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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00554970
First Posted: November 7, 2007
Last Update Posted: January 9, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
MAP Pharmaceuticals, Inc., a wholly owned subsidiary of Allergan
Information provided by (Responsible Party):
Allergan
  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
Intervention Model: Crossover Assignment
Masking: None (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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT00554970     History of Changes
Other Study ID Numbers: MAP0010-CL-P202
First Submitted: October 30, 2007
First Posted: November 7, 2007
Results First Submitted: August 19, 2013
Results First Posted: October 23, 2013
Last Update Posted: January 9, 2014
Last Verified: December 2013

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