AsthmaPhase 1/2NCT01188577

Epinephrine Inhalation Aerosol USP, a HFA-MDI Study for Assessment of Pharmacokinetics

A Phase 1/2 study testing Epinephrine Inhalation Aerosol, HFA and Epinephrine Inhalation Aerosol in people with Asthma and Bronchospasm, run by Amphastar Pharmaceuticals, Inc. at 1 site in United States.

Completed

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

Official record

Search all trials

Trial summary

This study examines the pharmacokinetic profile of Armstrong's proposed Epinephrine Inhalation Aerosol USP, an HFA-MDI (E004), using a stable isotope deuterium-labeled epinephrine (epinephrine-d3) to differentiate the administered drug from the endogenous epinephrine, in healthy male and female adult volunteers. Read more about this study

Who is it for?: Ages 18 to 30 yearsHealthy volunteers can take part
Conditions the study is for: Asthma, Bronchospasm, Wheezing
What is being tested?: Epinephrine Inhalation Aerosol, HFA and Epinephrine Inhalation Aerosol
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 23 participants
Where: 1 siteUnited States
Study dates: Aug 2010to Jan 2011
Phase: Phase 1/2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 18 to 30 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Generally healthy at screening;
No clinically significant respiratory, cardiovascular and other systemic or organic illnesses;
Body weight ≥ 50 kg for men and ≥ 45 kg for women,
Sitting blood pressure ≤ 135/90 mm Hg;
Demonstrating negative HIV, HBsAg and HCV-Ab screen tests;
Women of child-bearing potential must be non-pregnant, non-lactating, and practicing a clinically acceptable form of birth control;
Properly consented
Other criteria apply

Who cannot join

A smoking history of ≥10 pack-years, or having smoked within 6 months;
Upper respiratory tract infections within 2 wk, or lower respiratory tract infection within 4 wk, prior to Screening;
Any current or recent respiratory conditions that might significantly affect pharmacodynamic response to the study drugs;
Known intolerance or hypersensitivity to the study MDI ingredients;
Having been on other investigational studies, or donated blood, in the last 30 days;
Other Criteria Apply

Trial locations and contacts

1 site in 1 country.

United States1 site

Amphastar Site 0035
Cypress, California, 90630

Other trials in United States

About this study

Official title: Epinephrine Inhalation Aerosol USP, an HFA-MDI CLINICAL STUDY-B2 FOR ASSESSMENT OF PHARMACOKINETICS (A Randomized, Evaluator-Blind, Single-Dose, Two Arm, Crossover, PK Study in Healthy Volunteers)

Read the detailed description

E004 is formulated with epinephrine free base as the active ingredient, and hydrofluoroalkane (HFA-134a) as the propellant.

In order to differentiate the inhaled epinephrine from the fluctuating background of endogenous epinephrine 1, a stable-isotope deuterium (2H) labeled epinephrine (epinephrine-d3) preparation will be used to formulate E004 inhalers, denoted as E004-d3. PK of E004 at 125 mcg of epinephrine-d3 per inhalation, will be compared to that of the currently marketed, non-labeled, Epinephrine-CFC MDI as the Reference Control (220 mcg per inhalation).

This study is a randomized, evaluator-blind, single dose, two-arm, crossover, PK study, to be conducted in ~18 healthy, male and female, adult volunteers. PK will be studied using E004-d3 at 125 mcg per inhalation (Arm T). A currently marketed, non-labeled, Epinephrine CFC-MDI will be used as a Reference Control (Arm C).

