Study In Airway Physiology In Children

This study has been completed.
Information provided by:
GlaxoSmithKline Identifier:
First received: September 9, 2005
Last updated: October 15, 2008
Last verified: October 2008
Comparison of two asthma treatments by lung function measures.

Condition Intervention Phase
Drug: Salmeterol/fluticasone propionate
Drug: Fluticasone propionate
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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:

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
Intervention Details:
    Drug: Salmeterol/fluticasone propionate Drug: Fluticasone propionate
    Other Name: Salmeterol/fluticasone propionate

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

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
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Please refer to this study by its identifier: NCT00169546

New Zealand
GSK Investigational Site
Wellington, New Zealand, 6004
United Kingdom
GSK Investigational Site
Manchester, Lancashire, United Kingdom, M23 9LT
Sponsors and Collaborators
Study Director: GSK Clinical Trials, MD GlaxoSmithKline
  More Information

Responsible Party: Study Director, GSK Identifier: NCT00169546     History of Changes
Other Study ID Numbers: SAM40100 
Study First Received: September 9, 2005
Last Updated: October 15, 2008
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
New Zealand: Institutional Review Board

Keywords provided by GlaxoSmithKline:
inhaled corticosteroids

Additional relevant MeSH terms:
Salmeterol Xinafoate
Adrenergic Agents
Adrenergic Agonists
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Anti-Allergic Agents
Anti-Asthmatic Agents
Anti-Inflammatory Agents
Autonomic Agents
Bronchodilator Agents
Dermatologic Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Respiratory System Agents processed this record on May 26, 2016