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

Asthma Clinical Trial

Official title:

Epinephrine Inhalation Aerosol USP, an HFA-MDI: Clinical Study-C For Evaluation Of Efficacy And Safety In Asthma Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01357642
• Other study ID #: API-E004-CL-C
• Status: Completed
• Phase: Phase 3
• First received: May 19, 2011
• Last updated: February 11, 2016
• Start date: July 2011
• Est. completion date: December 2011

Study information

• Verified date: February 2016
• Source: Amphastar Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 373
• Est. completion date: December 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• Epinephrine inhalation aerosol
Epinephrine inhalation aerosol, 125 mcg/inhalation, 2 inhalations QID at 4 - 6 hour intervals
• Placebo
Placebo for epinephrine inhalation aerosol, formulation without epinephrine
• epinephrine inhalation aerosol
epinephrine inhalation aerosol, 220 mcg/inhalation, 2 inhalations QID at 4-6 hour intervals

Locations

Country	Name	City	State
United States	Intergated Medical Research	Ashland	Oregon
United States	The Asthma & Allergy Center	Bellevue	Nebraska
United States	Clinical Research Group of Montana	Bozeman	Montana
United States	Colorado Allergy & Asthma Centers	Centennial	Colorado
United States	National Allergy, Asthma & Urticaria Centers of Charleston	Charleston	South Carolina
United States	New Horizons Clinical Research	Cincinnati	Ohio
United States	West Coast Clinical Trials	Costa Mesa	California
United States	Colorado Allergy & Asthma Centers	Denver	Colorado
United States	Western Sky Research	El Paso	Texas
United States	Allergy and Asthma Research Group	Eugene	Oregon
United States	Iowa Clinical Research Corporation	Iowa City	Iowa
United States	Baker Allergy, Asthma & Dermatology Research Center	Lake Oswego	Oregon
United States	Southern California Institute for Respiratory Diseases	Los Angeles	California
United States	Family Allergy & Asthma Research Institute	Louisville	Kentucky
United States	The Clinical Research Institute of Southern Oregon	Medford	Oregon
United States	Clinical Research Institute	Minneapolis	Minnesota
United States	Asthma and Allergy Associates of Southern California	Mission Viejo	California
United States	Central Texas Health Research	New Braunfels	Texas
United States	Northeast Medical Research Associates	No. Dartmouth	Massachusetts
United States	CHOC PSF, Division of Allergy, Asthma and Immunology	Orange	California
United States	Allergy and Clinical Immunology Associates	Pittsburg	Pennsylvania
United States	Clinical Research Institute	Plymouth	Minnesota
United States	Transitional Clinical Research	Portland	Oregon
United States	North Carolina Clinical Research	Raleigh	North Carolina
United States	Allergy Partners	Richmond	Virginia
United States	Sylvana Research Associates	San Antonio	Texas
United States	Allergy & Asthma Assocaites of Santa Clara Valley	San Jose	California
United States	ASTHMA, Inc.	Seattle	Washington
United States	Princeton Center for Clinical Research	Skillman	New Jersey
United States	The Clinical Research Center	St. Louis	Missouri
United States	Asthma & Allergy Research Associates	Upland	Pennsylvania
United States	Rocky Mountain Center for Clinical Research	Wheat Ridge	Colorado
United States	Atlanta Allergy & Asthma Clinic	Woodstock	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Amphastar Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (6)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Warren JB, Doble N, Dalton N, Ewan PW. Systemic absorption of inhaled epinephrine. Clin Pharmacol Ther. 1986 Dec;40(6):673-8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Area Under the Curve (AUC) versus placebo	Serial FEV1 measurements to demonstrate the mean AUC of change in percent FEV1 from same-day baseline of E004 (Treatment T; Epinephrine-HFA) versus Placebo-HFA (Treatment P) is the primary efficacy endpoint.	at 5, 30, 60, 120, 180, 240, and 360 minutes post-dose	No
Secondary	Monitor vital signs	Assess blood pressure, pulse rate	2, 10, 20, 60, and 360 min after dosing	Yes
Secondary	Cardiac rhythm	At study visits 1 and 5 only, perform 12 lead ECG	at baseline, 2, 10, 20, and 60 min post-dose	Yes
Secondary	Blood glucose and potassium	Monitor blood glucose and potassium levels to assure appropriate balance	baseline, and at 15 and 120 min post-dose	Yes