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AsthmaPhase 2NCT01255709

Epinephrine Inhalation Aerosol USP, CLINICAL STUDY-B3 FOR ASSESSMENT OF PHARMACOKINETICS

A Phase 2 study testing Arm T1: Primatene Mist HFA, Arm T2: Primatene Mist HFA and Arm C: Primatene Mist (epinephrine inhalation aerosol, USP) in people with Asthma, 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
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Trial summary

This study examines the pharmacokinetic profile of Armstrong's proposed Epinephrine Inhalation Aerosol USP, an HFA134a propelled Metered Dose Inhaler (MDI) (E004), using a stable isotope deuterium-labeled epinephrine (epinephrine-d3) to differentiate the administered drug from the endogenous epinephrine, in healthy… Read more about this study

Who is it for?
Ages 18 to 30 yearsHealthy volunteers can take part
Conditions the study is for
Asthma
What is being tested?
Arm T1: Primatene Mist HFA, Arm T2: Primatene Mist HFA and Arm C: Primatene Mist (epinephrine inhalation aerosol, USP)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
1 siteUnited States
Study dates
Dec 2010to Jan 2011
Phase
Phase 2
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 18 to 30 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Generally healthy at screening;
  • Body weight ≥ 50 kg for men and ≥ 45 kg for women;
  • Sitting blood pressure ≤ 135/90 mmHg;
  • Demonstrating negative hIV, HBsAG and DCV-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 prior to Screening;
  • 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 drug/device studies, or donated blood, in the last 30 days prior to Screening;
  • Other criteria apply

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Amphastar Study Site 1

    Cypress, California, 90630

Other trials in United States

About this study

Official title: CLINICAL STUDY-B3 FOR ASSESSMENT OF PHARMACOKINETICS, A Randomized, Evaluator-Blind, Single-Dose, Three Arm, Crossover,PK Study in Healthy Volunteers

This study examines the pharmacokinetic profile of Armstrong's proposed Epinephrine Inhalation Aerosol USP, an HFA134a propelled Metered Dose Inhaler (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 the detailed description

The current study is designed to complement and expand the previous PK studies, API-E004-CL-B and API-E004-CL-B2, with emphasis on lower E004 dose strengths (at 90 and 100 mcg per inhalation), for a more thorough evaluation of the E004 PK profiles. Safety of E004 will also be evaluated, under augmented dose conditions.

Conditions
Asthma
Being tested
Arm T1: Primatene Mist HFA, Arm T2: Primatene Mist HFA, Arm C: Primatene Mist (epinephrine inhalation aerosol, USP)
Keywords
Asthma, shortness of breath, wheezing
Medical subject headings
Asthma, Dyspnea, Respiratory Sounds

What participants receive

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

  • Arm T1: Primatene Mist HFADrug

    Also called epinephrine inhalation aerosol

    epinephrine inhalation aerosol, 90 mcg/inhalation, 12 inhalations over 6 minutes

  • Arm T2: Primatene Mist HFADrug

    Also called epinephrine inhalation aerosol

    epinephrine inhalation aerosol, 100 mcg/inhalation, 12 inhalations over 6 minutes

  • Arm C: Primatene Mist (epinephrine inhalation aerosol, USP)Drug

    Also called epinephrine inhalation aerosol

    epinephrine inhalation aerosol, 220 mcg/inhalation, 12 inhalations over 6 minutes

Study groups in NCT01255709
Study groupRoleWhat they receive
Arm T1 Primatene Mist HFAExperimentalepinephrine inhalation aerosol, 90 mcg/inhalation, 12 inhalations over 6 minutes
Receives: Drug: Arm T1: Primatene Mist HFA
Arm C Primatene MistActive comparatorepinephrine inhalation aerosol, 220 mcg/inhalation, 12 inhalations over 6 minutes
Receives: Drug: Arm C: Primatene Mist (epinephrine inhalation aerosol, USP)
Arm T2 Primatene Mist HFAExperimentalepinephrine inhalation aerosol, 100 mcg/inhalation, 12 inhalations over 6 minutes
Receives: Drug: Arm T2: Primatene Mist HFA

What is being measured

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

  1. Pharmacokinetics including maximum concentration and area under the curve

    Samples will be analyzed with an established LC/MS/MS method, with a quantitative detection limit of 0.02 ng/mL, for both epinephrine-d3 and epinephrine-h3.

    • Mean Maximum concentration of epinephrine (Cmax for epinephrine)
    • Mean Area Under the Curve (AUC) for epinephrine
    • Time to maximum concentration (tmax) and Half life of the drug (t1/2)
    • Epinephrine concentrations versus time

    Measured: -30, 2, 5, 7.5, 10, 12.5, 15, 20, 25, 30, 45, 60, 90, 120, 240 and 360 min postdose.

Secondary outcomes (3)

  1. Vital Signs

    Systolic and Diastolic Blood pressure and heart rate

    Measured: within 30 min predose, at 30, 60 and 360 min postdose

  2. 12-lead Electrocardiogram (ECG)

    12 lead ECG (Routine and QT/QTc intervals)

    Measured: within 30 min pre-dose, and at 15 and 120 min post-dose

  3. Telemetry ECG

    Telemetry recording of heart rate

    Measured: within 30 min pre-dose, and during the initial 5 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 posted7 Dec 2010 (estimated)
  2. Study startDec 2010
  3. Primary completionJan 2011
  4. Study completionJan 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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01255709
Sponsor's protocol ID
API-E004-CL-B3
Status last verified
Feb 2016
First submitted
3 Dec 2010
Last updated
17 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

  • 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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Arm T1: Primatene Mist HFA, Arm T2: Primatene Mist HFA and Arm C: Primatene Mist (epinephrine inhalation aerosol, USP) in people with Asthma, run by Amphastar Pharmaceuticals, Inc. at 1 site 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 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 17 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 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 phase mean?

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?

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?

Pharmacokinetics including maximum concentration and area under the curve (time frame: -30, 2, 5, 7.5, 10, 12.5, 15, 20, 25, 30, 45, 60, 90, 120, 240 and 360 min postdose.). 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 NCT01255709, which also lists 8 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 17 Mar 2016.

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