A Study of 2 Doses of MAP0010 in Adult Asthmatics

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Asthma

Intervention / Treatment
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* Drug: MAP0010 low dose
* Drug: MAP0010 high dose
* Drug: Budesonide inhalation suspension 0.25mg
* Drug: Budesonide inhalation suspension 0.5mg


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Treatment 1 then Treatment 2<br>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<br>* a single dose of MAP0010 low dose delivered by nebulization twice daily for 7 days as per protocol<br>Drug: Budesonide inhalation suspension 0.25mg<br>* a single dose of Pulmicort Respules® 0.25mg delivered by nebulization twice daily for 7 days as per protocol<br>* Other names: Pulmicort Respules®;|
| Other: Treatment 2 then Treatment 1<br>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<br>* a single dose of MAP0010 low dose delivered by nebulization twice daily for 7 days as per protocol<br>Drug: Budesonide inhalation suspension 0.25mg<br>* a single dose of Pulmicort Respules® 0.25mg delivered by nebulization twice daily for 7 days as per protocol<br>* Other names: Pulmicort Respules®;|
| Other: Treatment 3 then Treatment 4<br>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<br>* a single dose of MAP0010 high dose delivered by nebulization twice daily for 7 days as per protocol<br>Drug: Budesonide inhalation suspension 0.5mg<br>* a single dose of Pulmicort Respules® 0.5mg dose delivered by nebulization twice daily for 7 days as per protocol<br>* Other names: Pulmicort Respules®;|
| Other: Treatment 4 then Treatment 3<br>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<br>* a single dose of MAP0010 high dose delivered by nebulization twice daily for 7 days as per protocol<br>Drug: Budesonide inhalation suspension 0.5mg<br>* a single dose of Pulmicort Respules® 0.5mg dose delivered by nebulization twice daily for 7 days as per protocol<br>* Other names: Pulmicort Respules®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Adult Asthmatics