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AsthmaPhase 3NCT01460511

Evaluation of Efficacy and Safety of E004 in Children With Asthma

A Phase 3 study testing E004 (Epinephrine Inhalation Aerosol) HFA-MDI in people with Asthma, run by Amphastar Pharmaceuticals, Inc. at 8 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 is a multi-center, randomized, double-blinded, placebo-controlled, parallel, 4-week study in 60 pediatric patients (4-11 years old) with asthma, comparing E004 with Placebo HFA-MDI in pediatric patients who are 4-11 years of age with asthma. Read more about this study

Who is it for?
Ages 4 to 11 years
Conditions the study is for
Asthma
What is being tested?
E004 (Epinephrine Inhalation Aerosol) HFA-MDI
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
70 participants
Where
8 sitesUnited States
Study dates
Oct 2011to Jul 2012
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 4 to 11 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Generally healthy male, and premenarchal female, children aged 4 - 11 years upon Screening.
  • With documented asthma, requiring inhaled epinephrine or beta2-agonist treatment, with or without concurrent anti-inflammatory therapies for at least 6-months prior to Screening.
  • Being capable of performing spirometry for FEV1
  • Satisfying criteria of asthma
  • Can tolerate withholding treatment with inhaled bronchodilators and other allowed medications for the minimum washout periods
  • Demonstrating a Screening Baseline FEV1 that is 50 - 90% of Polgar predicted normal value.
Show all 9Show fewer
  • Demonstrating an Airway Reversibility,
  • Demonstrating satisfactory techniques in the use of a metered-dose inhaler (MDIs) and a hand held peak expiratory flow meter, after training.
  • Has been properly consented to participate in this study.

Who cannot join

  • Any current or past medical conditions that, per investigator discretion, might significantly affect pharmacodynamic responses to the study drugs
  • Concurrent clinically significant cardiovascular, hematological, renal, neurologic, hepatic, endocrine, psychiatric, or malignant diseases.
  • Known intolerance or hypersensitivity to any component of the study drugs
  • Recent infection of the respiratory tract
  • Use of prohibited medications
  • Having been on other investigational drug/device studies in the last 30 days prior to screening.

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

United States8 sites

  • Amphastar Site 5

    Costa Mesa, California, 92626

  • Amphastar Site 3

    El Paso, Texas, 79903

  • Amphastar Site 2

    Medford, Oregon, 97504

  • Amphastar Site 7

    North Charleston, South Carolina, 29406

  • Amphastar Site 8

    Orange, California, 92868

  • Amphastar Site 1

    Portland, Oregon, 97202

  • Amphastar Site 6

    San Antonio, Texas, 78229

  • Amphastar Site 4

    Stockton, California, 95207

Other trials in United States

About this study

Official title: Phase III Study of Epinephrine Inhalation Aerosol for Evaluation of Efficacy and Safety of E004 in Children With Asthma

This is a multi-center, randomized, double-blinded, placebo-controlled, parallel, 4-week study in 60 pediatric patients (4-11 years old) with asthma, comparing E004 with Placebo HFA-MDI in pediatric patients who are 4-11 years of age with asthma.

Conditions
Asthma
Being tested
E004 (Epinephrine Inhalation Aerosol) HFA-MDI, Placebo-HFA
Keywords
Mild bronchial asthma
Medical subject headings
Asthma

What participants receive

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

  • E004 (Epinephrine Inhalation Aerosol) HFA-MDIDrug

    E004 (Epinephrine Inhalation Aerosol) HFA-MDI, 125 mcg/inhalation, 2 inhalations QID

  • Placebo-HFADrug

    Placebo-HFA, 0 mcg/inhalation, 2 inhalations QID

Study groups in NCT01460511
Study groupRoleWhat they receive
P - Placebo-HFAPlacebo comparatorPlacebo-HFA, 0 mcg/inhalation, 2 inhalations QID
Receives: Drug: Placebo-HFA
T - E004 (Epinephrine Inhalation Aerosol) HFA-MDIExperimentalE004 (Epinephrine Inhalation Aerosol) HFA-MDI, 125 mcg/inhalation, 2 inhalations QID
Receives: Drug: E004 (Epinephrine Inhalation Aerosol) HFA-MDI

What is being measured

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

  1. Primary Efficacy Endpoint AUC of FEV1's relative change

    bronchodilator effect expressed as AUC of FEV1's relative change (from the same day baseline) versus time, defined as AUC of ΔFEV1%.

