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Safety and Blood Level Study of Unit Dose Budesonide (UDB P101)

This study has been completed.
Sponsor:
Collaborator:
Q-Pharm Pty Limited
Information provided by:
MAP Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00627679
First received: February 22, 2008
Last updated: January 23, 2009
Last verified: January 2009
History of Changes
  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 1

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 May 22, 2013