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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Sponsor:
Milton S. Hershey Medical Center
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
dave mauger, Milton S. Hershey Medical Center
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Study Type | Interventional |
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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 |
Enrollment | 300 |
Participant Flow
Recruitment Details | |
Pre-assignment Details |
Arm/Group Title | Crossover Sequence 1 | Crossover Sequence 2 | Crossover Sequence 3 | Crossover Sequence 4 | Crossover Sequence 5 | Crossover Sequence 6 |
---|---|---|---|---|---|---|
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daily fluticasone propionate, followed by daily montelukast, followed by as needed fluticasone propionate | daily fluticasone propionate, followed by as needed fluticasone propionate, followed by daily montelukast | daily montelukast, followed by as needed fluticasone propionate, followed by daily fluticasone propionate | daily montelukast, followed by daily fluticasone propionate, followed by as needed fluticasone propionate | as needed fluticasone propionate, followed by daily fluticasone propionate, followed by daily montelukast | as needed fluticasone propionate, followed by daily montelukast, followed by daily fluticasone propionate |
Period Title: Overall Study | ||||||
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 |
Reason Not Completed | ||||||
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
Arm/Group Title | Crossover Sequence 1 | Crossover Sequence 2 | Crossover Sequence 3 | Crossover Sequence 4 | Crossover Sequence 5 | Crossover Sequence 6 | Total | |
---|---|---|---|---|---|---|---|---|
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daily fluticasone propionate, followed by daily montelukast, followed by as needed fluticasone propionate | daily fluticasone propionate, followed by as needed fluticasone propionate, followed by daily montelukast | daily montelukast, followed by as needed fluticasone propionate, followed by daily fluticasone propionate | daily montelukast, followed by daily fluticasone propionate, followed by as needed fluticasone propionate | as needed fluticasone propionate, followed by daily fluticasone propionate, followed by daily montelukast | as needed fluticasone propionate, followed by daily montelukast, followed by daily fluticasone propionate | Total of all reporting groups | |
Overall Number of Baseline Participants | 50 | 49 | 51 | 51 | 52 | 47 | 300 | |
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All randomized participants
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Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
||||||||
Number Analyzed | 50 participants | 49 participants | 51 participants | 51 participants | 52 participants | 47 participants | 300 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, Continuous
Mean (Standard Deviation) Unit of measure: Months |
||||||||
Number Analyzed | 50 participants | 49 participants | 51 participants | 51 participants | 52 participants | 47 participants | 300 participants | |
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
Measure Type: Count of Participants Unit of measure: Participants |
||||||||
Number Analyzed | 50 participants | 49 participants | 51 participants | 51 participants | 52 participants | 47 participants | 300 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%
|
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Ethnicity (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
||||||||
Number Analyzed | 50 participants | 49 participants | 51 participants | 51 participants | 52 participants | 47 participants | 300 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%
|
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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)
Measure Type: Count of Participants Unit of measure: Participants |
||||||||
Number Analyzed | 50 participants | 49 participants | 51 participants | 51 participants | 52 participants | 47 participants | 300 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%
|
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
||||||||
United States | Number Analyzed | 50 participants | 49 participants | 51 participants | 51 participants | 52 participants | 47 participants | 300 participants |
50 | 49 | 51 | 51 | 52 | 47 | 300 | ||
Parental Asthma
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 50 participants | 49 participants | 51 participants | 51 participants | 52 participants | 47 participants | 300 participants |
Present | 30 | 29 | 29 | 32 | 35 | 23 | 178 | |
Not Present | 20 | 20 | 22 | 19 | 17 | 24 | 122 | |
Systemic corticosteroids in past 12 monts
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 50 participants | 49 participants | 51 participants | 51 participants | 52 participants | 47 participants | 300 participants |
Used | 37 | 35 | 37 | 40 | 39 | 36 | 224 | |
Not used | 13 | 14 | 14 | 11 | 13 | 11 | 76 | |
Hospitalized in past 12 months
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 50 participants | 49 participants | 51 participants | 51 participants | 52 participants | 47 participants | 300 participants |
Hospitalized | 9 | 14 | 11 | 6 | 13 | 12 | 65 | |
Not hospitalized | 41 | 35 | 40 | 45 | 39 | 35 | 235 | |
Allergen Test
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 50 participants | 49 participants | 51 participants | 51 participants | 52 participants | 47 participants | 300 participants |
Positive test | 18 | 20 | 20 | 21 | 25 | 17 | 121 | |
Negative test | 32 | 29 | 31 | 30 | 27 | 30 | 179 | |
Eczema
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 50 participants | 49 participants | 51 participants | 51 participants | 52 participants | 47 participants | 300 participants |
Present | 21 | 28 | 27 | 28 | 26 | 30 | 160 | |
Not Present | 29 | 21 | 24 | 23 | 26 | 17 | 140 | |
Blood eosinophils
Median (Inter-Quartile Range) Unit of measure: Number of cells per micro-liter |
||||||||
Number Analyzed | 50 participants | 49 participants | 51 participants | 51 participants | 52 participants | 47 participants | 300 participants | |
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)
|
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Serum IgE
Median (Inter-Quartile Range) Unit of measure: International units per liter |
||||||||
Number Analyzed | 50 participants | 49 participants | 51 participants | 51 participants | 52 participants | 47 participants | 300 participants | |
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)
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Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Results Point of Contact
Name/Title: | David Mauger, PhD |
Organization: | Penn State University Dept of Public Health Sciences |
Phone: | 717.573.0336 |
EMail: | dmauger@psu.edu |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | dave mauger, Milton S. Hershey Medical Center |
ClinicalTrials.gov Identifier: | NCT01606306 |
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 |