Safety Study in Adolescent and Adult Patients With Asthma

Amphastar Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Asthma

Treatments: Drug: Primatene Mist; Drug: Epinephrine inhalation; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01476904

API-E004-CL-C2

Details and patient eligibility

About

E004-C2 is a continuation of E004-C for safety evaluations with additional 3 months to be able to assess the 6-month safety profile for E004 (epinephrine inhalation) versus placebo in a double-blinded manner.

Enrollment: 208 patients

Sex: All

Ages: 12 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Only subjects who have successfully completed the E004-C study within the last 135 days or those who are actively enrolled in the current study E004-C at the time of the study extension initiation
• Male and female asthma patients aged 12 - 75 years
• 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
• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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208 participants in 3 patient groups, including a placebo group

Arm T

Experimental group

Description:

Arm T is the experimental treatment arm consisting of 2 x 125 mcg/inhalations of epinephrine inhalation, QID, with 4-6 hr intervals

Treatment:

Drug: Epinephrine inhalation

Arm P

Placebo Comparator group

Description:

Arm P is a placebo comparator consisting of 2× 0 mcg of placebo inhalations, QID, with 4-6 hr intervals

Treatment:

Drug: Placebo

Arm A

Active Comparator group

Description:

Arm A is an active comparator, Primatene Mist, consisting of 2× 220 mcg/inhalation, QID, with 4-6 hr intervals

Treatment:

Drug: Primatene Mist