    Measured: Visit 1 and Visit 3 at 5, 30, 60, 120, 180, 240, and 360 minutes post-dose

Secondary outcomes (11)

  1. AUC of FEV1 volume changes (AUC of change in FEV1)

    determination of the change in FEV1 from baseline at visit to to post treatment at Visit 3

    Measured: Visit 1 and Visit 3 at 5, 30, 60, 120, 180, 240, and 360 minutes post-dose

  2. Maximum of change in FEV1% (Fmax)

    Evaluation of maximum percent change in FEV1

    Measured: Visit 1 and Visit 3 at 5, 30, 60, 120, 180, 240, and 360 minutes post-dose

  3. Curves of change in FEV1, and change in FEV1%, versus time

    Evaluation of curves of change in FEV1 and percent change in FEV1 over time

    Measured: Visit 1 and Visit 3 at 5, 30, 60, 120, 180, 240, and 360 minutes post-dose

  4. Time to onset of bronchodilator effect (to onset), determined the time point (within 60 minutes) where FEV1 first reaches ≥12% above Same-Day Baseline.

    Evaluation of how much time elapses (within 60 minutes), until FEV1 first reaches ≥12% above Same-Day Baseline.

    Measured: Study Visits 1and 3 within 60 minutes post dose

  5. The time to peak FEV1 effect (tmax), defined as the time of Fmax.

    Evaluation of how much time elapses until FEV1 reaches its peak

    Measured: Study Visits 1 and 3 at 5, 30, 60, 120, 180, 240, and 360 minutes post-dose

  6. Duration of efficacy (duration), defined as the total length of time when ΔFEV1% reaches and stays ≥12% above Same-Day Baseline.

    Evaluation of the total length of time it takes until the change in FEV1% reaches and stays ≥12% above Same-Day Baseline.

    Measured: Study Weeks 1and 3 at 5, 30, 60, 120, 180, 240, and 360 minutes post-dose

  7. Percentage of positive responders (R%), including all subjects whose Fmax reaches ≥12% above Same-Day Baseline.

    Evaluation of what percentage of subjects are positive responders (R%), including all subjects whose Fmaxreaches ≥12% above Same-Day Baseline.

    Measured: Study Weeks 1 and 3 within 60 minutes post dose

  8. Mean daily morning pre-dose Peak Expiratory Flow Rate (PEF)

    Evaluation of the mean of daily morning pre-dose Expiratory Flow Rate

    Measured: daily pre-dose

  9. Evaluation of Vital Signs

    Monitoring of vital signs (SBP/DBP, and heart rate) at the Screening Visit (Baseline and 30 min post-dose), and at the baseline, 3, 20, 60 and 360 minute time points during the study

    Measured: predose, and 3, 20, 60, 360 minutes post-dose

  10. 12-lead ECG

    Recording of 12-lead ECG (Routine and QT/QTc) at Screening Visit Baseline, and at the baseline, 3, 20 and 60 minute time points during Study Visits 1 and 3

    Measured: Pre-dose and , 3, 20 and 60 minutes post-dose (Study Visits 1 and 3)

  11. Albuterol HFA usage for rescue relief of acute asthma symptoms

    Evaluation Albuterol HFA usage for rescue relief of acute asthma symptoms

    Measured: Study Visits 1, 2, and 3, within 30 min predose

Timeline

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

  1. First posted27 Oct 2011 (estimated)
  2. Study startOct 2011
  3. Primary completionMar 2012
  4. Study completionJul 2012

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
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
70 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01460511
Sponsor's protocol ID
API-E004-CL-D
Status last verified
Jul 2018
First submitted
24 Oct 2011
Last updated
31 Jul 2018
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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing E004 (Epinephrine Inhalation Aerosol) HFA-MDI in people with Asthma, run by Amphastar Pharmaceuticals, Inc. at 8 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 9 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 31 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 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?

Primary Efficacy Endpoint AUC of FEV1's relative change (time frame: Visit 1 and Visit 3 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 NCT01460511, which also lists 5 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 31 Jul 2018.

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