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Acetaminophen Versus Ibuprofen in Children With Asthma (AVICA)

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:
NCT01606319
First received: May 23, 2012
Last updated: November 17, 2016
Last verified: November 2016
Results First Received: September 13, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Asthma
Wheezing
Interventions: Drug: Acetaminophen
Drug: Ibuprofen

  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
Acetaminophen

acetaminophen given as needed for pain or fever

Acetaminophen: 15 mg/kg every 6 hours as needed

Ibuprofen

ibuprofen given as needed for pain or fever

Ibuprofen: 9.4 mg/kg every 6 hours as needed


Participant Flow:   Overall Study
    Acetaminophen   Ibuprofen
STARTED   150   150 
COMPLETED   116   110 
NOT COMPLETED   34   40 
Lost to Follow-up                17                14 
Withdrawal by Subject                9                12 
Physician Decision                1                2 
Lack of Efficacy                6                8 
Adverse Event                1                4 



  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.
No text entered.

Reporting Groups
  Description
Acetaminophen

acetaminophen given as needed for pain or fever

Acetaminophen: 15 mg/kg every 6 hours as needed

Ibuprofen

ibuprofen given as needed for pain or fever

Ibuprofen: 9.4 mg/kg every 6 hours as needed

Total Total of all reporting groups

Baseline Measures
   Acetaminophen   Ibuprofen   Total 
Overall Participants Analyzed 
[Units: Participants]
 150   150   300 
Age 
[Units: Months]
Mean (Standard Deviation)
 40.3  (12.9)   39.4  (13.6)   39.9  (13.2) 
Gender 
[Units: Participants]
Count of Participants
     
Female      64  42.7%      57  38.0%      121  40.3% 
Male      86  57.3%      93  62.0%      179  59.7% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
     
Hispanic or Latino      35  23.3%      37  24.7%      72  24.0% 
Not Hispanic or Latino      115  76.7%      113  75.3%      228  76.0% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      3   2.0%      2   1.3%      5   1.7% 
Asian      1   0.7%      1   0.7%      2   0.7% 
Native Hawaiian or Other Pacific Islander      3   2.0%      0   0.0%      3   1.0% 
Black or African American      47  31.3%      50  33.3%      97  32.3% 
White      74  49.3%      74  49.3%      148  49.3% 
More than one race      22  14.7%      23  15.3%      45  15.0% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 
Number of urgent care and ED visits in the past year 
[Units: Urgent care/ED visits per year]
Mean (Standard Deviation)
 3.1  (2.5)   3.0  (2.3)   3.1  (2.4) 
Number of Oral Corticosteroid (OCS) courses in the past 6 months 
[Units: OCS courses per 6 months]
Mean (Standard Deviation)
 1  (1.1)   1.2  (1.0)   1.1  (1.1) 
IgE (kU/L) 
[Units: kU/L]
Median (Inter-Quartile Range)
 64 
 (19 to 176) 
 70 
 (24 to 252) 
 70 
 (22 to 208) 
Allergen Test 
[Units: Participants]
     
Positive test   64   62   126 
Negative test   86   88   174 


  Outcome Measures
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1.  Primary:   Exacerbation Frequency   [ Time Frame: last 46 weeks of 48 week treatment period ]

2.  Secondary:   Asthma Control Days   [ Time Frame: last 46 weeks of 48 week treatment period ]

3.  Secondary:   Asthma Rescue Medication Use   [ Time Frame: last 46 weeks of 48 week treatment period ]

4.  Secondary:   Health Care Utilization   [ Time Frame: last 46 weeks of 48 week treatment period ]


  Serious Adverse Events


  Other Adverse Events


  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


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: dave mauger, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier: NCT01606319     History of Changes
Other Study ID Numbers: AsthmaNet 005
1U10HL098115 ( US NIH Grant/Contract Award Number )
Study First Received: May 23, 2012
Results First Received: September 13, 2016
Last Updated: November 17, 2016