Evaluation of Efficacy and Safety of E004 in Children With Asthma
NCT ID: NCT01460511
Last Updated: 2018-07-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
70 participants
INTERVENTIONAL
2011-10-31
2012-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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P - Placebo-HFA
Placebo-HFA, 0 mcg/inhalation, 2 inhalations QID
Placebo-HFA
Placebo-HFA, 0 mcg/inhalation, 2 inhalations QID
T - E004 (Epinephrine Inhalation Aerosol) HFA-MDI
E004 (Epinephrine Inhalation Aerosol) HFA-MDI, 125 mcg/inhalation, 2 inhalations QID
E004 (Epinephrine Inhalation Aerosol) HFA-MDI
E004 (Epinephrine Inhalation Aerosol) HFA-MDI, 125 mcg/inhalation, 2 inhalations QID
Interventions
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E004 (Epinephrine Inhalation Aerosol) HFA-MDI
E004 (Epinephrine Inhalation Aerosol) HFA-MDI, 125 mcg/inhalation, 2 inhalations QID
Placebo-HFA
Placebo-HFA, 0 mcg/inhalation, 2 inhalations QID
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
4 Years
11 Years
ALL
No
Sponsors
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Amphastar Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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John Gao, M.D.
Role: STUDY_CHAIR
Amphastar Pharmaceuticals, Inc.
Locations
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Amphastar Site 5
Costa Mesa, California, United States
Amphastar Site 8
Orange, California, United States
Amphastar Site 4
Stockton, California, United States
Amphastar Site 2
Medford, Oregon, United States
Amphastar Site 1
Portland, Oregon, United States
Amphastar Site 7
North Charleston, South Carolina, United States
Amphastar Site 3
El Paso, Texas, United States
Amphastar Site 6
San Antonio, Texas, United States
Countries
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References
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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.
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.
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.
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.
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.
Other Identifiers
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API-E004-CL-D
Identifier Type: -
Identifier Source: org_study_id
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