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

This study has been completed.
Sponsor:
Collaborator:
MAP Pharmaceuticals, Inc., a wholly owned subsidiary of Allergan
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT00554970
First received: October 30, 2007
Last updated: December 9, 2013
Last verified: December 2013
  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: MAP0010 low dose
Drug: MAP0010 high dose
Drug: Budesonide inhalation suspension 0.25mg
Drug: Budesonide inhalation suspension 0.5mg
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:


Further study details as provided by Allergan:

Primary Outcome Measures:
  • Cmax of Budesonide on Day 1 After Administration of MAP0010 Low Dose, MAP0010 High Dose, Pulmicort Respules® 0.25mg, and Pulmicort Respules® 0.5mg [ Time Frame: Day 1 hour 12 ] [ Designated as safety issue: No ]
    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).

  • Cmax of Budesonide on Day 8 After Administration of MAP0010 Low Dose, MAP0010 High Dose, Pulmicort Respules® 0.25mg, and Pulmicort Respules® 0.5mg [ Time Frame: Day 8 hour 12 ] [ Designated as safety issue: No ]
    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).

  • AUC(0-inf) of Budesonide on Day 1 After Administration of MAP0010 Low Dose, MAP0010 High Dose, Pulmicort Respules® 0.25mg, and Pulmicort Respules® 0.5mg [ Time Frame: Day 1 hour 12 ] [ Designated as safety issue: No ]
    The AUC(0-inf) is the area under the plot of plasma concentration of drug against time after drug administration. Budesonide AUC(0-inf) is reported in picograms times minutes per milliliter (pg*min/ml).

  • AUC(0-inf) of Budesonide on Day 8 After Administration of MAP0010 Low Dose, MAP0010 High Dose, Pulmicort Respules® 0.25mg, and Pulmicort Respules® 0.5mg [ Time Frame: Day 8 hour 12 ] [ Designated as safety issue: No ]
    The AUC(0-inf) is the area under the plot of plasma concentration of drug against time after drug administration. Budesonide AUC(0-inf) is reported in picograms times minutes per milliliter (pg*min/ml).

  • Half-life (t1/2) of Budesonide on Day 1 After Administration of MAP0010 Low Dose, MAP0010 High Dose, Pulmicort Respules® 0.25mg, and Pulmicort Respules® 0.5mg [ Time Frame: Day 1 hour 12 ] [ Designated as safety issue: No ]
    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.

  • Half-life (t1/2) of Budesonide on Day 8 After Administration of MAP0010 Low Dose, MAP0010 High Dose, Pulmicort Respules® 0.25mg, and Pulmicort Respules® 0.5mg [ Time Frame: Day 8 hour 12 ] [ Designated as safety issue: No ]
    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.


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
Treatment 1 then Treatment 2
Subjects received Treatment 1 in period 1 followed by a 7 day washout period and then Treatment 2 in period 2. Treatment 1 was a single dose of MAP0010 low dose delivered by nebulization twice daily for 7 days as per protocol. Treatment 2 was a single dose of Pulmicort Respules® 0.25mg dose delivered by nebulization twice daily for 7 days as per protocol.
Drug: MAP0010 low dose
a single dose of MAP0010 low dose delivered by nebulization twice daily for 7 days as per protocol
Drug: Budesonide inhalation suspension 0.25mg
a single dose of Pulmicort Respules® 0.25mg delivered by nebulization twice daily for 7 days as per protocol
Other Name: Pulmicort Respules®
Treatment 2 then Treatment 1
Subjects received Treatment 2 in period 1 followed by a 7 day washout period and then Treatment 1 period 2. Treatment 1 was a single dose of MAP0010 low dose delivered by nebulization twice daily for 7 days as per protocol. Treatment 2 was a single dose of Pulmicort Respules® 0.25mg dose delivered by nebulization twice daily for 7 days as per protocol.
Drug: MAP0010 low dose
a single dose of MAP0010 low dose delivered by nebulization twice daily for 7 days as per protocol
Drug: Budesonide inhalation suspension 0.25mg
a single dose of Pulmicort Respules® 0.25mg delivered by nebulization twice daily for 7 days as per protocol
Other Name: Pulmicort Respules®
Treatment 3 then Treatment 4
Subjects received Treatment 3 in period 1 followed by a 7 day washout period and then Treatment 4 period 2. Treatment 3 was a single dose of MAP0010 high dose delivered by nebulization twice daily for 7 days as per protocol. Treatment 4 was a single dose of Pulmicort Respules® 0.5mg dose delivered by nebulization twice daily for 7 days as per protocol.
Drug: MAP0010 high dose
a single dose of MAP0010 high dose delivered by nebulization twice daily for 7 days as per protocol
Drug: Budesonide inhalation suspension 0.5mg
a single dose of Pulmicort Respules® 0.5mg dose delivered by nebulization twice daily for 7 days as per protocol
Other Name: Pulmicort Respules®
Treatment 4 then Treatment 3
Subjects received Treatment 4 in period 1 followed by a 7 day washout period and then Treatment 3 in period 2. Treatment 3 was a single dose of MAP0010 high dose delivered by nebulization twice daily for 7 days as per protocol. Treatment 4 was a single dose of Pulmicort Respules® 0.5mg dose delivered by nebulization twice daily for 7 days as per protocol.
Drug: MAP0010 high dose
a single dose of MAP0010 high dose delivered by nebulization twice daily for 7 days as per protocol
Drug: Budesonide inhalation suspension 0.5mg
a single dose of Pulmicort Respules® 0.5mg dose delivered by nebulization twice daily for 7 days as per protocol
Other Name: Pulmicort Respules®

  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
Allergan
MAP Pharmaceuticals, Inc., a wholly owned subsidiary of Allergan
Investigators
Study Director: Medical Director MAP Pharmaceuticals, Inc., a wholly owned subsidiary of Allergan
  More Information

Additional Information:
No publications provided

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT00554970     History of Changes
Other Study ID Numbers: MAP0010-CL-P202
Study First Received: October 30, 2007
Results First Received: August 19, 2013
Last Updated: December 9, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Allergan:
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 April 16, 2014