Clinical trial NCT01476904: Safety Study in Adolescent and Adult Patients With Asthma
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)
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: 2011-11-22
Enrollment: 208
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: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Adverse Events
timeFrame: up to 12 weeks
Secondary outcomes:
measure: Change in 12 lead ECG including QT/QTc analysis
timeFrame: Study visit 4, 8 and 12, greater than one hour after last dose
measure: Asthma Exacerbations
timeFrame: up to 12 weeks
Other outcomes:
Locations:
city: Costa Mesa
country: United States
facility: Amphastar Site 0006
state: California
city: Los Angeles
country: United States
facility: Amphastar Site 0005
state: California
city: Orange
country: United States
facility: Amphastar Site 0004
state: California
city: San Jose
country: United States
facility: Amphastar Site 0001
state: California
city: Stockton
country: United States
facility: Amphastar Site 0003
state: California
city: Denver
country: United States
facility: Amphastar Site 0008
state: Colorado
city: Wheat Ridge
country: United States
facility: Amphastar Site 0009
state: Colorado
city: Iowa City
country: United States
facility: Amphastar Site 0011
state: Iowa
city: North Dartmouth
country: United States
facility: Amphastar Site 0013
state: Massachusetts
city: Minneapolis
country: United States
facility: Amphastar Site 0014
state: Minnesota
city: Plymouth
country: United States
facility: Amphastar Site 0015
state: Minnesota
city: St. Louis
country: United States
facility: Amphastar Site 0016
state: Missouri
city: Bozeman
country: United States
facility: Amphastar Site 0017
state: Montana
city: Bellevue
country: United States
facility: Amphastar Site 0019
state: Nebraska
city: Skillman
country: United States
facility: Amphastar Site 0020
state: New Jersey
city: Raleigh
country: United States
facility: Amphastar Site 0018
state: North Carolina
city: Cincinnati
country: United States
facility: Amphastar Site 0021
state: Ohio
city: Ashland
country: United States
facility: Amphastar Site 0024
state: Oregon
city: Eugene
country: United States
facility: Amphastar Site 0022
state: Oregon
city: Lake Oswego
country: United States
facility: Amphastar Site 0023
state: Oregon
city: Medford
country: United States
facility: Amphastar Site 0025
state: Oregon
city: Portland
country: United States
facility: Amphastar Site 0026
state: Oregon
city: North Charleston
country: United States
facility: Amphastar Site 0029
state: South Carolina
city: El Paso
country: United States
facility: Amphastar Site 0031
state: Texas
city: New Braunfels
country: United States
facility: Amphastar Site 0030
state: Texas
city: Richmond
country: United States
facility: Amphastar Site 0033
state: Virginia
city: Seattle
country: United States
facility: Amphastar Site 0034
state: Washington
Study officials:
affiliation: Amphastar Pharmaceuticals, Inc.
name: Safety Monitor
role: STUDY_DIRECTOR
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: 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: 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: 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.
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.