Study of MAP0010 in Asthmatic Children and Adolescents
The objectives of this study are to evaluate the efficacy, tolerability and pharmacokinetics of 2 doses of MAP0010 in asthmatic children/adolescents.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
|Official Title:||A Randomized, Double Blind, Placebo Controlled, 3 Arm, Parallel Group, Phase 2 Study Investigating the Efficacy, Tolerability and Pharmacokinetics of MAP0010 in Asthmatic Children and Adolescents Over 6 Weeks|
- Primary efficacy for this study is change from baseline in night and day symptom composite scores. The individual symptoms at each timepoint to be monitored are: cough, wheeze and breathlessness. [ Time Frame: complete ] [ Designated as safety issue: No ]
- Subjects able to perform PFTs, and whose baseline FEV1 is 50-<80% of predicted normal AND who demonstrate FEV1 reversibility of greater than or equal to 12% at V1 or documented in medical records will have change in clinic FEV1 from baseline analyzed. [ Time Frame: complete ] [ Designated as safety issue: No ]
- Other efficacy measures of interest will include: days and nights free of each and all symptoms; day and night use of rescue medication and days and nights rescue-free. [ Time Frame: complete ] [ Designated as safety issue: No ]
- Subjects aged 6 and over able to perform reproducible peak expiratory flow (PEF) readings will be required to record their PEF at home, on rising in the morning and before retiring to bed in the evenings. [ Time Frame: complete ] [ Designated as safety issue: No ]
- Safety will be assessed by examining clinical adverse events, vital signs, clinical lab tests and spirometry. [ Time Frame: complete ] [ Designated as safety issue: Yes ]
- Pharmacokinetics: Plasma Cmax, Tmax, AUC0-3, AUC-inf, and t1/2 parameters will be estimated for both active treatment groups. [ Time Frame: complete ] [ Designated as safety issue: No ]
|Study Start Date:||July 2006|
|Study Completion Date:||December 2006|
|Primary Completion Date:||December 2006 (Final data collection date for primary outcome measure)|
Active Comparator: 1
MAP0010 low dose
low dose; inhalation; twice daily
Active Comparator: 2
MAP0010 high dose
high dose; inhalation; twice daily
|Placebo Comparator: 3||
placebo; inhalation; twice daily
This is a randomized, double blind, placebo controlled, 3 arm, parallel group, phase 2 study of MAP0010(UDB)in asthmatic children.
Subjects who meet the study entrance criteria will be randomized to one of three treatment groups and receive their first and selected other doses under supervision in the clinic.
All subjects will complete 6 weeks of dosing, with diary card data collection throughout and clinic lung function tests (in children of appropriate age and ability) at start, during and end of study treatment period.