A Phase 1/2 interventional study of Epinephrine Inhalation Aerosol, HFA and Epinephrine Inhalation Aerosol in Asthma, Bronchospasm and Wheezing, sponsored by Amphastar Pharmaceuticals, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years to 30 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-07-25.
Sponsored by Amphastar Pharmaceuticals, Inc. · Phase 1/2, Interventional, and Treatment
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. The current study is designed for a more thorough evaluation of the E004 Pharmacokinetics. Safety of E004 will also be evaluated, under augmented dose conditions.
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).
4,841 studies on the registry are indexed under Asthma; 600 are open to participants now.
This study's enrollment of 23 is below the median of 78 across 3,341 interventional studies indexed under Asthma.
Browse Asthma studies →Amphastar Pharmaceuticals, Inc. is the lead sponsor of 21 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Experimental treatment of 10 inhalations of 125 mcg epinephrine base propelled by HFA 134a
Drug: Epinephrine Inhalation Aerosol, HFA
Epinephrine Inhalation Aerosol, CFC propelled, 220 mcg/inhalation , 10 inhalations
Drug: Epinephrine Inhalation Aerosol
10 inhalations of epinephrine inhalation aerosol, 125 mcg/inhalation
Also known as: HFA epinephrine inhalation aerosol, 125 mcg/inhalation
Epinephrine Inhalation Aerosol, 220 mcg/ inhalation, 10 inhalations
Also known as: Primatene Mist, Epinephrine Inhalation Aerosol, USP
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Pre-dose to 6 hours post-dose
Participants were recruited from a specialty clinic in Cypress, CA between 08/19/2010 and 09/09/2010.
| Milestone | C, T | T, C |
|---|---|---|
| Started | 11 | 12 |
| Completed | 11 | 12 |
| Not completed | 0 | 0 |
| Milestone | C, T | T, C |
|---|---|---|
| Started | 11 | 12 |
| Completed | 11 | 12 |
| Not completed | 0 | 0 |
| Milestone | C, T | T, C |
|---|---|---|
| Started | 11 | 12 |
| Completed | 11 | 12 |
| Not completed | 0 | 0 |
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.
| pg/mL | Treatment T | Treatment C |
|---|---|---|
| Baseline Concentration (C0) of Total Epinephrine | 2.6 ± 8.7 | 4.3 ± 16.7 |
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.
| pg/mL | Treatment T | Treatment C |
|---|---|---|
| Peak Concentration (Cmax) of Total Epinephrine From Time Zero to 6 Hours Post-dose | 862 ± 527 | 190 ± 119 |
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.
| pg*min/mL | Treatment T | Treatment C |
|---|---|---|
| Area Under the Curve From Time Zero to 6 Hours Post-dose (AUC[0-6]) for Total Epinephrine | 8498 ± 5213 | 6191 ± 4108 |
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.
| min | Treatment T | Treatment C |
|---|---|---|
| Time to Reach Peak Concentration (Tmax) for Total Epinephrine | 2.3 ± 1.7 | 3.4 ± 4.3 |
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.
| min | Treatment T | Treatment C |
|---|---|---|
| Half-life (t1/2) of Total Epinephrine | 145.9 (1.7 to 864.0) | 289.8 (1.8 to 1996.3) |
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.
| pg/mL | Treatment T | Treatment C |
|---|---|---|
| 0 min (Baseline) | 2.6 ± 8.7 | 4.3 ± 16.7 |
| 2 min post-dose | 861.5 ± 528.2 | 189.0 ± 123.3 |
| 5 min post-dose | 379.4 ± 203.0 | 99.1 ± 67.0 |
| 7.5 min post-dose | 186.6 ± 97.7 | 48.8 ± 30.0 |
| 10 min post-dose | 118.3 ± 65.8 | 39.7 ± 22.9 |
| 12.5 min post-dose | 75.6 ± 42.2 | 33.9 ± 21.4 |
| 15 min post-dose | 46.8 ± 41.7 | 32.0 ± 23.3 |
| 20 min post-dose | 22.9 ± 21.3 | 30.1 ± 19.8 |
| 25 min post-dose | 10.9 ± 19.9 | 20.3 ± 17.9 |
| 30 min post-dose | 10.5 ± 16.1 | 17.7 ± 19.4 |
| 45 min post-dose | 10.5 ± 22.5 | 19.8 ± 21.2 |
| 60 min post-dose | 8.7 ± 13.9 | 13.2 ± 14.5 |
| 90 min post-dose | 3.5 ± 9.4 | 11.2 ± 18.2 |
| 120 min post-dose | 6.5 ± 13.2 | 6.9 ± 12.0 |
| 240 min post-dose | 16.1 ± 23.8 | 17.7 ± 17.6 |
| 360 min post-dose | 17.1 ± 23.9 | 17.2 ± 20.4 |
Collected over Throughout entire study period. Non-serious events are listed at a 3% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Treatment T | — | 0/23 (0%) | 1/23 (4.3%) |
| Treatment C | — | 0/23 (0%) | 2/23 (8.7%) |
| Event | Treatment T | Treatment C |
|---|---|---|
| DiarrhoeaGastrointestinal disorders | 1/23 | 0/23 |
| CoughRespiratory, thoracic and mediastinal disorders | 0/23 | 1/23 |
| Viral Upper Respiratory Tract InfectionRespiratory, thoracic and mediastinal disorders | 0/23 | 1/23 |
| Age, Continuous(Years) | C, T | T, C | Total |
|---|---|---|---|
| Mean | 22.8 ± 2.99 | 24.8 ± 2.93 | 23.8 ± 3.05 |
| Age, Categorical(Participants) | C, T | T, C | Total |
|---|---|---|---|
| <=18 years | 1 | 0 | 1 |
| Between 18 and 65 years | 10 | 12 | 22 |
| >=65 years | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | C, T | T, C | Total |
|---|---|---|---|
| Female | 2 | 4 | 6 |
| Male | 9 | 8 | 17 |
| Region of Enrollment(participants) | C, T | T, C | Total |
|---|---|---|---|
| United States | 11 | 12 | 23 |
This study is completed, as verified in Jun 2017. You cannot join it, but the record below documents what was studied.
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Amphastar Pharmaceuticals, Inc.