Trial Outcomes & Findings for Acetaminophen Versus Ibuprofen in Children With Asthma (NCT NCT01606319)
NCT ID: NCT01606319
Last Updated: 2017-01-16
Results Overview
the number of asthma exacerbations requiring systemic corticosteroids
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
300 participants
Primary outcome timeframe
last 46 weeks of 48 week treatment period
Results posted on
2017-01-16
Participant Flow
Participant milestones
| Measure |
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
|
|---|---|---|
|
Overall Study
STARTED
|
150
|
150
|
|
Overall Study
COMPLETED
|
116
|
110
|
|
Overall Study
NOT COMPLETED
|
34
|
40
|
Reasons for withdrawal
| Measure |
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
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
17
|
14
|
|
Overall Study
Withdrawal by Subject
|
9
|
12
|
|
Overall Study
Physician Decision
|
1
|
2
|
|
Overall Study
Lack of Efficacy
|
6
|
8
|
|
Overall Study
Adverse Event
|
1
|
4
|
Baseline Characteristics
Acetaminophen Versus Ibuprofen in Children With Asthma
Baseline characteristics by cohort
| Measure |
Acetaminophen
n=150 Participants
acetaminophen given as needed for pain or fever
Acetaminophen: 15 mg/kg every 6 hours as needed
|
Ibuprofen
n=150 Participants
ibuprofen given as needed for pain or fever
Ibuprofen: 9.4 mg/kg every 6 hours as needed
|
Total
n=300 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
40.3 months
STANDARD_DEVIATION 12.9 • n=5 Participants
|
39.4 months
STANDARD_DEVIATION 13.6 • n=7 Participants
|
39.9 months
STANDARD_DEVIATION 13.2 • n=5 Participants
|
|
Gender
Female
|
64 Participants
n=5 Participants
|
57 Participants
n=7 Participants
|
121 Participants
n=5 Participants
|
|
Gender
Male
|
86 Participants
n=5 Participants
|
93 Participants
n=7 Participants
|
179 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
35 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
72 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
115 Participants
n=5 Participants
|
113 Participants
n=7 Participants
|
228 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
47 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
97 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
74 Participants
n=5 Participants
|
74 Participants
n=7 Participants
|
148 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
22 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Number of urgent care and ED visits in the past year
|
3.1 urgent care/ED visits per year
STANDARD_DEVIATION 2.5 • n=5 Participants
|
3.0 urgent care/ED visits per year
STANDARD_DEVIATION 2.3 • n=7 Participants
|
3.1 urgent care/ED visits per year
STANDARD_DEVIATION 2.4 • n=5 Participants
|
|
Number of Oral Corticosteroid (OCS) courses in the past 6 months
|
1 OCS courses per 6 months
STANDARD_DEVIATION 1.1 • n=5 Participants
|
1.2 OCS courses per 6 months
STANDARD_DEVIATION 1.0 • n=7 Participants
|
1.1 OCS courses per 6 months
STANDARD_DEVIATION 1.1 • n=5 Participants
|
|
IgE (kU/L)
|
64 kU/L
n=5 Participants
|
70 kU/L
n=7 Participants
|
70 kU/L
n=5 Participants
|
|
Allergen Test
Positive test
|
64 participants
n=5 Participants
|
62 participants
n=7 Participants
|
126 participants
n=5 Participants
|
|
Allergen Test
Negative test
|
86 participants
n=5 Participants
|
88 participants
n=7 Participants
|
174 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: last 46 weeks of 48 week treatment periodPopulation: Two participants in the ibuprofen arm dropped out of the study during the first two weeks of the study and were not included in the analysis per the pre-specified analysis plan.
the number of asthma exacerbations requiring systemic corticosteroids
Outcome measures
| Measure |
Acetaminophen
n=150 Participants
acetaminophen given as needed for pain or fever
Acetaminophen: 15 mg/kg every 6 hours as needed
|
Ibuprofen
n=148 Participants
ibuprofen given as needed for pain or fever
Ibuprofen: 9.4 mg/kg every 6 hours as needed
|
|---|---|---|
|
Exacerbation Frequency
|
0.81 asthma exacerbations per 46 weeks
Interval 0.65 to 1.02
|
.87 asthma exacerbations per 46 weeks
Interval 0.69 to 1.1
|
SECONDARY outcome
Timeframe: last 46 weeks of 48 week treatment periodPopulation: Two participants in the ibuprofen arm dropped out of the study during the first two weeks of the study and were not included in the analysis per the pre-specified analysis plan.
proportion of study days on which asthma was controlled, measured by electronic diary
Outcome measures
| Measure |
Acetaminophen
n=150 Participants
acetaminophen given as needed for pain or fever
Acetaminophen: 15 mg/kg every 6 hours as needed
|
Ibuprofen
n=148 Participants
ibuprofen given as needed for pain or fever
Ibuprofen: 9.4 mg/kg every 6 hours as needed
|
|---|---|---|
|
Asthma Control Days
|
.86 proportion of days
Interval 0.84 to 0.88
|
.87 proportion of days
Interval 0.85 to 0.89
|
SECONDARY outcome
Timeframe: last 46 weeks of 48 week treatment periodPopulation: Two participants in the ibuprofen arm dropped out of the study during the first two weeks of the study and were not included in the analysis per the pre-specified analysis plan.
