A Study of 2 Doses of MAP0010 and Placebo in Asthmatic Children

NCT00569192 | Completed Phase 3 Results

• 1 other identifier: MAP0010-CL-P301
• Study Type: interventional
• Target: 360
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to examine the safety and efficacy of two doses of MAP0010 versus placebo in asthmatic infants and children, 12 months to 8 years of age, over a 12-week treatment period.

Conditions

Asthma

Keywords

asthmatic children

Outcome Measures

Primary Outcomes (2)

• 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 7 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 12

• 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 7 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 12

Secondary Outcomes (4)

• Change From Baseline in FEV1% Predicted

  baseline, week 12

• Change From Baseline in PEF

  baseline, week 12

• Change From Baseline in Daytime Individual Symptom Scores

  baseline, week 12

• Change From Baseline in Nighttime Individual Symptom Scores

  baseline, week 12

Study Arms (3)

0.25mg MAP0010

EXPERIMENTAL

0.25mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 12 weeks

Drug: 0.25mg MAP0010

Placebo

PLACEBO COMPARATOR

Placebo delivered by nebulization twice daily for 12 weeks

Drug: Placebo

0.135mg MAP0010

EXPERIMENTAL

0.135mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 12 weeks

Drug: 0.135mg MAP0010

Interventions

0.135mg MAP0010 DRUG

0.135mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 12 weeks

0.135mg MAP0010

0.25mg MAP0010 DRUG

0.25mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 12 weeks

0.25mg MAP0010

Placebo DRUG

Placebo delivered by nebulization twice daily for 12 weeks

Placebo

Eligibility Criteria

• Age: 12 Months - 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Male or female asthmatic children with mild to moderate persistent asthma.
• months to 8 years of age.
• For children age 4 to 8 years: Documented diagnosis of asthma at least 3 months prior to Visit 1, per NIH (EPR-3) criteria.
• For infants age 12 to \<48 months old: 2 or more wheezing episodes in past 12 months which lasted \> 1 day and affected sleep.
• AND with at least one major or two minor risk factors.

You may not qualify if:

• Any other significant childhood illness/abnormality or chronic lung disease
• Any history of upper or lower respiratory tract infection, within 2 weeks of screening.
• Any history of acute or severe asthma attack requiring ICU admission or ventilatory support.
• Use of any corticosteroid, including inhaled, parental, intranasal, or topical corticosteroid within 2 weeks of screening.
• Any use of oral corticosteroids within 30 days of screening or prolonged use (\>10 consecutive days) of oral corticosteroids, within 12 weeks of screening.

Sponsors & Collaborators

• Allergan: lead
• MAP Pharmaceuticals, Inc., a wholly owned subsidiary of Allergan: collaborator

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: VP, Scientific Affairs
• Organization: MAP Pharmaceuticals Inc., a wholly owned subsidiary of Allergan

dkellerman@mappharma.com

650-386-3100

Study Officials

• Medical Director

  MAP Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2007
• First Posted: December 7, 2007
• Study Start: December 1, 2007
• Primary Completion: September 1, 2008
• Study Completion: January 1, 2009
• Last Updated: January 9, 2014
• Results First Posted: October 23, 2013

Record last verified: 2013-12