Conditions: Asthma, Bronchospasm, Wheezing, Shortness of Breath
Being tested: Epinephrine Inhalation Aerosol, HFA, Epinephrine Inhalation Aerosol
Keywords: asthma, bronchospasm, wheezing, shortness of breath
Medical subject headings: Asthma, Bronchial Spasm, Respiratory Sounds, Dyspnea

What participants receive

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

Epinephrine Inhalation Aerosol, HFADrug
Also called HFA epinephrine inhalation aerosol, 125 mcg/inhalation
10 inhalations of epinephrine inhalation aerosol, 125 mcg/inhalation
Epinephrine Inhalation AerosolDrug
Also called Primatene Mist, Epinephrine Inhalation Aerosol, USP
Epinephrine Inhalation Aerosol, 220 mcg/ inhalation, 10 inhalations

Study groups in NCT01188577
Study group	Role	What they receive
Epinephrine Inhalation Aerosol, HFA	Experimental	Experimental treatment of 10 inhalations of 125 mcg epinephrine base propelled by HFA 134a Receives: Drug: Epinephrine Inhalation Aerosol, HFA
Epinephrine Inhalation Aerosol, CFC	Active comparator	Epinephrine Inhalation Aerosol, CFC propelled, 220 mcg/inhalation , 10 inhalations Receives: Drug: Epinephrine Inhalation Aerosol

What is being measured

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

Baseline Concentration (C0) of Total Epinephrine
Patient PK blood samples were taken from a vein in a hand or arm via indwelling heparin-anticoagulated IV catheters, or by venipunctures at Baseline (prior to dosing) in each treatment period following a specified washout period (3-14 days), and were analyzed using an established analysis method. Baseline concentration (C0) is the concentration of epinephrine measured in the plasma at this time point.
Measured: 0 to 30 minutes prior to dosing
Peak Concentration (Cmax) of Total Epinephrine From Time Zero to 6 Hours Post-dose
Patient PK blood samples were taken from a vein in a hand or arm via indwelling heparin-anticoagulated IV catheters, or by venipunctures at 0 (baseline), 2, 5, 7.5, 10, 12.5, 15, 20, 25, 30, 45, 60, 90, 120, 240, and 360 minutes post-dose in each treatment period and were analyzed using an established analysis method. Peak (maximum) concentration (Cmax) is the highest concentration of epinephrine measured in plasma during the treatment period.
Measured: Pre-dose to 6 hours post-dose
Area Under the Curve From Time Zero to 6 Hours Post-dose (AUC[0-6]) for Total Epinephrine
Patient PK blood samples were taken from a vein in a hand or arm via indwelling heparin-anticoagulated IV catheters, or by venipunctures at 0 (baseline), 2, 5, 7.5, 10, 12.5, 15, 20, 25, 30, 45, 60, 90, 120, 240, and 360 minutes post-dose in each treatment period and were analyzed using an established analysis method. Area under the curve from time zero to 6 hours post-dose (AUC[0-6]) was calculated using the trapezoidal rule.
Measured: Pre-dose to 6 hours post-dose
Time to Reach Peak Concentration (Tmax) for Total Epinephrine
Patient PK blood samples were taken from a vein in a hand or arm via indwelling heparin-anticoagulated IV catheters, or by venipunctures at 0 (baseline), 2, 5, 7.5, 10, 12.5, 15, 20, 25, 30, 45, 60, 90, 120, 240, and 360 minutes post-dose in each treatment period and were analyzed using an established analysis method. Tmax is the amount of time it takes for epinephrine to reach peak concentration in plasma during the treatment period.
Measured: Pre-dose to 6 hours post-dose
Half-life (t1/2) of Total Epinephrine
Patient PK blood samples were taken from a vein in a hand or arm via indwelling heparin-anticoagulated IV catheters, or by venipunctures at 0 (baseline), 2, 5, 7.5, 10, 12.5, 15, 20, 25, 30, 45, 60, 90, 120, 240, and 360 minutes post-dose in each treatment period and were analyzed using an established analysis method. Half-life (t1/2) is the amount of time it takes for epinephrine to decrease to half the peak concentration in plasma during the treatment period.
Measured: Pre-dose to 6 hours post-dose
Concentration vs. Time for Total Epinephrine From Time Zero to 6 Hours Post-dose
Patient PK blood samples were taken from a vein in a hand or arm via indwelling heparin-anticoagulated IV catheters, or by venipunctures at 0 (baseline), 2, 5, 7.5, 10, 12.5, 15, 20, 25, 30, 45, 60, 90, 120, 240, and 360 minutes post-dose in each treatment period and were analyzed using an established analysis method.
Measured: Pre-dose to 6 hours post-dose

