A Study of 2 Doses of MAP0010 in Adult Asthmatics

Asthma Clinical Trial

— P202  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00554970
• Other study ID #: MAP0010-CL-P202
• Status: Completed
• Phase: Phase 2
• First received: October 30, 2007
• Last updated: December 9, 2013
• Start date: November 2007
• Est. completion date: March 2008

Study information

• Verified date: December 2013
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: March 2008
• Est. primary completion date: January 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• MAP0010 low dose
a single dose of MAP0010 low dose delivered by nebulization twice daily for 7 days as per protocol
• MAP0010 high dose
a single dose of MAP0010 high dose delivered by nebulization twice daily for 7 days as per protocol
• Budesonide inhalation suspension 0.25mg
a single dose of Pulmicort Respules® 0.25mg delivered by nebulization twice daily for 7 days as per protocol
• 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

Locations

Country	Name	City	State
United States	West Coast Clinical Trials Phase 2-4, LLC	Long Beach	California

Sponsors (2)

Lead Sponsor	Collaborator
Allergan	MAP Pharmaceuticals, Inc., a wholly owned subsidiary of Allergan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cmax of Budesonide on Day 1 After Administration of MAP0010 Low Dose, MAP0010 High Dose, Pulmicort Respules® 0.25mg, and Pulmicort Respules® 0.5mg	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).	Day 1 hour 12	No
Primary	Cmax of Budesonide on Day 8 After Administration of MAP0010 Low Dose, MAP0010 High Dose, Pulmicort Respules® 0.25mg, and Pulmicort Respules® 0.5mg	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).	Day 8 hour 12	No
Primary	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	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).	Day 1 hour 12	No
Primary	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	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).	Day 8 hour 12	No
Primary	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	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.	Day 1 hour 12	No
Primary	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	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.	Day 8 hour 12	No

External Links

•   National Institutes of Health