Clinical trial NCT01357642: Epinephrine Inhalation Aerosol USP: For Evaluation Of Efficacy And Safety In Asthma Patients
Official title: Epinephrine Inhalation Aerosol USP, an HFA-MDI: Clinical Study-C For Evaluation Of Efficacy And Safety In Asthma Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Asthma
Keywords: asthma
bronchial asthma
shortness of breath
Lead sponsor: Amphastar Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2011-05-23
Enrollment: 373
Sex: ALL
Minimum age (years): 12
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in Area Under the Curve (AUC) versus placebo
timeFrame: at 5, 30, 60, 120, 180, 240, and 360 minutes post-dose
Secondary outcomes:
measure: Monitor vital signs
timeFrame: 2, 10, 20, 60, and 360 min after dosing
measure: Cardiac rhythm
timeFrame: at baseline, 2, 10, 20, and 60 min post-dose
measure: Blood glucose and potassium
timeFrame: baseline, and at 15 and 120 min post-dose
Other outcomes:
Locations:
city: Costa Mesa
country: United States
facility: West Coast Clinical Trials
state: California
city: Los Angeles
country: United States
facility: Southern California Institute for Respiratory Diseases
state: California
city: Mission Viejo
country: United States
facility: Asthma and Allergy Associates of Southern California
state: California
city: Orange
country: United States
facility: CHOC PSF, Division of Allergy, Asthma and Immunology
state: California
city: San Jose
country: United States
facility: Allergy & Asthma Assocaites of Santa Clara Valley
state: California
city: Centennial
country: United States
facility: Colorado Allergy & Asthma Centers
state: Colorado
city: Denver
country: United States
facility: Colorado Allergy & Asthma Centers
state: Colorado
city: Wheat Ridge
country: United States
facility: Rocky Mountain Center for Clinical Research
state: Colorado
city: Woodstock
country: United States
facility: Atlanta Allergy & Asthma Clinic
state: Georgia
city: Iowa City
country: United States
facility: Iowa Clinical Research Corporation
state: Iowa
city: Louisville
country: United States
facility: Family Allergy & Asthma Research Institute
state: Kentucky
city: No. Dartmouth
country: United States
facility: Northeast Medical Research Associates
state: Massachusetts
city: Minneapolis
country: United States
facility: Clinical Research Institute
state: Minnesota
city: Plymouth
country: United States
facility: Clinical Research Institute
state: Minnesota
city: St. Louis
country: United States
facility: The Clinical Research Center
state: Missouri
city: Bozeman
country: United States
facility: Clinical Research Group of Montana
state: Montana
city: Bellevue
country: United States
facility: The Asthma & Allergy Center
state: Nebraska
city: Skillman
country: United States
facility: Princeton Center for Clinical Research
state: New Jersey
city: Raleigh
country: United States
facility: North Carolina Clinical Research
state: North Carolina
city: Cincinnati
country: United States
facility: New Horizons Clinical Research
state: Ohio
city: Ashland
country: United States
facility: Intergated Medical Research
state: Oregon
city: Eugene
country: United States
facility: Allergy and Asthma Research Group
state: Oregon
city: Lake Oswego
country: United States
facility: Baker Allergy, Asthma & Dermatology Research Center
state: Oregon
city: Medford
country: United States
facility: The Clinical Research Institute of Southern Oregon
state: Oregon
city: Portland
country: United States
facility: Transitional Clinical Research
state: Oregon
city: Pittsburg
country: United States
facility: Allergy and Clinical Immunology Associates
state: Pennsylvania
city: Upland
country: United States
facility: Asthma & Allergy Research Associates
state: Pennsylvania
city: Charleston
country: United States
facility: National Allergy, Asthma & Urticaria Centers of Charleston
state: South Carolina
city: El Paso
country: United States
facility: Western Sky Research
state: Texas
city: New Braunfels
country: United States
facility: Central Texas Health Research
state: Texas
city: San Antonio
country: United States
facility: Sylvana Research Associates
state: Texas
city: Richmond
country: United States
facility: Allergy Partners
state: Virginia
city: Seattle
country: United States
facility: ASTHMA, Inc.
state: Washington
Study officials:
References:
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. doi: 10.1002/j.1552-4604.1991.tb04969.x.
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. doi: 10.1016/S1081-1206(10)61014-9.
citation: 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.
citation: 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.
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. doi: 10.1378/chest.118.2.522.
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. doi: 10.1542/peds.106.5.1040.
citation: 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.