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Tolerability and PK of Submicron Budesonide in Children 4 to 11 Years Old With Mild-To-Moderate Stable Asthma

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00995904
First Posted: October 15, 2009
Last Update Posted: January 9, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
MAP Pharmaceuticals, Inc., a wholly owned subsidiary of Allergan
Information provided by (Responsible Party):
Allergan
  Purpose
This Phase 2 study was to investigate the tolerability of unit dose budesonide (MAP0020) at three doses in pediatric volunteers with a diagnosis and history of mild-to-moderate stable asthma and evaluate the pharmacokinetic profile of budesonide resulting from inhalation aerosol delivery.

Condition Intervention Phase
Asthma Drug: 84ug MAP0020 Drug: 42ug MAP0020 Drug: 21ug MAP0020 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Open-Label, 3-Dose, 3-Period, Crossover Phase 2 Study Investigating the Tolerability and Pharmacokinetics of MAP0010 in Children 4 Through 11 Years Old With a History of Mild-To-Moderate Stable Asthma

Resource links provided by NLM:


Further study details as provided by Allergan:

Primary Outcome Measures:
  • Cmax of Budesonide After Administration of MAP0020 [ Time Frame: 12 hours ]
    The maximum concentration (Cmax) is the highest concentration of a drug measured in the plasma. Plasma is the clear portion of the blood. The Cmax of Budesonide is reported in picograms per milliliter (pg/ml).

  • AUC(0-inf) of Budesonide After Administration of MAP0020 [ Time Frame: 12 hours ]
    The AUC(0-inf) is the area under the plot of plasma concentration of drug to time infinity after drug administration. Budesonide AUC(0-inf) is reported in picograms times minutes per milliliter (pg*min/ml).

  • Half-life (t1/2) of Budesonide After Administration of MAP0020 [ Time Frame: 12 hours ]
    Half-life (t1/2) is the time for the drug to decrease to half of its maximum concentration. Budesonide t1/2 is reported in minutes.


Enrollment: 25
Study Start Date: September 2009
Study Completion Date: November 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment A, then Treatment B, then Treatment C
Study visits were separated by 3-7 day intervals. Treatment A: 84ug MAP0020 (unit dose budesonide delivered by Aeroneb® Go) at Visit 2; Treatment B: 42ug MAP0020 (unit dose budesonide delivered by Aeroneb® Go) at Visit 3; Treatment C: 21ug MAP0020 (unit dose budesonide delivered by Aeroneb® Go) at Visit 4
Drug: 84ug MAP0020
84ug of unit dose budesonide inhalation suspension delivered by Aeroneb® Go (MAP0020) as per protocol
Drug: 42ug MAP0020
42ug of unit dose budesonide inhalation suspension delivered by Aeroneb® Go (MAP0020) as per protocol
Drug: 21ug MAP0020
21ug of unit dose budesonide inhalation suspension delivered by Aeroneb® Go (MAP0020) as per protocol
Experimental: Treatment A, then Treatment C, then Treatment B
Study visits were separated by 3-7 day intervals. Treatment A: 84ug MAP0020 (unit dose budesonide delivered by Aeroneb® Go) at Visit 2; Treatment C: 21ug MAP0020 (unit dose budesonide delivered by Aeroneb® Go) at Visit 3; Treatment B: 42ug MAP0020 (unit dose budesonide delivered by Aeroneb® Go) at Visit 4
Drug: 84ug MAP0020
84ug of unit dose budesonide inhalation suspension delivered by Aeroneb® Go (MAP0020) as per protocol
Drug: 42ug MAP0020
42ug of unit dose budesonide inhalation suspension delivered by Aeroneb® Go (MAP0020) as per protocol
Drug: 21ug MAP0020
21ug of unit dose budesonide inhalation suspension delivered by Aeroneb® Go (MAP0020) as per protocol
Experimental: Treatment B, then Treatment A, then Treatment C
Study visits were separated by 3-7 day intervals. Treatment B: 42ug MAP0020 (unit dose budesonide delivered by Aeroneb® Go) at Visit 2; Treatment A: 84ug MAP0020 (unit dose budesonide delivered by Aeroneb® Go) at Visit 3; Treatment C: 21ug MAP0020 (unit dose budesonide delivered by Aeroneb® Go) at Visit 4
Drug: 84ug MAP0020
84ug of unit dose budesonide inhalation suspension delivered by Aeroneb® Go (MAP0020) as per protocol
Drug: 42ug MAP0020
42ug of unit dose budesonide inhalation suspension delivered by Aeroneb® Go (MAP0020) as per protocol
Drug: 21ug MAP0020
21ug of unit dose budesonide inhalation suspension delivered by Aeroneb® Go (MAP0020) as per protocol
Experimental: Treatment B, then Treatment C, then Treatment A
Study visits were separated by 3-7 day intervals. Treatment B: 42ug MAP0020 (unit dose budesonide delivered by Aeroneb® Go) at Visit 2; Treatment C: 21ug MAP0020 (unit dose budesonide delivered by Aeroneb® Go) at Visit 3; Treatment A: 84ug of unit dose budesonide delivered by Aeroneb® Go (MAP0020) at Visit 4
Drug: 84ug MAP0020
84ug of unit dose budesonide inhalation suspension delivered by Aeroneb® Go (MAP0020) as per protocol
Drug: 42ug MAP0020
42ug of unit dose budesonide inhalation suspension delivered by Aeroneb® Go (MAP0020) as per protocol
Drug: 21ug MAP0020
21ug of unit dose budesonide inhalation suspension delivered by Aeroneb® Go (MAP0020) as per protocol
Experimental: Treatment C, then Treatment A, then Treatment B

