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Individualized Therapy For Asthma in Toddlers (INFANT)

This study has been completed.
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
dave mauger, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier:
NCT01606306
First received: May 23, 2012
Last updated: January 27, 2017
Last verified: January 2017
History of Changes
Results First Received: September 15, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: 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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

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 ]
  Show Outcome Measure 1


  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 ( US NIH Grant/Contract Award Number )
Study First Received: May 23, 2012
Results First Received: September 15, 2016
Last Updated: January 27, 2017