Safety and Blood Level Study of Unit Dose Budesonide - Full Text View

Sponsor:	MAP Pharmaceuticals, Inc.
Collaborator:	Q-Pharm Pty Limited
Information provided by:	MAP Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:	NCT00627679

Purpose

The purpose of this study is to study how well three doses of a new formulation of budesonide (for the treatment of asthma) are tolerated by healthy adults compared to a currently approved and marketed formulation, and to examine blood levels of budesonide after the four different doses in each volunteer.

Condition	Intervention	Phase
Asthma	Drug: Budesonide	Phase I

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	A Randomized, Double Blind, Active Controlled, Single Dose, 4 Arm, 4 Period Crossover, Phase 1 Study Investigating the Tolerability and Pharmacokinetics of MAP0010

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:

Tolerability of new nebulized formulation of budesonide [ Time Frame: 8 hours after each of 4 doses ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Pharmacokinetics of budesonide after 3 doses of MAP0010 and 1 of a commercial budesonide formulation all delivered through the same nebulizer system on different days. [ Time Frame: 8 hours after each of 4 doses ] [ Designated as safety issue: Yes ]

Enrollment:	16
Study Start Date:	December 2005
Study Completion Date:	May 2006
Primary Completion Date:	December 2005 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 MAP0010 - high dose	Drug: Budesonide Single dose by nebulization Other Names: Unit Dose Budesonide Pulmicort Respules (0.25mg/2mL)
Experimental: 2 MAP0010 - intermediate dose	Drug: Budesonide Single dose by nebulization Other Names: Unit Dose Budesonide Pulmicort Respules (0.25mg/2mL)
Experimental: 3 MAP0010 - low dose	Drug: Budesonide Single dose by nebulization Other Names: Unit Dose Budesonide Pulmicort Respules (0.25mg/2mL)
Active Comparator: 4 Budesonide Inhalation Suspension (0.25mg/2mL)	Drug: Budesonide Single dose by nebulization Other Names: Unit Dose Budesonide Pulmicort Respules (0.25mg/2mL)

Eligibility

Ages Eligible for Study:	18 Years to 50 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Healthy adult volunteers, aged 18-50 years
BMI less than 30 kg/m2
Non smoker (currently and <10 pack years total if ex-smoker)

Exclusion Criteria:

Any use of corticosteroid in previous 4 weeks
Pregnancy/lactation
Significant blood donation (or testing) in previous 8 weeks

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00627679

Locations

Australia, Queensland
Q-Pharm Pty Limited
Brisbane, Queensland, Australia, QLD 4006

Sponsors and Collaborators

MAP Pharmaceuticals, Inc.

Q-Pharm Pty Limited

Investigators

Principal Investigator:

Joanne Marjason, MBBS

Q-Pharm Pty Limited

More Information

No publications provided

Responsible Party:	Alan Cohen, VP Clinical Development and Medical Affairs, MAP Pharmaceuticals Inc
ClinicalTrials.gov Identifier:	NCT00627679 History of Changes
Other Study ID Numbers:	MAP0010-CL-P101
Study First Received:	February 22, 2008
Last Updated:	January 23, 2009
Health Authority:	Australia: Therapeutic Goods Administration

Keywords provided by MAP Pharmaceuticals, Inc.:

Pediatric asthma

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 12, 2012