Evaluation of Efficacy and Safety of E004 in Children With Asthma

Completed · Phase 3 · Has a placebo group

Conditions studied: Asthma

In brief

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.

Key facts

Study ID

NCT01460511

Run by

Amphastar Pharmaceuticals, Inc.

People needed

70

Starts

2011-10-01

Expected to finish

2012-07-01

Last updated by the study team

2018-07-31

Who can join

Age: 4 and older, up to 11. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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