: Participants]; Count of Participants
<=18 years	50 100.0%	49 100.0%	51 100.0%	51 100.0%	52 100.0%	47 100.0%	300 100.0%
Between 18 and 65 years	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
>=65 years	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
Age; [Units: Months]; Mean (Standard Deviation)	38.3 (13.6)	40.7 (12.4)	38.7 (11.6)	38.6 (15.1)	41.7 (12.7)	41.2 (14.0)	39.9 (13.2)
Sex: Female, Male; [Units: Participants]; Count of Participants
Female	20 40.0%	20 40.8%	19 37.3%	21 41.2%	18 34.6%	23 48.9%	121 40.3%
Male	30 60.0%	29 59.2%	32 62.7%	30 58.8%	34 65.4%	24 51.1%	179 59.7%
Ethnicity (NIH/OMB); [Units: Participants]; Count of Participants
Hispanic or Latino	17 34.0%	12 24.5%	10 19.6%	11 21.6%	12 23.1%	10 21.3%	72 24.0%
Not Hispanic or Latino	33 66.0%	37 75.5%	41 80.4%	40 78.4%	40 76.9%	37 78.7%	228 76.0%
Unknown or Not Reported	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
Race (NIH/OMB); [Units: Participants]; Count of Participants
American Indian or Alaska Native	1 2.0%	1 2.0%	0 0.0%	2 3.9%	0 0.0%	1 2.1%	5 1.7%
Asian	2 4.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	2 0.7%
Native Hawaiian or Other Pacific Islander	1 2.0%	0 0.0%	0 0.0%	1 2.0%	1 1.9%	0 0.0%	3 1.0%
Black or African American	11 22.0%	15 30.6%	20 39.2%	13 25.5%	20 38.5%	18 38.3%	97 32.3%
White	25 50.0%	27 55.1%	24 47.1%	30 58.8%	21 40.4%	21 44.7%	148 49.3%
More than one race	10 20.0%	6 12.2%	7 13.7%	5 9.8%	10 19.2%	7 14.9%	45 15.0%
Unknown or Not Reported	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
Region of Enrollment; [Units: Participants]
United States	50	49	51	51	52	47	300
Parental Asthma; [Units: Participants]
Present	30	29	29	32	35	23	178
Not Present	20	20	22	19	17	24	122
Systemic corticosteroids in past 12 monts; [Units: Participants]
Used	37	35	37	40	39	36	224
Not used	13	14	14	11	13	11	76
Hospitalized in past 12 months; [Units: Participants]
Hospitalized	9	14	11	6	13	12	65
Not hospitalized	41	35	40	45	39	35	235
Allergen Test; [Units: Participants]
Positive test	18	20	20	21	25	17	121
Negative test	32	29	31	30	27	30	179
Eczema; [Units: Participants]
Present	21	28	27	28	26	30	160
Not Present	29	21	24	23	26	17	140
Blood eosinophils; [Units: Number of cells per micro-liter]; Median (Inter-Quartile Range)	183; (111 to 435)	234; (153 to 572)	258; (133 to 460)	255; (175 to 457)	308; (184 to 496)	310; (182 to 536)	258; (158 to 492)
Serum IgE; [Units: International units per liter]; Median (Inter-Quartile Range)	67; (25 to 212)	106.5; (22 to 463)	64; (21 to 141)	64; (31 to 143)	87; (19 to 237)	84; (19 to 348)	70; (22 to 208)

  Outcome Measures

1. Primary:

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 ]

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  Serious Adverse Events

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  Other Adverse Events

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  Limitations and Caveats

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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information

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Certain Agreements:  

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact:  

Name/Title: David Mauger, PhD
Organization: Penn State University Dept of Public Health Sciences
phone: 717.573.0336
e-mail: dmauger@psu.edu

Responsible Party:	dave mauger, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier:	NCT01606306 History of Changes
Other Study ID Numbers:	AsthmaNet 004; 1U10HL098115 ( U.S. NIH Grant/Contract )
First Submitted:	May 23, 2012
First Posted:	May 25, 2012
Results First Submitted:	September 15, 2016
Results First Posted:	March 16, 2017
Last Update Posted:	March 16, 2017