Safety Study in Adolescent and Adult Patients With Asthma

NCT01476904 | Completed Phase 3

• 1 other identifier: API-E004-CL-C2
• Study Type: interventional
• Target: 208
• Locations: 1 country
• Sites: 27

Brief Summary

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.

Conditions

Asthma

Keywords

Asthma; Bronchial Asthma; Shortness of breath

Outcome Measures

Primary Outcomes (1)

• Adverse Events

  Recording of all adverse events experienced during the course of the study

  up to 12 weeks

Secondary Outcomes (2)

• Change in 12 lead ECG including QT/QTc analysis

  Study visit 4, 8 and 12, greater than one hour after last dose

• Asthma Exacerbations

  up to 12 weeks

Study Arms (3)

Arm T

EXPERIMENTAL

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

Drug: Epinephrine inhalation

Arm P

PLACEBO COMPARATOR

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

Drug: Placebo

Arm A

ACTIVE COMPARATOR

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

Drug: Primatene Mist

Interventions

Placebo DRUG

0 mcg/inhalation, 2 inhalations QID

Arm P

Primatene Mist DRUG

220 mcg/inhalation, 2 inhalations QID

Arm A

Epinephrine inhalation DRUG

125 mcg/inhalation, 2 inhalations QID

Arm T

Eligibility Criteria

• Age: 12 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Amphastar Pharmaceuticals, Inc.: lead

Study Sites (27)

Amphastar Site 0006

Costa Mesa, California, 92626, United States

Location

Amphastar Site 0005

Los Angeles, California, 90048, United States

Location

Amphastar Site 0004

Orange, California, 92868, United States

Location

Amphastar Site 0001

San Jose, California, 95117, United States

Location

Amphastar Site 0003

Stockton, California, 95207, United States

Location

Amphastar Site 0008

Denver, Colorado, 80230, United States

Location

Amphastar Site 0009

Wheat Ridge, Colorado, 80033, United States

Location

Amphastar Site 0011

Iowa City, Iowa, 52240, United States

Location

Amphastar Site 0013

North Dartmouth, Massachusetts, 02747, United States

Location

Amphastar Site 0014

Minneapolis, Minnesota, 55402, United States

Location

Amphastar Site 0015

Plymouth, Minnesota, 55441, United States

Location

Amphastar Site 0016

St Louis, Missouri, 63141, United States

Location

Amphastar Site 0017

Bozeman, Montana, 59718, United States

Location

Amphastar Site 0019

Bellevue, Nebraska, 68123, United States

Location

Amphastar Site 0020

Skillman, New Jersey, 08558, United States

Location

Amphastar Site 0018

Raleigh, North Carolina, 27607, United States

Location

Amphastar Site 0021

Cincinnati, Ohio, 45242, United States

Location

Amphastar Site 0024

Ashland, Oregon, 97520, United States

Location

Amphastar Site 0022

Eugene, Oregon, 97401, United States

Location

Amphastar Site 0023

Lake Oswego, Oregon, 97035, United States

Location

Amphastar Site 0025

Medford, Oregon, 97504, United States

Location

Amphastar Site 0026

Portland, Oregon, 97202, United States

Location

Amphastar Site 0029

North Charleston, South Carolina, 29406, United States

Location

Amphastar Site 0031

El Paso, Texas, 79903, United States

Location

Amphastar Site 0030

New Braunfels, Texas, 78130, United States

Location

Amphastar Site 0033

Richmond, Virginia, 23229, United States

Location

Amphastar Site 0034

Seattle, Washington, 98105, United States

Location

Related Publications (8)

• Pinnas JL, Schachtel BP, Chen TM, Roseberry HR, Thoden WR. Inhaled epinephrine and oral theophylline-ephedrine in the treatment of asthma. J Clin Pharmacol. 1991 Mar;31(3):243-7. doi: 10.1002/j.1552-4604.1991.tb04969.x.

  PMID: 2019665 BACKGROUND

• Hendeles L, Marshik PL, Ahrens R, Kifle Y, Shuster J. Response to nonprescription epinephrine inhaler during nocturnal asthma. Ann Allergy Asthma Immunol. 2005 Dec;95(6):530-4. doi: 10.1016/S1081-1206(10)61014-9.

  PMID: 16400891 BACKGROUND

• Warren JB, Doble N, Dalton N, Ewan PW. Systemic absorption of inhaled epinephrine. Clin Pharmacol Ther. 1986 Dec;40(6):673-8. doi: 10.1038/clpt.1986.243.

  PMID: 3780129 BACKGROUND

• Cripps A, Riebe M, Schulze M, Woodhouse R. Pharmaceutical transition to non-CFC pressurized metered dose inhalers. Respir Med. 2000 Jun;94 Suppl B:S3-9.

  PMID: 10919679 BACKGROUND

• Simons FE, Gu X, Johnston LM, Simons KJ. Can epinephrine inhalations be substituted for epinephrine injection in children at risk for systemic anaphylaxis? Pediatrics. 2000 Nov;106(5):1040-4. doi: 10.1542/peds.106.5.1040.

  PMID: 11061773 BACKGROUND

• Dickinson BD, Altman RD, Deitchman SD, Champion HC. Safety of over-the-counter inhalers for asthma: report of the council on scientific affairs. Chest. 2000 Aug;118(2):522-6. doi: 10.1378/chest.118.2.522.

  PMID: 10936150 BACKGROUND

• Hankinson JL, Odencrantz JR, Fedan KB. Spirometric reference values from a sample of the general U.S. population. Am J Respir Crit Care Med. 1999 Jan;159(1):179-87. doi: 10.1164/ajrccm.159.1.9712108.

  PMID: 9872837 BACKGROUND

• Kerwin EM, Tashkin DP, Korenblat PE, Greos LS, Pearlman DS, Bensch GW, Miller SD, Marrs T, Luo MZ, Zhang JY. Long-term safety and efficacy studies of epinephrine HFA metered-dose inhaler (Primatene(R) Mist): a two-stage randomized controlled trial. J Asthma. 2021 May;58(5):633-644. doi: 10.1080/02770903.2020.1713147. Epub 2020 Jan 20.

  PMID: 31959019 DERIVED

MeSH Terms

Conditions

Asthma; Dyspnea

Interventions

Epinephrine

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Safety Monitor

  Amphastar Pharmaceuticals, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2011
• First Posted: November 22, 2011
• Study Start: November 1, 2011
• Primary Completion: April 1, 2012
• Study Completion: July 1, 2012
• Last Updated: February 13, 2017

Record last verified: 2017-02

Locations

US (27)