A Study Investigating the Tolerability and Pharmacokinetics of Submicron Budesonide in Children 4 Through 11 Years Old With a History of Mild-To-Moderate Stable Asthma

This study has been completed.

First Received on October 6, 2009. Last Updated on November 25, 2009 History of Changes

Sponsor:	MAP Pharmaceuticals, Inc.
Information provided by:	MAP Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:	NCT00995904

Purpose

This Phase 2 study will investigate the tolerability of submicron budesonide at three doses in volunteers with a diagnosis and history of mild-to-moderate stable asthma and evaluate the pharmacokinetic profile of budesonide resulting from inhalation aerosol delivery. This study is designed to evaluate the systemic exposure of a new submicron budesonide formulation in a next generation nebulizer.

Condition	Intervention	Phase
Asthma	Drug: submicron budesonide	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Crossover Assignment Masking: 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:

MedlinePlus related topics: Asthma

Drug Information available for: Budesonide

U.S. FDA Resources

Further study details as provided by MAP Pharmaceuticals, Inc.:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Enrollment:	24
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: submicron budesonide	Drug: submicron budesonide inhalation suspension

Eligibility

Ages Eligible for Study:	4 Years to 11 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00995904

Locations

United States, California

Cypress, California, United States
United States, Texas

San Antonio, Texas, United States

Sponsors and Collaborators

MAP Pharmaceuticals, Inc.

More Information

No publications provided

Responsible Party:	VP Clinical Development and Medical Affairs, MAP Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:	NCT00995904 History of Changes
Other Study ID Numbers:	MAP0020-CL-P201
Study First Received:	October 6, 2009
Last Updated:	November 25, 2009
Health Authority:	United States: Food and Drug Administration

Keywords provided by MAP Pharmaceuticals, Inc.:

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
Bronchodilator Agents

Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on February 09, 2012