Epinephrine Inhalation Aerosol USP: For Evaluation Of Efficacy And Safety In Asthma Patients

• Status: Completed
• Trial end date: 2011-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This clinical study evaluates the 12-week efficacy and safety of Epinephrine HFA Inhalation Aerosol HFA the proposed HFA formulation of metered dose inhaler (MDI) of Epinephrine, in comparison to a Placebo-HFA control MDI and the currently marketed Primatene® Mist (epinephrine CFC inhaler), in adolescent and adult subjects with asthma.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Amphastar Pharmaceuticals, Inc.
• Treatments: Epinephrine; Epinephryl borate; Racepinephrine

Criteria

Inclusion Criteria:

• Patients with documented asthma, requiring inhaled epinephrine or beta 2-agonist treatment.

• No significant changes in asthma therapy and no asthma-related hospitalization or emergency visits, within 4 weeks prior to Screening

• Can tolerate withholding treatment with inhaled bronchodilators and other allowed medications for the minimum washout period.

• Demonstrating a Screening Baseline FEV1 that is 50 - 90% of predicted normal value.

• Demonstrating at least a 12% Airway Reversibility.

• Demonstrating satisfactory techniques in the use of metered-dose inhaler and a hand held peak expiratory flow meter.

• Female patients of child-bearing potential must be non-pregnant and non-lactating at Screening and throughout the study, and must use an acceptable method of contraception during the study.

Exclusion Criteria:

• A smoking history of 10-pack years, or having smoked within 12 months of screening.

• Any current or past medical conditions that, per investigator discretion, might significantly affect responses to the study drugs, other than asthma.

• Concurrent clinically significant diseases.

• Known intolerance or hypersensitivity to any component of the study drugs.

• Recent infection of the respiratory tract, before screening.

• Use of prohibited medications.

• Having been on other investigational drug/device studies in the last 30 days prior to screening.

• Known or highly suspected substance abuse.