Study In Airway Physiology In Children - Full Text View

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

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

Drug Information available for: Corticosteroids Fluticasone Fluticasone propionate Salmeterol Salmeterol xinafoate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, 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:	January 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 Investigational Site
Wellington, New Zealand, 6004
United Kingdom, Lancashire
GSK Investigational Site
Manchester, Lancashire, United Kingdom, M23 9LT

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

More Information

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	SAM40100
Study First Received:	September 9, 2005
Last Updated:	October 15, 2008
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 January 13, 2009