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

Condition(s) targeted: Asthma

Intervention: fluticasone propionate 100mcg HFA (Drug); fluticasone propionate/salmeterol 100/50mcg HFA (Drug)

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
GSK Clinical Trials, MD, Study Director, Affiliation: GlaxoSmithKline

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.

Official title: A Randomized, Double-Blind, Parallel Group Study Evaluating the Safety of Fluticasone Propionate/Salmeterol 100/50mcg HFA (2 Inhalations of 50/25mcg) Twice Daily Compared With Fluticasone Propionate 100mcg HFA (2 Inhalations of 50mcg) Twice Daily in Subjects 4-11 Years of Age With Persistent Asthma

Study design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety Study

Primary outcome: Adverse events Oropharyngeal examinations Asthma exacerbations Electrocardiograms

Secondary outcome: This study has no secondary outcome measures.

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

Criteria:

Inclusion criteria:

- 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%.

Exclusion criteria:

- 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).

GSK Clinical Trials Call Centre, Vina del Mar, Chile

GSK Clinical Trials Call Centre, Santiago, Chile

GSK Clinical Trials Call Centre, San Jose, Costa Rica

GSK Clinical Trials Call Center, Geesthacht 21502, Germany

GSK Clinical Trials Call Center, Bochum 44791, Germany

GSK Clinical Trials Call Center, Mainz 55131, Germany

GSK Clinical Trials Call Center, Gütersloh 33332, Germany

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GSK Clinical Trials Call Centre, Lima Lima 27, Peru

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GSK Clinical Trials Call Center, Long Beach, California 90808, United States

GSK Clinical Trials Call Center, Huntington Beach, California 92647, United States

GSK Clinical Trials Call Center, Denver, Colorado 80230, United States

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GSK Clinical Trials Call Center, Gainesville, Florida 32610, United States

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GSK Clinical Trials Call Center, Cincinnati, Ohio 45231, United States

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Starting date: October 2006
Last updated: January 16, 2008