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Chronic-Dose Safety and Efficacy Study of Albuterol-HFA-MDI In Pediatric Asthmatics

Information source: IVAX Research LLC
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Asthma

Intervention: Albuterol-HFA-MDI and placebo (Drug); Albuterol-HFA-MDI (Drug)

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: IVAX Research LLC

Summary

The primary objective of this study is to evaluate the chronic-dose and efficacy of Albuterol-HFA-MDI relative to placebo in pediatric asthmatics.

Clinical Details

Official title: Phase 3 Study to Evaluate the Chronic-Dose Safety and Efficacy of Albuterol-HFA-MDI Relative to Placebo in Pediatric Asthmatics

Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: The primary objective is to evaluate the chronic-dose safety and efficacy of Albuterol-HFA-MDI relative to placebo in pediatric asthmatics.

Secondary outcome: Baseline-adjusted area-under-the effect curve for percent-=prdicted FEV1 and PEF over six hours post-dose.

Detailed description: Eligiable patients will be randomized to receive one of the following two treatments four times a day for 21 days:

Placebo-HFA-MDI (Albuterol 0 mcg) Albuterol-HFA-MDI (Albuterol 180 mcg)

Eligibility

Minimum age: 4 Years. Maximum age: 11 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Male and female child aged 4-11 years, inclusive Asthma of a minimum of six months

duration that has been stable for at least four weeks prior to screening.

Exclusion Criteria:

- Hospitalization for acute asthma exacerbation greater than two years in 12 months

prior to screening and/or received ER treatment or hospitalization for asthma exacerbation.

Locations and Contacts

Center for Clinical Trials of Sacramento, Sacramento, California 95823, United States

Center for Clinical Trials, LLC, Paramount, California 90723, United States

Integrated Research Group, Inc, Riverside, California 92506, United States

Pediatric Care Medical Group, Inc., Huntington Beach, California 92647, United States

California Allergy & Asthma Medical Group, Palmdale, California 93551, United States

Carlos Piniella, MD, Miami, Florida 33157, United States

Sneeze, Wheeze & Itch Associates, Inc., Normal, Illinois 61761, United States

St. Elizabeth's Children Health Center, Utica, New York 13502, United States

Asthma & Allergy Associates, PC, Elmira, New York 14901, United States

ENT & Allergy Associates, Newburgh, New York 12550, United States

Regional Allergy & Asthma Consultants, Asheville, North Carolina 28801, United States

Clinical Research Institute of Southern Oregan, PC, Medford, Oregon 97504, United States

Virginia Adult & Pediatric Allergy & Asthma, Richmond, Virginia 23229, United States

Additional Information

Starting date: August 2007
Ending date: August 2008
Last updated: June 9, 2008

Page last updated: June 20, 2008

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