Trial Outcomes & Findings for A Study of 2 Doses of MAP0010 in Asthmatic Children (NCT NCT00697697)
NCT ID: NCT00697697
Last Updated: 2014-01-09
Results Overview
A treatment emergent adverse event is one with a start date on or after the date of first administration of the study drug during the study.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
192 participants
Primary outcome timeframe
40 weeks
Results posted on
2014-01-09
Participant Flow
Participant milestones
| Measure |
0.135mg MAP0010
0.135mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 40 weeks
|
0.25mg MAP0010
0.25mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 40 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
94
|
98
|
|
Overall Study
COMPLETED
|
45
|
44
|
|
Overall Study
NOT COMPLETED
|
49
|
54
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of 2 Doses of MAP0010 in Asthmatic Children
Baseline characteristics by cohort
| Measure |
0.135mg MAP0010
n=94 Participants
0.135mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 40 weeks
|
0.25mg MAP0010
n=98 Participants
0.25mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 40 weeks
|
Total
n=192 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
5.0 years
n=5 Participants
|
5.0 years
n=7 Participants
|
5.0 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
46 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
83 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
48 Participants
n=5 Participants
|
61 Participants
n=7 Participants
|
109 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 40 weeksPopulation: All patients who received any study drug and who had at least one post safety evaluation were included in the adverse event analysis.
A treatment emergent adverse event is one with a start date on or after the date of first administration of the study drug during the study.
Outcome measures
| Measure |
0.135mg MAP0010
n=94 Participants
0.135mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 40 weeks
|
0.25mg MAP0010
n=98 Participants
0.25mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 40 weeks
|
|---|---|---|
|
Number of Patients With Treatment Emergent Adverse Events Related to Study Drug
|
6 participants
|
4 participants
|
PRIMARY outcome
Timeframe: 40 weeksPopulation: All patients who received any study drug and who had at least one post safety evaluation were included in the adverse event analysis.
A treatment emergent adverse event is one with a start date on or after the date of first administration of the study drug during the study.
Outcome measures
| Measure |
0.135mg MAP0010
n=94 Participants
0.135mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 40 weeks
|
0.25mg MAP0010
n=98 Participants
0.25mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 40 weeks
|
|---|---|---|
|
Number of Patients Reporting at Least One Treatment Emergent Adverse Event Leading to Study Termination
|
8 participants
|
7 participants
|
Adverse Events
0.135mg MAP0010
Serious events: 0 serious events
Other events: 71 other events
Deaths: 0 deaths
0.25mg MAP0010
Serious events: 1 serious events
Other events: 85 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
0.135mg MAP0010
n=94 participants at risk
0.135mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 40 weeks
|
0.25mg MAP0010
n=98 participants at risk
0.25mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 40 weeks
|
|---|---|---|
|
Reproductive system and breast disorders
Acquired hydrocele
|
0.00%
0/94
All patients who received any study drug and who had at least one post safety evaluation were included in the adverse event analysis.
|
1.0%
1/98
All patients who received any study drug and who had at least one post safety evaluation were included in the adverse event analysis.
|
Other adverse events
| Measure |
0.135mg MAP0010
n=94 participants at risk
0.135mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 40 weeks
|
0.25mg MAP0010
n=98 participants at risk
0.25mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 40 weeks
|
|---|---|---|
|
General disorders
Pyrexia
|
4.3%
4/94
All patients who received any study drug and who had at least one post safety evaluation were included in the adverse event analysis.
|
12.2%
12/98
All patients who received any study drug and who had at least one post safety evaluation were included in the adverse event analysis.
|
|
Infections and infestations
Pharyngitis
|
2.1%
2/94
All patients who received any study drug and who had at least one post safety evaluation were included in the adverse event analysis.
|
6.1%
6/98
All patients who received any study drug and who had at least one post safety evaluation were included in the adverse event analysis.
|
|
Infections and infestations
Pharyngitis streptococcal
|
10.6%
10/94
All patients who received any study drug and who had at least one post safety evaluation were included in the adverse event analysis.
|
5.1%
5/98
All patients who received any study drug and who had at least one post safety evaluation were included in the adverse event analysis.
|
|
Infections and infestations
Rhinitis
|
2.1%
2/94
All patients who received any study drug and who had at least one post safety evaluation were included in the adverse event analysis.
|
5.1%
5/98
All patients who received any study drug and who had at least one post safety evaluation were included in the adverse event analysis.
|
|
Infections and infestations
Sinusitis
|
7.4%
7/94
All patients who received any study drug and who had at least one post safety evaluation were included in the adverse event analysis.
|
2.0%
2/98
All patients who received any study drug and who had at least one post safety evaluation were included in the adverse event analysis.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
18.1%
17/94
All patients who received any study drug and who had at least one post safety evaluation were included in the adverse event analysis.
|
32.7%
32/98
All patients who received any study drug and who had at least one post safety evaluation were included in the adverse event analysis.
|
|
Infections and infestations
Viral Infection
|
3.2%
3/94
All patients who received any study drug and who had at least one post safety evaluation were included in the adverse event analysis.
|
5.1%
5/98
All patients who received any study drug and who had at least one post safety evaluation were included in the adverse event analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
20.2%
19/94
All patients who received any study drug and who had at least one post safety evaluation were included in the adverse event analysis.
|
12.2%
12/98
All patients who received any study drug and who had at least one post safety evaluation were included in the adverse event analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.3%
4/94
All patients who received any study drug and who had at least one post safety evaluation were included in the adverse event analysis.
|
6.1%
6/98
All patients who received any study drug and who had at least one post safety evaluation were included in the adverse event analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis Allergic
|
3.2%
3/94
All patients who received any study drug and who had at least one post safety evaluation were included in the adverse event analysis.
|
11.2%
11/98
All patients who received any study drug and who had at least one post safety evaluation were included in the adverse event analysis.
|
|
Gastrointestinal disorders
Gastritis
|
1.1%
1/94
All patients who received any study drug and who had at least one post safety evaluation were included in the adverse event analysis.
|
5.1%
5/98
All patients who received any study drug and who had at least one post safety evaluation were included in the adverse event analysis.
|
|
Infections and infestations
Nasopharyngitis
|
5.3%
5/94
All patients who received any study drug and who had at least one post safety evaluation were included in the adverse event analysis.
|
4.1%
4/98
All patients who received any study drug and who had at least one post safety evaluation were included in the adverse event analysis.
|
|
Infections and infestations
Otitis Media
|
4.3%
4/94
All patients who received any study drug and who had at least one post safety evaluation were included in the adverse event analysis.
|
5.1%
5/98
All patients who received any study drug and who had at least one post safety evaluation were included in the adverse event analysis.
|
Additional Information
VP, Scientific Affairs
MAP Pharmaceuticals, Inc. a wholly owned subsidiary of Allergan
Phone: 650-386-3100
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
- Publication restrictions are in place
Restriction type: OTHER