Timeline

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

Aug 2010Jan 2011

First posted25 Aug 2010 (estimated)
Study startAug 2010
Primary completionSep 2010
Study completionJan 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (9)Papers the sponsor has linked to this study.
Other trials for AsthmaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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 1/2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Triple blind
Who is masked: Participant, Care provider, Outcomes assessor
Enrolment: 23 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01188577
Sponsor's protocol ID: API-E004-CL-B2
Status last verified: Jun 2017
First submitted: 24 Aug 2010
Last updated: 25 Jul 2017
Results posted: Yes, on ClinicalTrials.gov
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
Kushner DJ, Baker A, Dunstall TG. Pharmacological uses and perspectives of heavy water and deuterated compounds. Can J Physiol Pharmacol. 1999 Feb;77(2):79-88.
PubMed 10535697
Bondesson E, Friberg K, Soliman S, Lofdahl CG. Safety and efficacy of a high cumulative dose of salbutamol inhaled via Turbuhaler or via a pressurized metered-dose inhaler in patients with asthma. Respir Med. 1998 Feb;92(2):325-30. doi: 10.1016/s0954-6111(98)90116-0.
PubMed 9616533
Kerwin EM, Marrs T, Luo MZ, Zhang JY. Pharmacokinetic Study of Epinephrine Hydrofluoroalkane (Primatene MIST) Metered-Dose Inhaler. J Aerosol Med Pulm Drug Deliv. 2020 Oct;33(5):282-287. doi: 10.1089/jamp.2019.1577. Epub 2020 May 18.
PubMed 32423275

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 25 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Epinephrine Inhalation Aerosol USP, an HFA-MDI CLINICAL STUDY-B2 FOR ASSESSMENT OF PHARMACOKINETICS (A Randomized, Evaluator-Blind, Single-Dose, Two Arm, Crossover, PK Study in Healthy Volunteers)
ClinicalTrials.gov ID: NCT01188577
Acronym / sponsor ID: API-E004-CL-B2
Conditions: Asthma, Bronchospasm, Wheezing, Shortness of Breath
Keywords: asthma, bronchospasm, wheezing, shortness of breath
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 23 participants (actual)
Lead sponsor: Amphastar Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
Study start: Aug 2010
Primary completion: Sep 2010 (actual)
Study completion: Jan 2011 (actual)
First posted: 25 Aug 2010 (estimated)
Results: Posted 24 Oct 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

E004 is formulated with epinephrine free base as the active ingredient, and hydrofluoroalkane (HFA-134a) as the propellant.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Triple blind (participant, care provider, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Epinephrine Inhalation Aerosol, HFA	Experimental	Drug: Epinephrine Inhalation Aerosol, HFAExperimental treatment of 10 inhalations of 125 mcg epinephrine base propelled by HFA 134a
Epinephrine Inhalation Aerosol, CFC	Active comparator	Drug: Epinephrine Inhalation AerosolEpinephrine Inhalation Aerosol, CFC propelled, 220 mcg/inhalation , 10 inhalations

Who may qualify

Ages: 18 to 30 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (8 listed)

Generally healthy at screening;
No clinically significant respiratory, cardiovascular and other systemic or organic illnesses;
Body weight ≥ 50 kg for men and ≥ 45 kg for women,
Sitting blood pressure ≤ 135/90 mm Hg;
Demonstrating negative HIV, HBsAg and HCV-Ab screen tests;

Key exclusion criteria (6 listed)

A smoking history of ≥10 pack-years, or having smoked within 6 months;
Upper respiratory tract infections within 2 wk, or lower respiratory tract infection within 4 wk, prior to Screening;
Any current or recent respiratory conditions that might significantly affect pharmacodynamic response to the study drugs;
Known intolerance or hypersensitivity to the study MDI ingredients;
Having been on other investigational studies, or donated blood, in the last 30 days;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Epinephrine Inhalation Aerosol, HFAAlso: HFA epinephrine inhalation aerosol, 125 mcg/inhalation10 inhalations of epinephrine inhalation aerosol, 125 mcg/inhalation	Drug	Epinephrine Inhalation Aerosol, HFA
Epinephrine Inhalation AerosolAlso: Primatene Mist, Epinephrine Inhalation Aerosol, USPEpinephrine Inhalation Aerosol, 220 mcg/ inhalation, 10 inhalations	Drug	Epinephrine Inhalation Aerosol, CFC

