Study of MAP0010 in Asthmatic Children and Adolescents

Phase 2

Completed

• Conditions: Asthma
• Interventions: Drug: Placebo; Drug: MAP0010 low dose; Drug: MAP0010 high dose

• Registration Number: NCT00697801
• Lead Sponsor: Allergan

Brief Summary

The objectives of this study are to evaluate the efficacy, tolerability and pharmacokinetics of 2 doses of MAP0010 (Unit Dose Budesonide) in asthmatic children/adolescents.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-07
• Primary Completion: 2006-12
• Study Completion: 2006-12
• Study First Submitted: 2008-06-12
• Study First Submitted QC: 2008-06-13
• Study First Posted: 2008-06-16
• Results First Submitted: 2013-08-19
• Results First Submitted QC: 2013-08-19
• Results First Posted: 2013-10-23
• Status Verified: 2013-12
• Last Update Submitted: 2013-12-09
• Last Update Posted: 2014-01-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 208

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo delivered by nebulization twice daily for 6 weeks
MAP0010 low dose	MAP0010 low dose	a single dose of MAP0010 low dose delivered by nebulization twice daily for 6 weeks
MAP0010 high dose	MAP0010 high dose	a single dose of MAP0010 high dose delivered by nebulization twice daily for 6 weeks

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Nighttime Composite Symptom Score	baseline, week 6	The individual symptoms at each time point to be monitored are: cough, wheeze, and shortness of breath.; The individual symptoms were scored using a four point scale: 0=no symptoms; 1=mild symptoms; 2=moderate symptoms; 3=severe symptoms; Nightly composite symptom score is based on the average of the individual symptom scores for the night. Nightime composite symptom score is defined as average of the last 5 days' nightly composite symptom scores within the last 5 nights immediately preceding the end day of that week. The range for the nighttime composite symptom score is 0 (no symptoms) to 3 (severe symptoms). A negative change indicates an improvement of symptoms and a positive change indicates a worsening of symptoms.
Change From Baseline in Daytime Composite Symptom Score	baseline, week 6	The individual symptoms at each time point to be monitored are: cough, wheeze, and shortness of breath.; The individual symptoms were scored using a four point scale: 0=no symptoms; 1=mild symptoms; 2=moderate symptoms; 3=severe symptoms; Daily composite symptom score is based on the average of the individual symptom scores for a day. Daytime composite symptom score is defined as average of the last 5 days' daily composite symptom scores within the last 5 days immediately preceding the end day of that week. The range for the daytime composite symptom score is 0 (no symptoms) to 3 (severe symptoms). A negative change indicates an improvement of symptoms and a positive change indicates a worsening of symptoms.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in FEV1% Predicted	baseline, week 6	The forced expiratory volume in 1 second (FEV1) is the amount forced of air exhaled in 1 second. The percent predicted is calculated for age, gender, and height. Subjects had to perform at least 3 acceptable maneuvers into a spirometer. An increase indicates an improvement (a greater volume of air expired).