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

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.

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:

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

No publications provided

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	SAM40100
Study First Received:	September 9, 2005
Last Updated:	October 15, 2008
ClinicalTrials.gov Identifier:	NCT00169546 History of Changes
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:

Anti-Inflammatory Agents
Neurotransmitter Agents
Salmeterol
Bronchial Diseases
Adrenergic Agents
Adrenergic beta-Agonists
Anti-Asthmatic Agents
Asthma
Anti-Allergic Agents
Adrenergic Agonists

Lung Diseases, Obstructive
Hypersensitivity
Respiratory Tract Diseases
Lung Diseases
Hypersensitivity, Immediate
Fluticasone
Peripheral Nervous System Agents
Bronchodilator Agents
Respiratory Hypersensitivity

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 July 02, 2009