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

This study has been completed.

First Received: February 28, 2007 Last Updated: October 15, 2008 History of Changes

Sponsor:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00441441

Purpose

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.

Condition	Intervention	Phase
Asthma	Drug: fluticasone propionate 100mcg HFA Drug: fluticasone propionate/salmeterol 100/50mcg HFA	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Parallel Assignment, Safety Study
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

Resource links provided by NLM:

MedlinePlus related topics: Asthma

Drug Information available for: Fluticasone propionate Salmeterol Fluticasone Salmeterol xinafoate

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Adverse events Oropharyngeal examinations Asthma exacerbations Electrocardiograms

Secondary Outcome Measures:

This study has no secondary outcome measures.

Estimated Enrollment:	300
Study Start Date:	February 2007

Eligibility

Ages Eligible for Study:	4 Years to 11 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00441441

Show 50 Study Locations

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	SFA106484
Study First Received:	February 28, 2007
Last Updated:	October 15, 2008
ClinicalTrials.gov Identifier:	NCT00441441 History of Changes
Health Authority:	United States: Food and Drug Administration; Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by GlaxoSmithKline:

asthma
children
fluticasone propionate/salmeterol
fluticasone propionate

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Respiratory System Agents
Neurotransmitter Agents
Bronchial Diseases
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Adrenergic Agonists
Hypersensitivity
Lung Diseases, Obstructive
Respiratory Tract Diseases
Therapeutic Uses
Fluticasone
Dermatologic Agents

Salmeterol
Adrenergic beta-Agonists
Immune System Diseases
Asthma
Anti-Asthmatic Agents
Anti-Allergic Agents
Pharmacologic Actions
Autonomic Agents
Lung Diseases
Hypersensitivity, Immediate
Peripheral Nervous System Agents
Bronchodilator Agents
Respiratory Hypersensitivity

ClinicalTrials.gov processed this record on February 08, 2010