A 12-Week Study To Assess The Safety Of Fluticasone Propionate/Salmeterol 100/50 Hydrofluoroalkane (HFA) Versus Fluticasone Propionate 100 HFA In Children With Asthma

Completed · Phase 3

Conditions studied: Asthma

In brief

This study is to assess the safety of an investigational drug in children 4 to 11 years of age who have asthma. The subjects will attend 7 clinic visits, of which up to 3 will be in the morning, and have lung function tests performed.

Key facts

Study ID

NCT00441441

Run by

GlaxoSmithKline

People needed

351

Starts

2007-02-01

Expected to finish

2008-01-01

Last updated by the study team

2016-12-16

Who can join

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

You may qualify if…

• Must have asthma.
• Must be currently taking an inhaled corticosteroid.
• Must be able to attend 7 clinic visits, of which up to 3 will be in the morning, and have lung function tests that are at least 60% of normal (AM FEV1 or PEF).
• Have a historical or current FEV1 or PEF reversibility of >=12%.

You may not qualify if…

• Has ever had life-threatening asthma (for example respiratory arrest, mechanical ventilation).
• Has a current ear or respiratory tract infection.
• Has ever had any other major illnesses (such as cystic fibrosis, heart problems, tuberculosis).

Where it is running

• GSK Investigational Site — Long Beach, California, United States
• GSK Investigational Site — Long Beach, California, United States
• GSK Investigational Site — Riverside, California, United States
• GSK Investigational Site — Denver, Colorado, United States
• GSK Investigational Site — Lakewood, Colorado, United States
• GSK Investigational Site — Jacksonville, Florida, United States
• GSK Investigational Site — Gainesville, Georgia, United States
• GSK Investigational Site — Ypsilanti, Michigan, United States
• GSK Investigational Site — Cortland, New York, United States
• GSK Investigational Site — Raleigh, North Carolina, United States
• GSK Investigational Site — Canton, Ohio, United States
• GSK Investigational Site — Oklahoma City, Oklahoma, United States
• GSK Investigational Site — Lake Oswego, Oregon, United States
• GSK Investigational Site — Medford, Oregon, United States
• GSK Investigational Site — Portland, Oregon, United States
• GSK Investigational Site — Pittsburgh, Pennsylvania, United States
• GSK Investigational Site — Charleston, South Carolina, United States
• GSK Investigational Site — Germantown, Tennessee, United States
• GSK Investigational Site — South Burlington, Vermont, United States
• GSK Investigational Site — Clayton, Victoria, Australia
• GSK Investigational Site — Parkville, Victoria, Australia
• GSK Investigational Site — Subiaco, Western Australia, Australia
• GSK Investigational Site — St. John's, Newfoundland and Labrador, Canada
• GSK Investigational Site — Brampton, Ontario, Canada
• GSK Investigational Site — Huntington Beach, California, United States

Full record on ClinicalTrials.gov

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