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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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Hypersensitivity, Immediate
Immune System Diseases
Lung Diseases
Lung Diseases, Obstructive
Respiratory Hypersensitivity
Respiratory Tract Diseases
Epinephryl borate
Adrenergic Agents
Adrenergic Agonists
Adrenergic alpha-Agonists
Adrenergic beta-Agonists
Anti-Asthmatic Agents
Autonomic Agents
Bronchodilator Agents
Cardiovascular Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Respiratory System Agents
Therapeutic Uses
Vasoconstrictor Agents processed this record on November 25, 2014