Primary outcome

Baseline Concentration (C0) of Total Epinephrine
Time frame: 0 to 30 minutes prior to dosing
Patient PK blood samples were taken from a vein in a hand or arm via indwelling heparin-anticoagulated IV catheters, or by venipunctures at Baseline (prior to dosing) in each treatment period following a specified washout period (3-14 days), and were analyzed using an established analysis method. Baseline concentration (C0) is the concentration of epinephrine measured in the plasma at this time point.
Peak Concentration (Cmax) of Total Epinephrine From Time Zero to 6 Hours Post-dose
Time frame: Pre-dose to 6 hours post-dose
Patient PK blood samples were taken from a vein in a hand or arm via indwelling heparin-anticoagulated IV catheters, or by venipunctures at 0 (baseline), 2, 5, 7.5, 10, 12.5, 15, 20, 25, 30, 45, 60, 90, 120, 240, and 360 minutes post-dose in each treatment period and were analyzed using an established analysis method. Peak (maximum) concentration (Cmax) is the highest concentration of epinephrine measured in plasma during the treatment period.
Area Under the Curve From Time Zero to 6 Hours Post-dose (AUC[0-6]) for Total Epinephrine
Time frame: Pre-dose to 6 hours post-dose
Patient PK blood samples were taken from a vein in a hand or arm via indwelling heparin-anticoagulated IV catheters, or by venipunctures at 0 (baseline), 2, 5, 7.5, 10, 12.5, 15, 20, 25, 30, 45, 60, 90, 120, 240, and 360 minutes post-dose in each treatment period and were analyzed using an established analysis method. Area under the curve from time zero to 6 hours post-dose (AUC[0-6]) was calculated using the trapezoidal rule.
Time to Reach Peak Concentration (Tmax) for Total Epinephrine
Time frame: Pre-dose to 6 hours post-dose
Patient PK blood samples were taken from a vein in a hand or arm via indwelling heparin-anticoagulated IV catheters, or by venipunctures at 0 (baseline), 2, 5, 7.5, 10, 12.5, 15, 20, 25, 30, 45, 60, 90, 120, 240, and 360 minutes post-dose in each treatment period and were analyzed using an established analysis method. Tmax is the amount of time it takes for epinephrine to reach peak concentration in plasma during the treatment period.
Half-life (t1/2) of Total Epinephrine
Time frame: Pre-dose to 6 hours post-dose
Patient PK blood samples were taken from a vein in a hand or arm via indwelling heparin-anticoagulated IV catheters, or by venipunctures at 0 (baseline), 2, 5, 7.5, 10, 12.5, 15, 20, 25, 30, 45, 60, 90, 120, 240, and 360 minutes post-dose in each treatment period and were analyzed using an established analysis method. Half-life (t1/2) is the amount of time it takes for epinephrine to decrease to half the peak concentration in plasma during the treatment period.
Concentration vs. Time for Total Epinephrine From Time Zero to 6 Hours Post-dose
Time frame: Pre-dose to 6 hours post-dose
Patient PK blood samples were taken from a vein in a hand or arm via indwelling heparin-anticoagulated IV catheters, or by venipunctures at 0 (baseline), 2, 5, 7.5, 10, 12.5, 15, 20, 25, 30, 45, 60, 90, 120, 240, and 360 minutes post-dose in each treatment period and were analyzed using an established analysis method.

Results and safety

Results posted to the registry on 24 Oct 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
C, T	11	11
T, C	12	12

Primary outcome: Baseline Concentration (C0) of Total Epinephrine

Time frame: 0 to 30 minutes prior to dosing. Mean (Standard Deviation). Unit: pg/mL

Measure	Treatment T n = 23	Treatment C n = 23
Value	2.6 (8.7)	4.3 (16.7)

Population analysed: Patients who: 1) have taken the valid pre-dose baseline PK sample 2) have correctly taken the randomized study drug treatment 3) have at least three of the four post-dose PK measurement btwn 2 and 10 min post-dose available and 4) have a minimum of twelve of the fifteen post-dose PK measurements for the entire 6 hour post-dose PK sampling period.

