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A Study of 2 Doses of MAP0010 in Adult Asthmatics (P202)

This study has been completed.
Sponsor:
Information provided by:
MAP Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00554970
First received: October 30, 2007
Last updated: January 23, 2009
Last verified: January 2009
History of Changes
  Purpose

The purpose of this study is to examine the blood levels of two doses of MAP0010 (a corticosteroid) and two doses of an approved corticosteroid in adult asthma and safety with twice daily dosing over 7 days.


Condition Intervention Phase
Asthma
 Drug: budesonide inhalation suspension
Drug: MAP0010
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized, Open Label, Active-Controlled, 4-Treatment, 2-Period, 2 Parallel Block Crossover Pharmacokinetic and Safety Study of 2 Doses of MAP0010 in Adult Asthmatics

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:
  • To evaluate the pharmacokinetics of inhaled MAP0010 [ Time Frame: Prospective ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To evaluate the tolerability of inhaled MAP0010 [ Time Frame: Prospective ] [ Designated as safety issue: No ]
  • To explore efficacy of inhaled MAP0010 [ Time Frame: Prospective ] [ Designated as safety issue: No ]

Enrollment: 32
Study Start Date: November 2007
Study Completion Date: March 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Treatment 1
Low dose
 Drug: budesonide inhalation suspension
low dose; inhalation; twice daily
Experimental: Treatment 2
MAP0010 low dose
 Drug: MAP0010
Low dose; inhalation; twice daily
Active Comparator: Treatment 3
High dose
 Drug: budesonide inhalation suspension
High dose for inhalation; twice daily
Experimental: Treatment 4
MAP0010 High dose
 Drug: MAP0010
High dose for inhalation; twice daily

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female adult asthmatics with mild to moderate persistent asthma.
  • 18 to 45 (up to the 46th birthday) years of age.
  • Documented diagnosis of asthma at least 3 months prior to Visit 1, per NIH/NHLBI, EPR-3 criteria.
  • Able to withhold short-acting bronchodilators (e.g., albuterol or ipratropium bromide) for at least 4 hours prior to clinic visits.
  • Baseline FEV1 greater than or equal to 50% of predicted normal.

Exclusion Criteria:

  • Any other significant illness/abnormality
  • A history of upper or lower respiratory tract infection within 2 weeks
  • A history of acute or severe asthma attack requiring ICU admission or ventilatory support.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00554970

Locations
United States, California
West Coast Clinical Trials Phase 2-4, LLC
Long Beach, California, United States, 90806
Sponsors and Collaborators
MAP Pharmaceuticals, Inc.
  More Information

Additional Information:
MAP Pharmaceuticals, Inc.  This link exits the ClinicalTrials.gov site
National Institutes of Health  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Alan Cohen/ VP Clinical Development and Medical Affairs, MAP Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00554970     History of Changes
Other Study ID Numbers: MAP0010-CL-P202
Study First Received: October 30, 2007
Last Updated: January 23, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by MAP Pharmaceuticals, Inc.:
Adult Asthmatics

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 June 18, 2013