Study visits were separated by 3-7 day intervals.

Treatment C: 21ug MAP0020 (unit dose budesonide delivered by Aeroneb® Go) at Visit 2; Treatment A: 84ug MAP0020 (unit dose budesonide delivered by Aeroneb® Go) at Visit 3; Treatment B: 42ug MAP0020 (unit dose budesonide delivered by Aeroneb® Go) at Visit 4

Drug: 84ug MAP0020
84ug of unit dose budesonide inhalation suspension delivered by Aeroneb® Go (MAP0020) as per protocol
Drug: 42ug MAP0020
42ug of unit dose budesonide inhalation suspension delivered by Aeroneb® Go (MAP0020) as per protocol
Drug: 21ug MAP0020
21ug of unit dose budesonide inhalation suspension delivered by Aeroneb® Go (MAP0020) as per protocol
Experimental: Treatment C, then Treatment B, then Treatment A
Study visits were separated by 3-7 day intervals. Treatment C: 21ug of unit dose budesonide delivered by Aeroneb® Go (MAP0020) at Visit 2; Treatment B: 42ug of unit dose budesonide delivered by Aeroneb® Go (MAP0020) at Visit 3; Treatment A: 84ug of unit dose budesonide delivered by Aeroneb® Go (MAP0020) at Visit 4
Drug: 84ug MAP0020
84ug of unit dose budesonide inhalation suspension delivered by Aeroneb® Go (MAP0020) as per protocol
Drug: 42ug MAP0020
42ug of unit dose budesonide inhalation suspension delivered by Aeroneb® Go (MAP0020) as per protocol
Drug: 21ug MAP0020
21ug of unit dose budesonide inhalation suspension delivered by Aeroneb® Go (MAP0020) as per protocol

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   4 Years to 11 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  1. Male or female children with a documented diagnosis of mild-to-moderate persistent asthma (according to the 2007 NIH [EPR] criteria) for at least 1 year prior to screening and medically stable for a minimum of 6 months prior to screening.
  2. Children 4 through 11 years old (up to one day prior to their 12th birthday at randomization).
  3. Body weight >=45 lbs, body mass index (BMI) <=30 kg/m2
  4. ICS users had to have been taking an ICS for >=3 months and on a stable dose for >= 1 month before Visit 1.ICS users had to be stable enough and able to withhold their therapeutic ICS for 24 hours prior to study drug administration,
  5. Subjects already on stable immunotherapy (ie, allergy shots)if not anticipated to change during the study.

Key Exclusion Criteria:

  1. Females of child-bearing potential/menarche.
  2. Diagnosis of any other significant chronic illness or abnormality.
  3. Use of corticosteroids
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00995904


Locations
United States, California
West Coast Clinical Trials LLC
Cypress, California, United States
United States, Texas
Sylvana Research Associates
San Antonio, Texas, United States
Sponsors and Collaborators
Allergan
MAP Pharmaceuticals, Inc., a wholly owned subsidiary of Allergan
Investigators
Principal Investigator: Paul Ratner, MD Sylvana Research Associates
Principal Investigator: Ammar Hatab, MD West Coast Clinical Trials LLC
  More Information

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT00995904     History of Changes
Other Study ID Numbers: MAP0020-CL-P201
First Submitted: October 6, 2009
First Posted: October 15, 2009
Results First Submitted: April 17, 2013
Results First Posted: November 20, 2013
Last Update Posted: January 9, 2014
Last Verified: December 2013

Keywords provided by Allergan:
asthmatic children

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Budesonide
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists