Safety Study in Adolescent and Adult Patients With Asthma

This study has been completed.
Information provided by (Responsible Party):
Amphastar Pharmaceuticals, Inc. Identifier:
First received: November 15, 2011
Last updated: July 9, 2013
Last verified: July 2013

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 versus placebo in a double-blinded manner

Condition Intervention Phase
Drug: Placebo
Drug: Primatene Mist
Drug: Epinephrine inhalation aerosol, HFA
Drug: epinephrine inhalation aerosol
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A 3-MONTH SAFETY EVALUATION EXTENSION TO THE 12-WEEK E004-C STUDY IN ASTHMA PATIENTS (A Double Blinded, Placebo-Controlled, Parallel, 3-Month Safety Study in Adolescent and Adult Patients With Asthma)

Resource links provided by NLM:

Further study details as provided by Amphastar Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • Adverse Events [ Time Frame: up to 12 weeks ] [ Designated as safety issue: Yes ]
    Recording of all adverse events experienced during the course of the study

Secondary Outcome Measures:
  • Change in 12 lead ECG including QT/QTc analysis [ Time Frame: Study visit 4, 8 and 12, greater than one hour after last dose ] [ Designated as safety issue: Yes ]
    A 12-lead ECG (routine and QT/QTc) will be measured and recorded, provided that dosing of study drug has been performed greater than 1 hour prior to conducting the measurements.

  • Asthma Exacerbations [ Time Frame: up to 12 weeks ] [ Designated as safety issue: Yes ]
    Review use of resuce inhaler for treatment of asthma exacrbations occuring between doses of study medication.

Enrollment: 208
Study Start Date: November 2011
Study Completion Date: July 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm T
Arm T is the experimental treatment arm consisting of 2 x 125 mcg/inhalations of E004, QID, with 4-6 hr intervals
Drug: Epinephrine inhalation aerosol, HFA
2 inhalations QID, 125 mcg/inhalation
Other Name: Primatene Mist HFA
Drug: epinephrine inhalation aerosol
2 inhalations of 125 mcg QID
Other Name: Primatene Mist HFA
Placebo Comparator: Arm P
Arm P is a placebo comparator consisting of 2× 0 mcg of placebo inhalations, QID, with 4-6 hr intervals
Drug: Placebo
Placebo for epinephrine inhalation aerosol, formulation without epinephrine, 2x 0 mcg placebo inhalations, QID, every 4-6 hours
Active Comparator: Arm A
Arm A is an active comparator, Primatene Mist, consisting of 2× 220 mcg/inhalation, QID, with 4-6 hr intervals
Drug: Primatene Mist
2x 220 mcg Primatene Mist inhalations, QID, 4-6 times a day
Other Name: Primatene Mist


Ages Eligible for Study:   12 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Please refer to this study by its identifier: NCT01476904

  Show 27 Study Locations
Sponsors and Collaborators
Amphastar Pharmaceuticals, Inc.
Study Director: Safety Monitor Amphastar Pharmaceuticals, Inc.
  More Information

Responsible Party: Amphastar Pharmaceuticals, Inc. Identifier: NCT01476904     History of Changes
Other Study ID Numbers: API-E004-CL-C2
Study First Received: November 15, 2011
Last Updated: July 9, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Amphastar Pharmaceuticals, Inc.:
Bronchial Asthma
Shortness of breath

Additional relevant MeSH terms:
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Epinephryl borate
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Adrenergic alpha-Agonists
Vasoconstrictor Agents
Cardiovascular Agents processed this record on April 21, 2014