Study In Airway Physiology In Children - Full Text View

Purpose

Comparison of two asthma treatments by lung function measures.

Condition	Intervention	Phase
Asthma	Drug: Salmeterol/fluticasone propionate Drug: Fluticasone propionate	Phase IV

MedlinePlus related topics:

Asthma

ChemIDplus related topics:

Fluticasone propionate Fluticasone Corticosteroids Salmeterol Salmeterol xinafoate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study

Official Title:	Comparator Study to Demonstrate Superiority of Salmeterol/Fluticasone Propionate 50/100mcg bd Over Fluticasone Propionate 200mcg bd With Respect to Airway Physiology in Children Treated for 6 Weeks.

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

sRAW (k.Pa.s) measured before the study medication dose at the end of treatment (week 6)

Secondary Outcome Measures:

sRAW measured pre-dose at Week 3. sRAW measured 48 hours after last study medication dose. % symptom-free days over Weeks 1-6. % symptom-free nights over Weeks 1-6. Type and frequency of adverse events.

Estimated Enrollment:	64
Study Start Date:	October 2003

Eligibility

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

Criteria

Inclusion criteria:

Currently receiving 200-800mcg/day beclomethasone dipropionate.
sRAW value of 1.3 kPa's.

Exclusion Criteria:

3 or more courses of oral steroids in last 12 months.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00169546

Locations


New Zealand
	GSK Clinical Trials Call Center
	Wellington, New Zealand, 10055

United Kingdom
	GSK Clinical Trials Call Center
	Manchester, United Kingdom, M23 9GP

Sponsors and Collaborators

GlaxoSmithKline

Investigators


Study Director:	GSK Clinical Trials, MD	GlaxoSmithKline

More Information

Study ID Numbers:	SAM40100
First Received:	September 9, 2005
Last Updated:	November 9, 2007
ClinicalTrials.gov Identifier:	NCT00169546
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency; New Zealand: Institutional Review Board

Keywords provided by GlaxoSmithKline:

Asthma

inhaled corticosteroids

Study placed in the following topic categories:

Hypersensitivity

Lung Diseases, Obstructive

Salmeterol

Respiratory Tract Diseases

Lung Diseases

Hypersensitivity, Immediate

Fluticasone

Asthma

Respiratory Hypersensitivity

Additional relevant MeSH terms:

Anti-Inflammatory Agents

Respiratory System Agents

Neurotransmitter Agents

Bronchial Diseases

Immune System Diseases

Adrenergic beta-Agonists

Adrenergic Agents

Molecular Mechanisms of Pharmacological Action

Physiological Effects of Drugs

Anti-Asthmatic Agents

Anti-Allergic Agents

Adrenergic Agonists

Pharmacologic Actions

Autonomic Agents

Therapeutic Uses

Peripheral Nervous System Agents

Dermatologic Agents

Bronchodilator Agents

ClinicalTrials.gov processed this record on September 22, 2008

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00169546