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Study In Airway Physiology In Children

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00169546
First received: September 9, 2005
Last updated: October 15, 2008
Last verified: October 2008
History of Changes
  Purpose

Comparison of two asthma treatments by lung function measures.


Condition Intervention Phase
Asthma
 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:

MedlinePlus related topics: Asthma
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
Intervention Details:
    Drug: Salmeterol/fluticasone propionate Drug: Fluticasone propionate
    Other Names:
    • Salmeterol/fluticasone propionate
    • Fluticasone propionate
  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
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: Study Director, GSK
ClinicalTrials.gov 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:
Asthma
inhaled corticosteroids

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Salmeterol
Fluticasone
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
 Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Dermatologic Agents
Anti-Allergic Agents
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on May 16, 2013