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

Asthma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00995904
• Other study ID #: MAP0020-CL-P201
• Status: Completed
• Phase: Phase 2
• First received: October 6, 2009
• Last updated: December 9, 2013
• Start date: September 2009
• Est. completion date: November 2009

Study information

• Verified date: December 2013
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: November 2009
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 4 Years to 11 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• 84ug MAP0020
84ug of unit dose budesonide inhalation suspension delivered by Aeroneb® Go (MAP0020) as per protocol
• 42ug MAP0020
42ug of unit dose budesonide inhalation suspension delivered by Aeroneb® Go (MAP0020) as per protocol
• 21ug MAP0020
21ug of unit dose budesonide inhalation suspension delivered by Aeroneb® Go (MAP0020) as per protocol

Locations

Country	Name	City	State
United States	West Coast Clinical Trials LLC	Cypress	California
United States	Sylvana Research Associates	San Antonio	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Allergan	MAP Pharmaceuticals, Inc., a wholly owned subsidiary of Allergan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No