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AsthmaPhase 3NCT01357642

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

A Phase 3 study testing Epinephrine inhalation aerosol in people with Asthma, run by Amphastar Pharmaceuticals, Inc. at 33 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 12 to 75 years
Conditions the study is for
Asthma
What is being tested?
Epinephrine inhalation aerosol
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
373 participants
Where
33 sitesUnited States
Study dates
Jul 2011to Dec 2011
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 to 75 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

33 sites in 1 country.

33 sites in 1 country

United States33 sites

  • Intergated Medical Research

    Ashland, Oregon, 97520

  • The Asthma & Allergy Center

    Bellevue, Nebraska, 68123

  • Clinical Research Group of Montana

    Bozeman, Montana, 59718

  • Colorado Allergy & Asthma Centers

    Centennial, Colorado, 80112

  • National Allergy, Asthma & Urticaria Centers of Charleston

    Charleston, South Carolina, 29406

  • New Horizons Clinical Research

    Cincinnati, Ohio, 45242

  • West Coast Clinical Trials

    Costa Mesa, California, 92626

  • Colorado Allergy & Asthma Centers

    Denver, Colorado, 80230

  • Western Sky Research

    El Paso, Texas, 79903

  • Allergy and Asthma Research Group

    Eugene, Oregon, 97401

  • Iowa Clinical Research Corporation

    Iowa City, Iowa, 52240

  • Baker Allergy, Asthma & Dermatology Research Center

    Lake Oswego, Oregon, 97035

  • Southern California Institute for Respiratory Diseases

    Los Angeles, California, 90048

  • Family Allergy & Asthma Research Institute

    Louisville, Kentucky, 40215

  • The Clinical Research Institute of Southern Oregon

    Medford, Oregon, 97504

  • Clinical Research Institute

    Minneapolis, Minnesota, 55402

  • Asthma and Allergy Associates of Southern California

    Mission Viejo, California, 92691

  • Central Texas Health Research

    New Braunfels, Texas, 78130

  • Northeast Medical Research Associates

    No. Dartmouth, Massachusetts, 02747

  • CHOC PSF, Division of Allergy, Asthma and Immunology

    Orange, California, 92868

  • Allergy and Clinical Immunology Associates

    Pittsburgh, Pennsylvania, 15241

  • Clinical Research Institute

    Plymouth, Minnesota, 55441

  • Transitional Clinical Research

    Portland, Oregon, 97213

  • North Carolina Clinical Research

    Raleigh, North Carolina, 27607

  • Allergy Partners

    Richmond, Virginia, 23229

  • Sylvana Research Associates

    San Antonio, Texas, 78229

  • Allergy & Asthma Assocaites of Santa Clara Valley

    San Jose, California, 95117

  • ASTHMA, Inc.

    Seattle, Washington, 98105

  • Princeton Center for Clinical Research

    Skillman, New Jersey, 08558

  • The Clinical Research Center

    St Louis, Missouri, 63141

  • Asthma & Allergy Research Associates

    Upland, Pennsylvania, 17013

  • Rocky Mountain Center for Clinical Research

    Wheat Ridge, Colorado, 80033

  • Atlanta Allergy & Asthma Clinic

    Woodstock, Georgia, 30188

Other trials in United States

About this study

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

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.

Conditions
Asthma
Being tested
Epinephrine inhalation aerosol, Placebo
Keywords
asthma, bronchial asthma, shortness of breath
Medical subject headings
Asthma, Dyspnea

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Epinephrine inhalation aerosolDrug

    Also called epinephrine inhalation aerosol - HFA propelled

    Epinephrine inhalation aerosol, 125 mcg/inhalation, 2 inhalations QID at 4 - 6 hour intervals

  • PlaceboDrug

    Placebo for epinephrine inhalation aerosol, formulation without epinephrine

  • epinephrine inhalation aerosolDrug

    Also called Primatene Mist

    epinephrine inhalation aerosol, 220 mcg/inhalation, 2 inhalations QID at 4-6 hour intervals

Study groups in NCT01357642
Study groupRoleWhat they receive
Arm TExperimentalArm T is the experimental treatment arm consisting of 2 x 125 mcg/inhalations of E004, QID, with 4-6 hr intervals
Receives: Drug: Epinephrine inhalation aerosol
Arm PPlacebo comparatorPlacebo comparator as 2×Placebo QID, with 4-6 hr intervals
Receives: Drug: Placebo
Arm AActive comparatorActive comparator, Primatene Mist, 2×220 mcg/inhalation, QID, with 4-6 hr intervals
Receives: Drug: epinephrine inhalation aerosol

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: at 5, 30, 60, 120, 180, 240, and 360 minutes post-dose

Secondary outcomes (3)

  1. Monitor vital signs

    Assess blood pressure, pulse rate

    Measured: 2, 10, 20, 60, and 360 min after dosing

  2. Cardiac rhythm

    At study visits 1 and 5 only, perform 12 lead ECG

    Measured: at baseline, 2, 10, 20, and 60 min post-dose

  3. Blood glucose and potassium

    Monitor blood glucose and potassium levels to assure appropriate balance

    Measured: baseline, and at 15 and 120 min post-dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 May 2011 (estimated)
  2. Study startJul 2011
  3. Primary completionNov 2011
  4. Study completionDec 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
373 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01357642
Sponsor's protocol ID
API-E004-CL-C
Status last verified
Feb 2016
First submitted
19 May 2011
Last updated
11 Mar 2016
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 2019665

  • 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.

    PubMed 16400891

  • 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.

    PubMed 3780129

  • 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.

    PubMed 10919679

  • 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.

    PubMed 10936150

  • 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.

    PubMed 11061773

  • 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.

    PubMed 31959019

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Epinephrine inhalation aerosol in people with Asthma, run by Amphastar Pharmaceuticals, Inc. at 33 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 33 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Area Under the Curve (AUC) versus placebo (time frame: at 5, 30, 60, 120, 180, 240, and 360 minutes post-dose). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01357642, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2016.

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