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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

ClinicalTrials.gov processed this record on October 21, 2014