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Completed

NCT Number: NCT00554970

A Study of 2 Doses of MAP0010 in Adult Asthmatics

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.

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

West Coast Clinical Trials Phase 2-4, LLC

Long Beach, California, 90806, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

MAP0010 low dose

Drug

a single dose of MAP0010 low dose delivered by nebulization twice daily for 7 days as per protocol

MAP0010 high dose

Drug

a single dose of MAP0010 high dose delivered by nebulization twice daily for 7 days as per protocol

Budesonide inhalation suspension 0.25mg

Drug

a single dose of Pulmicort Respules® 0.25mg delivered by nebulization twice daily for 7 days as per protocol

Other names: Pulmicort Respules®

Budesonide inhalation suspension 0.5mg

Drug

a single dose of Pulmicort Respules® 0.5mg dose delivered by nebulization twice daily for 7 days as per protocol

Other names: Pulmicort Respules®

Primary outcomes

  1. 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).

  2. 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).

  3. 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).

  4. 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).

  5. 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.

  6. 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.

Sponsors and collaborators

Lead sponsor

Allergan

Industry

Collaborators

  • MAP Pharmaceuticals, Inc., a wholly owned subsidiary of Allergan

Registry information

Official study 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

Acronym: P202

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Nov 7, 2007
Registry last updated
Jan 9, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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