Primary outcome: Peak Concentration (Cmax) of Total Epinephrine From Time Zero to 6 Hours Post-dose

Time frame: Pre-dose to 6 hours post-dose. Mean (Standard Deviation). Unit: pg/mL

Measure	Treatment T n = 23	Treatment C n = 23
Value	862 (527)	190 (119)

Population analysed: Patients who: 1) have taken the valid pre-dose baseline PK sample 2) have correctly taken the randomized study drug treatment 3) have at least three of the four post-dose PK measurements btw 2 and 10 min post-dose available and 4) have a minimum of twelve of the fifteen post-dose PK measurements for the entire 6 hour post-dose PK sampling period.

Primary outcome: Area Under the Curve From Time Zero to 6 Hours Post-dose (AUC[0-6]) for Total Epinephrine

Time frame: Pre-dose to 6 hours post-dose. Mean (Standard Deviation). Unit: pg*min/mL

Measure	Treatment T n = 23	Treatment C n = 23
Value	8498 (5213)	6191 (4108)

Population analysed: Patients who: 1) have taken the valid pre-dose baseline PK sample 2) have correctly taken the randomized study drug treatment 3) have at least three of the four post-dose PK measurements btw 2 and 10 min post-dose available and 4) have a minimum of twelve of the fifteen post-dose PK measurements for the entire 6 hour post-dose PK sampling period.

Primary outcome: Time to Reach Peak Concentration (Tmax) for Total Epinephrine

Time frame: Pre-dose to 6 hours post-dose. Mean (Standard Deviation). Unit: min

Measure	Treatment T n = 23	Treatment C n = 23
Value	2.3 (1.7)	3.4 (4.3)

Population analysed: Patients who: 1) have taken the valid pre-dose baseline PK sample 2) have correctly taken the randomized study drug treatment 3) have at least three of the four post-dose PK measurements btw 2 and 10 min post-dose available and 4) have a minimum of twelve of the fifteen post-dose PK measurements for the entire 6 hour post-dose PK sampling period.

Adverse events

Time frame: Throughout entire study period. Other adverse events reported at 3% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Treatment T	0 of 23 (0%)	1 of 23 (4.3%)	Not reported
Treatment C	0 of 23 (0%)	2 of 23 (8.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 2019665Pinnas 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.
Background: PubMed 16400891Hendeles 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.
Background: PubMed 3780129Warren 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.
Background: PubMed 10919679Cripps 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.
Background: PubMed 10936150Dickinson 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.
Background: PubMed 11061773Simons 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.
Background: PubMed 10535697Kushner DJ, Baker A, Dunstall TG. Pharmacological uses and perspectives of heavy water and deuterated compounds. Can J Physiol Pharmacol. 1999 Feb;77(2):79-88.
Background: PubMed 9616533Bondesson E, Friberg K, Soliman S, Lofdahl CG. Safety and efficacy of a high cumulative dose of salbutamol inhaled via Turbuhaler or via a pressurized metered-dose inhaler in patients with asthma. Respir Med. 1998 Feb;92(2):325-30. doi: 10.1016/s0954-6111(98)90116-0.
Derived from this study: PubMed 32423275Kerwin EM, Marrs T, Luo MZ, Zhang JY. Pharmacokinetic Study of Epinephrine Hydrofluoroalkane (Primatene MIST) Metered-Dose Inhaler. J Aerosol Med Pulm Drug Deliv. 2020 Oct;33(5):282-287. doi: 10.1089/jamp.2019.1577. Epub 2020 May 18.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Medical Director study director

Amphastar Pharmaceuticals, Inc.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 8 inclusion and 6 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 25 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Oct 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Baseline Concentration (C0) of Total Epinephrine (time frame: 0 to 30 minutes prior to dosing). The study lists 6 primary outcomes in all. 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 NCT01188577, which also lists 9 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 25 Jul 2017.