Study of MAP0010 in Asthmatic Children and Adolescents
This study has been completed.
Sponsor:
MAP Pharmaceuticals, Inc.
Information provided by:
MAP Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00697801
First received: June 12, 2008
Last updated: January 23, 2009
Last verified: January 2009
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Purpose
The objectives of this study are to evaluate the efficacy, tolerability and pharmacokinetics of 2 doses of MAP0010 in asthmatic children/adolescents.
| Condition | Intervention | Phase |
|---|---|---|
|
Asthma |
Drug: MAP0010 Drug: Placebo |
Phase 2 |
| Study Type: | Interventional |
| 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 |
Resource links provided by NLM:
Further study details as provided by MAP Pharmaceuticals, Inc.:
Primary Outcome Measures:
- 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 ]
Secondary Outcome Measures:
- 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 ]
| Enrollment: | 208 |
| Study Start Date: | July 2006 |
| Study Completion Date: | December 2006 |
| Primary Completion Date: | December 2006 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 1
MAP0010 low dose
|
Drug: MAP0010
low dose; inhalation; twice daily
|
|
Active Comparator: 2
MAP0010 high dose
|
Drug: MAP0010
high dose; inhalation; twice daily
|
| Placebo Comparator: 3 |
Drug: Placebo
placebo; inhalation; twice daily
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 1 Year to 18 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Male or female asthmatic children/adolescents
- 1 to 18 years of age
- FEV1 greater than or equal to 50% predicted normal (where obtainable)
- Stable but symptomatic
- Diagnosis of asthma (per NIH criteria) at least 3 months before screening OR documented exacerbation or worsening of asthma or symptoms suggestive of asthma including nocturnal asthma, within 6 months of screening OR documented SAB use more than or at least once for symptom relief during the 4 days of run in with a total symptom score greater than or equal to 1 OR greater than or equal to 1 night disturbed due to asthma symptoms in previous month.
Exclusion Criteria:
- Any other significant childhood illness.
- Participated in any investigational clinical trial within the 30 days prior to screening.
- Use of any corticosteroid within 2 weeks of screening.
- Use of oral corticosteroid within 30 days of screening or prolonged use of oral corticosteroids within 12 weeks of screening.
- Use of inhaled long acting bronchodilators.
- Presumptive or documented history of upper or lower respiratory infection within 2 weeks before screening.
- Any history of acute or severe asthma attack requiring ICU admission or ventilatory support.
- History suggestive (or diagnosis) of other concomitant lung disease.
Contacts and Locations More Information
No publications provided
| Responsible Party: | Dr. Alan Cohen/ VP Clinical Development and Medical Affairs, MAP Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00697801 History of Changes |
| Other Study ID Numbers: | MAP0010-CL-P201 |
| Study First Received: | June 12, 2008 |
| Last Updated: | January 23, 2009 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Asthma Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases |
Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases |
ClinicalTrials.gov processed this record on May 23, 2013