Study of MAP0010 in Asthmatic Children and Adolescents

NCT00697801 | Completed Phase 2 Results

• 1 other identifier: MAP0010-CL-P201
• Study Type: interventional
• Target: 208
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma

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 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

• 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

Secondary Outcomes (1)

• Change From Baseline in FEV1% Predicted

  baseline, week 6

Study Arms (3)

MAP0010 low dose

EXPERIMENTAL

a single dose of MAP0010 low dose delivered by nebulization twice daily for 6 weeks

Drug: MAP0010 low dose

MAP0010 high dose

EXPERIMENTAL

a single dose of MAP0010 high dose delivered by nebulization twice daily for 6 weeks

Drug: MAP0010 high dose

Placebo

PLACEBO COMPARATOR

Placebo delivered by nebulization twice daily for 6 weeks

Drug: Placebo

Interventions

MAP0010 low dose DRUG

a single dose of MAP0010 low dose delivered by nebulization twice daily for 6 weeks

MAP0010 low dose

MAP0010 high dose DRUG

a single dose of MAP0010 high dose delivered by nebulization twice daily for 6 weeks

MAP0010 high dose

Placebo DRUG

Placebo delivered by nebulization twice daily for 6 weeks

Placebo

Eligibility Criteria

• Age: 1 Year - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Male or female asthmatic children/adolescents
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Unknown Facility

San Diego, California, United States

Location

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, Inc., a wholly owned subsidiary of Allergan

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 2
• 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: June 12, 2008
• First Posted: June 16, 2008
• Study Start: July 1, 2006
• Primary Completion: December 1, 2006
• Study Completion: December 1, 2006
• Last Updated: January 9, 2014
• Results First Posted: October 23, 2013

Record last verified: 2013-12

Locations

US (1)