Study of MAP0010 in Asthmatic Children and Adolescents

Asthma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00697801
• Other study ID #: MAP0010-CL-P201
• Status: Completed
• Phase: Phase 2
• First received: June 12, 2008
• Last updated: December 9, 2013
• Start date: July 2006
• Est. completion date: December 2006

Study information

• Verified date: December 2013
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 208
• Est. completion date: December 2006
• Est. primary completion date: December 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Year to 18 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• MAP0010 low dose
a single dose of MAP0010 low dose delivered by nebulization twice daily for 6 weeks
• MAP0010 high dose
a single dose of MAP0010 high dose delivered by nebulization twice daily for 6 weeks
• Placebo
Placebo delivered by nebulization twice daily for 6 weeks

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Allergan	MAP Pharmaceuticals, Inc., a wholly owned subsidiary of Allergan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Daytime Composite Symptom Score	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.	baseline, week 6	Yes
Primary	Change From Baseline in Nighttime Composite Symptom Score	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.	baseline, week 6	Yes
Secondary	Change From Baseline in FEV1% Predicted	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).	baseline, week 6	Yes