Study of MAP0010 in Asthmatic Children and Adolescents

This study has been completed.
Sponsor:
Collaborator:
MAP Pharmaceuticals, Inc., a wholly owned subsidiary of Allergan
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT00697801
First received: June 12, 2008
Last updated: December 9, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention Phase
Asthma
Drug: MAP0010 low dose
Drug: MAP0010 high dose
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 Allergan:

Primary Outcome Measures:
  • Change From Baseline in Daytime Composite Symptom Score [ Time Frame: baseline, week 6 ] [ Designated as safety issue: Yes ]

    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.


  • Change From Baseline in Nighttime Composite Symptom Score [ Time Frame: baseline, week 6 ] [ Designated as safety issue: Yes ]

    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.



Secondary Outcome Measures:
  • Change From Baseline in FEV1% Predicted [ Time Frame: baseline, week 6 ] [ Designated as safety issue: Yes ]
    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).


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

  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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00697801

Locations
United States, California
San Diego, California, United States
Sponsors and Collaborators
Allergan
MAP Pharmaceuticals, Inc., a wholly owned subsidiary of Allergan
Investigators
Study Director: Medical Director MAP Pharmaceuticals, Inc., a wholly owned subsidiary of Allergan
  More Information

No publications provided

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT00697801     History of Changes
Other Study ID Numbers: MAP0010-CL-P201
Study First Received: June 12, 2008
Results First Received: August 19, 2013
Last Updated: December 9, 2013
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 April 15, 2014