NCT01460511

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at below P25 for phase_3 asthma

Timeline
Completed

Started Oct 2011

Shorter than P25 for phase_3 asthma

Geographic Reach
1 country

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2011

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

October 24, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 27, 2011

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
Last Updated

July 31, 2018

Status Verified

July 1, 2018

Enrollment Period

5 months

First QC Date

October 24, 2011

Last Update Submit

July 27, 2018

Conditions

Asthma

Keywords

Mild bronchial asthma

Outcome Measures

Primary Outcomes (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%.

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

Secondary Outcomes (11)

  • AUC of FEV1 volume changes (AUC of change in FEV1)

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

  • Maximum of change in FEV1% (Fmax)

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

  • Curves of change in FEV1, and change in FEV1%, versus time

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

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

    Study Visits 1and 3 within 60 minutes post dose

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

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

  • +6 more secondary outcomes

Study Arms (2)

P - Placebo-HFA

PLACEBO COMPARATOR

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

Drug: Placebo-HFA

T - E004 (Epinephrine Inhalation Aerosol) HFA-MDI

EXPERIMENTAL

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

Drug: E004 (Epinephrine Inhalation Aerosol) HFA-MDI

Interventions

E004 (Epinephrine Inhalation Aerosol) HFA-MDIDRUG

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

T - E004 (Epinephrine Inhalation Aerosol) HFA-MDI
Placebo-HFADRUG

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

P - Placebo-HFA

Eligibility Criteria

Age4 Years - 11 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.
  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Amphastar Site 5

Costa Mesa, California, 92626, United States

Location

Amphastar Site 8

Orange, California, 92868, United States

Location

Amphastar Site 4

Stockton, California, 95207, United States

Location

Amphastar Site 2

Medford, Oregon, 97504, United States

Location

Amphastar Site 1

Portland, Oregon, 97202, United States

Location

Amphastar Site 7

North Charleston, South Carolina, 29406, United States

Location

Amphastar Site 3

El Paso, Texas, 79903, United States

Location

Amphastar Site 6

San Antonio, Texas, 78229, United States

Location

Related Publications (5)

  • 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.

    PMID: 2019665BACKGROUND

  • 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.

    PMID: 16400891BACKGROUND

  • 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.

    PMID: 3780129BACKGROUND

  • 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.

    PMID: 10919679BACKGROUND

  • 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.

    PMID: 10936150BACKGROUND

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • John Gao, M.D.

    Amphastar Pharmaceuticals, Inc.

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 24, 2011

First Posted

October 27, 2011

Study Start

October 1, 2011

Primary Completion

March 1, 2012

Study Completion

July 1, 2012

Last Updated

July 31, 2018

Record last verified: 2018-07

Locations

US(8)