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

Allergan

Status and phase: Completed; Phase 2

Conditions: Asthma

Treatments: Drug: Budesonide inhalation suspension 0.5mg; Drug: MAP0010 low dose; Drug: Budesonide inhalation suspension 0.25mg; Drug: MAP0010 high dose

Study type: Interventional

Funder types: Industry

Identifiers

NCT00554970

MAP0010-CL-P202

Details and patient eligibility

About

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.

Enrollment: 32 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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32 participants in 4 patient groups

Treatment 1 then Treatment 2

Other group

Description:

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.

Treatment:

Drug: Budesonide inhalation suspension 0.25mg

Drug: MAP0010 low dose

Treatment 2 then Treatment 1

Other group

Description:

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.

Treatment:

Drug: Budesonide inhalation suspension 0.25mg

Drug: MAP0010 low dose

Treatment 3 then Treatment 4

Other group

Description:

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.

Treatment:

Drug: Budesonide inhalation suspension 0.5mg

Drug: MAP0010 high dose

Treatment 4 then Treatment 3

Other group

Description:

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.

Treatment:

Drug: Budesonide inhalation suspension 0.5mg

Drug: MAP0010 high dose