average albuterol rescue use per week, measured by electronic diary
Outcome measures
| Measure |
Acetaminophen
n=150 Participants
acetaminophen given as needed for pain or fever
Acetaminophen: 15 mg/kg every 6 hours as needed
|
Ibuprofen
n=148 Participants
ibuprofen given as needed for pain or fever
Ibuprofen: 9.4 mg/kg every 6 hours as needed
|
|---|---|---|
|
Asthma Rescue Medication Use
|
2.8 inhalations per week
Interval 2.3 to 3.3
|
3 inhalations per week
Interval 2.4 to 3.6
|
SECONDARY outcome
Timeframe: last 46 weeks of 48 week treatment periodPopulation: Two participants in the ibuprofen arm dropped out of the study during the first two weeks of the study and were not included in the analysis per the pre-specified analysis plan.
frequency of unscheduled physician visits, emergency department visits or hospitalizations for asthma
Outcome measures
| Measure |
Acetaminophen
n=150 Participants
acetaminophen given as needed for pain or fever
Acetaminophen: 15 mg/kg every 6 hours as needed
|
Ibuprofen
n=148 Participants
ibuprofen given as needed for pain or fever
Ibuprofen: 9.4 mg/kg every 6 hours as needed
|
|---|---|---|
|
Health Care Utilization
|
.75 unscheduled health visits per 46 weeks
Interval 0.6 to 0.95
|
.76 unscheduled health visits per 46 weeks
Interval 0.6 to 0.97
|
Adverse Events
Acetaminophen
Serious events: 6 serious events
Other events: 135 other events
Deaths: 0 deaths
Ibuprofen
Serious events: 12 serious events
Other events: 124 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Acetaminophen
n=150 participants at risk
acetaminophen given as needed for pain or fever
Acetaminophen: 15 mg/kg every 6 hours as needed
|
Ibuprofen
n=150 participants at risk
ibuprofen given as needed for pain or fever
Ibuprofen: 9.4 mg/kg every 6 hours as needed
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
asthma exacerbation
|
2.7%
4/150 • Number of events 4
|
5.3%
8/150 • Number of events 8
|
|
Respiratory, thoracic and mediastinal disorders
Influenza
|
0.00%
0/150
|
0.67%
1/150 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
0.67%
1/150 • Number of events 1
|
0.00%
0/150
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/150
|
0.67%
1/150 • Number of events 1
|
|
Injury, poisoning and procedural complications
Simple laceration
|
0.67%
1/150 • Number of events 1
|
0.00%
0/150
|
|
Respiratory, thoracic and mediastinal disorders
bronchitis
|
0.00%
0/150
|
0.67%
1/150 • Number of events 1
|
|
Surgical and medical procedures
tonsilitis
|
0.00%
0/150
|
0.67%
1/150 • Number of events 1
|
Other adverse events
| Measure |
Acetaminophen
n=150 participants at risk
acetaminophen given as needed for pain or fever
Acetaminophen: 15 mg/kg every 6 hours as needed
|
Ibuprofen
n=150 participants at risk
ibuprofen given as needed for pain or fever
Ibuprofen: 9.4 mg/kg every 6 hours as needed
|
|---|---|---|
|
Ear and labyrinth disorders
Otitis media NOS
|
24.7%
37/150 • Number of events 56
|
22.7%
34/150 • Number of events 60
|
|
Respiratory, thoracic and mediastinal disorders
Acute uri
|
62.7%
94/150 • Number of events 279
|
48.7%
73/150 • Number of events 198
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
26.0%
39/150 • Number of events 76
|
25.3%
38/150 • Number of events 57
|
|
Infections and infestations
Strep sore throat
|
10.7%
16/150 • Number of events 19
|
8.7%
13/150 • Number of events 14
|
|
General disorders
Fever
|
61.3%
92/150 • Number of events 230
|
50.0%
75/150 • Number of events 176
|
|
General disorders
Headache
|
8.7%
13/150 • Number of events 22
|
10.0%
15/150 • Number of events 33
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
6.7%
10/150 • Number of events 17
|
6.0%
9/150 • Number of events 12
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
21.3%
32/150 • Number of events 55
|
20.0%
30/150 • Number of events 61
|
|
Gastrointestinal disorders
Vomiting
|
11.3%
17/150 • Number of events 18
|
11.3%
17/150 • Number of events 17
|
|
Gastrointestinal disorders
Diarrhea
|
6.7%
10/150 • Number of events 11
|
4.7%
7/150 • Number of events 7
|
Additional Information
David Mauger, PhD
Penn State University Dept of Public Health Sciences
Phone: 717.573.0336
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place