A Study of 2 Doses of MAP0010 in Adult Asthmatics

NCT00554970 | Completed Phase 2 Results

• 1 other identifier: MAP0010-CL-P202
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma

Keywords

Adult Asthmatics

Outcome Measures

Primary Outcomes (6)

• 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

Study Arms (4)

Treatment 1 then Treatment 2

OTHER

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; Drug: Budesonide inhalation suspension 0.25mg

Treatment 2 then Treatment 1

OTHER

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; Drug: Budesonide inhalation suspension 0.25mg

Treatment 3 then Treatment 4

OTHER

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; Drug: Budesonide inhalation suspension 0.5mg

Treatment 4 then Treatment 3

OTHER

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; Drug: Budesonide inhalation suspension 0.5mg

Interventions

MAP0010 low dose DRUG

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

Treatment 1 then Treatment 2; Treatment 2 then Treatment 1

MAP0010 high dose DRUG

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

Treatment 3 then Treatment 4; Treatment 4 then Treatment 3

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

Also known as: Pulmicort Respules®

Treatment 1 then Treatment 2; Treatment 2 then Treatment 1

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

Also known as: Pulmicort Respules®

Treatment 3 then Treatment 4; Treatment 4 then Treatment 3

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Male or female adult asthmatics with mild to moderate persistent asthma.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

West Coast Clinical Trials Phase 2-4, LLC

Long Beach, California, 90806, United States

Location

Related Links

• National Institutes of Health

MeSH Terms

Conditions

Asthma

Interventions

Budesonide

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Results Point of Contact

• Title: VP, Scientific Affairs
• Organization: MAP Pharmaceuticals Inc., a wholly owned subsidiary of Allergan

dkellerman@mappharma.com

650-386-3100

Study Officials

• Medical Director

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

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 30, 2007
• First Posted: November 7, 2007
• Study Start: November 1, 2007
• Primary Completion: January 1, 2008
• Study Completion: March 1, 2008
• Last Updated: January 9, 2014
• Results First Posted: October 23, 2013

Record last verified: 2013-12

Locations

US (1)