Asthma
Conditions
Keywords
asthmatic children
Brief summary
The purpose of this study is to examine the safety of two doses of MAP0010 in asthmatic children, 12 months to 8 years of age, over a 40-week period.
Interventions
DRUG0.135mg MAP0010
0.135mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 40 weeks
DRUG0.25mg MAP0010
0.25mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 40 weeks
Sponsors
MAP Pharmaceuticals, Inc., a wholly owned subsidiary of Allergan
Allergan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
12 Months to 8 Years
Healthy volunteers
No
Inclusion criteria
* Completed 12 weeks of treatment in the MAP0010-CL-P301 study. * Patient, parent, and guardian (as appropriate) are willing for child to undergo all study procedures and willing to sign the informed consent and assent, as appropriate.
Exclusion criteria
* Less than 80% compliance with either study treatment and/or other study procedures (e.g., completion of symptom e-diary) in the MAP0010-CL-P301 Study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients With Treatment Emergent Adverse Events Related to Study Drug | 40 weeks | 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. |
| Number of Patients Reporting at Least One Treatment Emergent Adverse Event Leading to Study Termination | 40 weeks | 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. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 0.135mg MAP0010 0.135mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 40 weeks | 94 |
| 0.25mg MAP0010 0.25mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 40 weeks | 98 |
| Total | 192 |
Baseline characteristics
| Characteristic | 0.135mg MAP0010 | 0.25mg MAP0010 | Total |
|---|---|---|---|
| Age, Continuous | 5.0 years | 5.0 years | 5.0 years |
| Sex: Female, Male Female | 46 Participants | 37 Participants | 83 Participants |
| Sex: Female, Male Male | 48 Participants | 61 Participants | 109 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 71 / 94 | 85 / 98 |
| serious Total, serious adverse events | 0 / 94 | 1 / 98 |
Outcome results
Primary
Number of Patients Reporting at Least One Treatment Emergent Adverse Event Leading to Study Termination
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.
Time frame: 40 weeks
Population: All patients who received any study drug and who had at least one post safety evaluation were included in the adverse event analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 0.135mg MAP0010 | Number of Patients Reporting at Least One Treatment Emergent Adverse Event Leading to Study Termination | 8 participants |
| 0.25mg MAP0010 | Number of Patients Reporting at Least One Treatment Emergent Adverse Event Leading to Study Termination | 7 participants |
Primary
Number of Patients With Treatment Emergent Adverse Events Related to Study Drug
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.
Time frame: 40 weeks
Population: All patients who received any study drug and who had at least one post safety evaluation were included in the adverse event analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 0.135mg MAP0010 | Number of Patients With Treatment Emergent Adverse Events Related to Study Drug | 6 participants |
| 0.25mg MAP0010 | Number of Patients With Treatment Emergent Adverse Events Related to Study Drug | 4 participants |