Safety Study in Adolescent and Adult Patients With Asthma
NCT ID: NCT01476904
Last Updated: 2017-02-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
208 participants
INTERVENTIONAL
2011-11-30
2012-07-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Epinephrine Inhalation Aerosol USP: For Evaluation Of Efficacy And Safety In Asthma Patients
NCT01357642
Evaluation of Efficacy and Safety of E004 in Children With Asthma
NCT01460511
Epinephrine Inhalation Aerosol USP, CLINICAL STUDY-B3 FOR ASSESSMENT OF PHARMACOKINETICS
NCT01255709
Randomized, Placebo/Active Crossover Dose-ranging Study for Safety and Efficacy in Asthma Patients.
NCT01025648
Study of Drug Exposure in Systemic Circulation of Primatene Mist by Oral Inhalation, Versus Epinephrine Injection by Intramuscular Injection and ProAir by Oral Inhalation in Healthy Individuals
NCT04207840
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Arm T
Arm T is the experimental treatment arm consisting of 2 x 125 mcg/inhalations of epinephrine inhalation, QID, with 4-6 hr intervals
Epinephrine inhalation
125 mcg/inhalation, 2 inhalations QID
Arm P
Arm P is a placebo comparator consisting of 2× 0 mcg of placebo inhalations, QID, with 4-6 hr intervals
Placebo
0 mcg/inhalation, 2 inhalations QID
Arm A
Arm A is an active comparator, Primatene Mist, consisting of 2× 220 mcg/inhalation, QID, with 4-6 hr intervals
Primatene Mist
220 mcg/inhalation, 2 inhalations QID
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Placebo
0 mcg/inhalation, 2 inhalations QID
Primatene Mist
220 mcg/inhalation, 2 inhalations QID
Epinephrine inhalation
125 mcg/inhalation, 2 inhalations QID
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
12 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Amphastar Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Safety Monitor
Role: STUDY_DIRECTOR
Amphastar Pharmaceuticals, Inc.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Amphastar Site 0006
Costa Mesa, California, United States
Amphastar Site 0005
Los Angeles, California, United States
Amphastar Site 0004
Orange, California, United States
Amphastar Site 0001
San Jose, California, United States
Amphastar Site 0003
Stockton, California, United States
Amphastar Site 0008
Denver, Colorado, United States
Amphastar Site 0009
Wheat Ridge, Colorado, United States
Amphastar Site 0011
Iowa City, Iowa, United States
Amphastar Site 0013
North Dartmouth, Massachusetts, United States
Amphastar Site 0014
Minneapolis, Minnesota, United States
Amphastar Site 0015
Plymouth, Minnesota, United States
Amphastar Site 0016
St Louis, Missouri, United States
Amphastar Site 0017
Bozeman, Montana, United States
Amphastar Site 0019
Bellevue, Nebraska, United States
Amphastar Site 0020
Skillman, New Jersey, United States
Amphastar Site 0018
Raleigh, North Carolina, United States
Amphastar Site 0021
Cincinnati, Ohio, United States
Amphastar Site 0024
Ashland, Oregon, United States
Amphastar Site 0022
Eugene, Oregon, United States
Amphastar Site 0023
Lake Oswego, Oregon, United States
Amphastar Site 0025
Medford, Oregon, United States
Amphastar Site 0026
Portland, Oregon, United States
Amphastar Site 0029
North Charleston, South Carolina, United States
Amphastar Site 0031
El Paso, Texas, United States
Amphastar Site 0030
New Braunfels, Texas, United States
Amphastar Site 0033
Richmond, Virginia, United States
Amphastar Site 0034
Seattle, Washington, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
API-E004-CL-C2
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.