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

NCT00995904 | Completed Phase 2 Results

• 1 other identifier: MAP0020-CL-P201
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Asthma

Keywords

asthmatic children

Outcome Measures

Primary Outcomes (3)

• Cmax of Budesonide After Administration of MAP0020

  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).

  12 hours

• AUC(0-inf) of Budesonide After Administration of MAP0020

  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).

  12 hours

• Half-life (t1/2) of Budesonide After Administration of MAP0020

  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.

  12 hours

Study Arms (6)

Treatment A, then Treatment B, then Treatment C

EXPERIMENTAL

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; Drug: 42ug MAP0020; Drug: 21ug MAP0020

Treatment A, then Treatment C, then Treatment B

EXPERIMENTAL

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; Drug: 42ug MAP0020; Drug: 21ug MAP0020

Treatment B, then Treatment A, then Treatment C

EXPERIMENTAL

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; Drug: 42ug MAP0020; Drug: 21ug MAP0020

Treatment B, then Treatment C, then Treatment A

EXPERIMENTAL

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; Drug: 42ug MAP0020; Drug: 21ug MAP0020

Treatment C, then Treatment A, then Treatment B

EXPERIMENTAL

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; Drug: 42ug MAP0020; Drug: 21ug MAP0020

Treatment C, then Treatment B, then Treatment A

EXPERIMENTAL

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; Drug: 42ug MAP0020; Drug: 21ug MAP0020

Interventions

84ug MAP0020 DRUG

84ug of unit dose budesonide inhalation suspension delivered by Aeroneb® Go (MAP0020) as per protocol

Treatment A, then Treatment B, then Treatment C; Treatment A, then Treatment C, then Treatment B; Treatment B, then Treatment A, then Treatment C; Treatment B, then Treatment C, then Treatment A; Treatment C, then Treatment A, then Treatment B; Treatment C, then Treatment B, then Treatment A

42ug MAP0020 DRUG

42ug of unit dose budesonide inhalation suspension delivered by Aeroneb® Go (MAP0020) as per protocol

Treatment A, then Treatment B, then Treatment C; Treatment A, then Treatment C, then Treatment B; Treatment B, then Treatment A, then Treatment C; Treatment B, then Treatment C, then Treatment A; Treatment C, then Treatment A, then Treatment B; Treatment C, then Treatment B, then Treatment A

21ug MAP0020 DRUG

21ug of unit dose budesonide inhalation suspension delivered by Aeroneb® Go (MAP0020) as per protocol

Treatment A, then Treatment B, then Treatment C; Treatment A, then Treatment C, then Treatment B; Treatment B, then Treatment A, then Treatment C; Treatment B, then Treatment C, then Treatment A; Treatment C, then Treatment A, then Treatment B; Treatment C, then Treatment B, then Treatment A

Eligibility Criteria

• Age: 4 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.
• Children 4 through 11 years old (up to one day prior to their 12th birthday at randomization).
• Body weight \>=45 lbs, body mass index (BMI) \<=30 kg/m2
• 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,
• Subjects already on stable immunotherapy (ie, allergy shots)if not anticipated to change during the study.

You may not qualify if:

• Females of child-bearing potential/menarche.
• Diagnosis of any other significant chronic illness or abnormality.
• Use of corticosteroids

Sponsors & Collaborators

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

Study Sites (2)

West Coast Clinical Trials LLC

Cypress, California, United States

Location

Sylvana Research Associates

San Antonio, Texas, 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

• Paul Ratner, MD

  Sylvana Research Associates

  PRINCIPAL INVESTIGATOR

• Ammar Hatab, MD

  West Coast Clinical Trials LLC

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2009
• First Posted: October 15, 2009
• Study Start: September 1, 2009
• Primary Completion: November 1, 2009
• Study Completion: November 1, 2009
• Last Updated: January 9, 2014
• Results First Posted: November 20, 2013

Record last verified: 2013-12

Locations

US (2)