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Completed Phase 3 Interventional Results available

A Safety, Efficacy and Tolerability Study in Pediatric Subjects With Asthma

ClinicalTrials.gov ID: NCT00809757

Public ClinicalTrials.gov record NCT00809757. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 28, 2026, 8:44 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Safety, Efficacy, and Tolerability Study of Daily Dosing With Levalbuterol Tartrate HFA MDI and Placebo in Subjects Aged Birth to <48 Months With Asthma

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

A Safety, Efficacy, and Tolerability Study of Daily Dosing with Levalbuterol Tartrate HFA MDI and Placebo in Subjects Aged Birth to \<48 Months with Asthma.

Study identification

NCT ID
NCT00809757
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Sumitomo Pharma America, Inc.
Industry
Enrollment
197 participants

Conditions and interventions

Conditions

Interventions

Drug

Eligibility (public fields only)

Age range
Up to 48 Months
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Dec 2008 (Type not available)
Primary completion
Jun 2013 (Actual)
Completion
Jun 2013 (Actual)
Last update posted
Jul 28, 2014

2008 – 2013

United States locations

U.S. sites
46
U.S. states
19
U.S. cities
38
Facility City State ZIP Site status
Little Rock Allergy & Asthma Clinical Research Center Little Rock Arkansas 72205 —
West Coast Clinical Trials, LLC Cypress California 90630 —
Allergy & Asthma Care Center of Southern California Long Beach California 90808 —
Clinical Trials of Orange County, Inc. Orange California 92868 —
Allergy and Asthma Consultants Redwood City California 94063 —
IMMUNOe International Research Centers Centennial Colorado 80112 —
All Seasons Allergy and Asthma Center, P.A. Fort Walton Beach Florida 32547 —
Palm Beach Research Center West Palm Beach Florida 33409 —
Brookstone Centre Parkway Columbus Georgia 31904 —
Rush University Medical Center Chicago Illinois 60612 —
Northern Illinois Research Associates DeKalb Illinois 60115 —
Sneeze, Wheeze & Itch Associates LLC Normal Illinois 61761 —
Nassim, McMonigle, Mescia & Associates New Albany Indiana 47150 —
Grand Blanc Medical Grand Blanc Michigan 48439 —
Craig A. Spiegel MD Bridgeton Missouri 63044 —
Midwest Allergy and Asthma center Omaha Nebraska 68130 —
The Asthma & Allergy Center, P.C. Papillion Nebraska 68046 —
Maimonides Medical Center Brooklyn New York 11219 —
St. Elizabeth Health Center Utica New York 13502 —
Cincinnati Children's Hospital Medical Center Cincinnati Ohio 45229 —
Dayton Clinical Research Dayton Ohio 45406 —
Allergy, Asthma and clinical Research Center Oklahoma City Oklahoma 73120 —
Eminence Research, LLC Oklahoma City Oklahoma 73139 —
Asthma and Allergy Research Associates Upland Pennsylvania 19013 —
National Allergy, Asthma, and Uticaria Centers Charleston South Carolina 29407 —
AAC Research - PC Charleston South Carolina 29414 —
ADAC Research, PA Greenville South Carolina 29607 —
The Asthma Institute, PLLC Chattanooga Tennessee 37421 —
Vanderbilt University Medical Center Nashville Tennessee 37203 —
Isis Clinical Research, LLC Austin Texas 78731 —
Sirius Clinical Research, LLC Austin Texas 78759 —
Hill Country Family Medical Center Boerne Texas 78006 —
TTS Research Boerne Texas 78006 —
Allergy/Immunology Research Center of North Texas Dallas Texas 75230 —
Dallas Allergy Immunology Research Dallas Texas 75230 —
Western Sky Medical Research El Paso Texas 79903 —
Breath of Life Research Institute Katy Texas 77450 —
Live Oak Allergy and Asthma Clinic Live Oak Texas 78233 —
Quality Assurance Research Center, Inc. San Antonio Texas 78205 —
Southwest Allergy and Asthma, P.A. San Antonio Texas 78229 —
Sylvana Research Associates San Antonio Texas 78229 —
Allergy & Asthma Care of Waco Waco Texas 76712 —
Allergy and Asthma Research Institute Waco Texas 76712 —
PI-Coor Clinical Research, LLC Burke Virginia 22015 —
Colonial Heights Pediatrics Colonial Heights Virginia 23834 —
Bellingham Asthma, Allergy, & Immunology Clinic Bellingham Washington 98225 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00809757, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jul 28, 2014 · Synced Oct 28, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT00809757 live on ClinicalTrials.gov.

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