A Study of 2 Doses of MAP0010 in Adult Asthmatics

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00554970

Acronym

P202

Enrollment

Registered

2007-11-07

Start date

2007-11-30

Completion date

2008-03-31

Last updated

2014-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma

Keywords

Adult Asthmatics

Brief 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.

Interventions

DRUGMAP0010 low dose

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

DRUGMAP0010 high dose

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

DRUGBudesonide inhalation suspension 0.25mg

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

DRUGBudesonide inhalation suspension 0.5mg

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

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 45 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Cmax of Budesonide on Day 1 After Administration of MAP0010 Low Dose, MAP0010 High Dose, Pulmicort Respules® 0.25mg, and Pulmicort Respules® 0.5mg	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	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	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	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	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	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.

Countries

United States

Participant flow

Pre-assignment details

This is a 4-treatment, 2-period crossover study. Subjects were randomized to receive either Treatments 1 (MAP0010 low dose) and 2 (Pulmicort Respules® 0.25mg) or 3 (MAP0010 high dose) and 4 (Pulmicort Respules® 0.5mg). Subjects were randomized to the following sequences: Tx 1 then Tx 2, Tx 2 then Tx 1, Tx 3 then Tx 4, or Tx 4 then Tx 3

Participants by arm

Arm	Count
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.	8
Treatment 2, Then Treatment 1 Subjects received Treatment 2 in period 1 followed by a 7 day washout period and then Treatment 1 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.	8
Treatment 3 Then Treatment 4 Subjects received Treatment 3 in period 1 followed by a 7 day washout period and then Treatment 4 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.	8
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.	8
Total	32

Baseline characteristics

Characteristic	Treatment 1 Then Treatment 2	Treatment 2, Then Treatment 1	Treatment 3 Then Treatment 4	Treatment 4 Then Treatment 3	Total
Age, Continuous	27.4 years STANDARD_DEVIATION 8.9	30.4 years STANDARD_DEVIATION 7.2	30.0 years STANDARD_DEVIATION 8.3	29.1 years STANDARD_DEVIATION 6.9	29.2 years STANDARD_DEVIATION 7.6
Sex: Female, Male Female	3 Participants	6 Participants	3 Participants	7 Participants	19 Participants
Sex: Female, Male Male	5 Participants	2 Participants	5 Participants	1 Participants	13 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk	EG003 affected / at risk
deaths Total, all-cause mortality	— / —	— / —	— / —	— / —
other Total, other adverse events	7 / 8	2 / 8	3 / 8	3 / 8
serious Total, serious adverse events	0 / 8	0 / 8	0 / 8	0 / 8

Outcome results

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).

Time frame: Day 1 hour 12