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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:
Collaborator:
MAP Pharmaceuticals, Inc., a wholly owned subsidiary of Allergan
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT00995904
First received: October 6, 2009
Last updated: December 9, 2013
Last verified: December 2013

October 6, 2009
December 9, 2013
September 2009
November 2009   (final data collection date for primary outcome measure)
  • Cmax of Budesonide After Administration of MAP0020 [ Time Frame: 12 hours ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.
Evaluate the pharmacokinetic profile of submicron budesonide resulting from inhalation aerosol delivery. The following pharmacokinetic parameters computed include Cmax, tmax, AUC0-last, AUC0-12, AUC1-inf, CL, kel, t ½, λ, and relative bioavailability. [ Time Frame: 2-4 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00995904 on ClinicalTrials.gov Archive Site
Not Provided
Evaluate the safety and tolerability (adverse events) of a single dose of submicron budesonide via inhalation aerosol delivery. [ Time Frame: 2-4 months ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Tolerability and PK of Submicron Budesonide in Children 4 to 11 Years Old With Mild-To-Moderate Stable Asthma
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

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Asthma
  • 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 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
    Interventions:
    • Drug: 84ug MAP0020
    • Drug: 42ug MAP0020
    • Drug: 21ug MAP0020
  • 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
    Interventions:
    • Drug: 84ug MAP0020
    • Drug: 42ug MAP0020
    • Drug: 21ug MAP0020
  • 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
    Interventions:
    • Drug: 84ug MAP0020
    • Drug: 42ug MAP0020
    • Drug: 21ug MAP0020
  • 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
    Interventions:
    • Drug: 84ug MAP0020
    • Drug: 42ug MAP0020
    • Drug: 21ug MAP0020
  • 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

    Interventions:
    • Drug: 84ug MAP0020
    • Drug: 42ug MAP0020
    • Drug: 21ug MAP0020
  • 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
    Interventions:
    • Drug: 84ug MAP0020
    • Drug: 42ug MAP0020
    • Drug: 21ug MAP0020
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
25
November 2009
November 2009   (final data collection date for primary outcome measure)

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
Both
4 Years to 11 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00995904
MAP0020-CL-P201
No
Allergan
Allergan
MAP Pharmaceuticals, Inc., a wholly owned subsidiary of Allergan
Principal Investigator: Paul Ratner, MD Sylvana Research Associates
Principal Investigator: Ammar Hatab, MD West Coast Clinical Trials LLC
Allergan
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP