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Study In Airway Physiology In Children SERETIDE DISKUS ® Inhlaer and FLIXOTIDE® Inhaler Are Trademarks of GSK Group of Companies.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00169546
First received: September 9, 2005
Last updated: September 13, 2016
Last verified: September 2016
  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 (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Randomised, Double-blind Parallel Group Study to Assess the Bronchodilative and Bronchoprotective Properties of SERETIDE DISKUS ® Inhlaer 50/100mcg Twice Daily vs. FLIXOTIDE® Inhaler 200mcg Twice Daily.

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.

Enrollment: 64
Study Start Date: January 2003
Study Completion Date: December 2005
Primary Completion Date: December 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1 Drug: Salmeterol/fluticasone propionate Drug: Fluticasone propionate
Other Name: Salmeterol/fluticasone propionate

  Eligibility

Ages Eligible for Study:   4 Years to 11 Years   (Child)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 GlaxoSmithKline
  More Information

Additional Information:
Publications:
This study has not been published in the scientific literature.

Study Data/Documents: Annotated Case Report Form  This link exits the ClinicalTrials.gov site
Identifier: SAM40100
For additional information about this study please refer to the GSK Clinical Study Register
Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: SAM40100
For additional information about this study please refer to the GSK Clinical Study Register
Clinical Study Report  This link exits the ClinicalTrials.gov site
Identifier: SAM40100
For additional information about this study please refer to the GSK Clinical Study Register
Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: SAM40100
For additional information about this study please refer to the GSK Clinical Study Register
Informed Consent Form  This link exits the ClinicalTrials.gov site
Identifier: SAM40100
For additional information about this study please refer to the GSK Clinical Study Register
Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: SAM40100
For additional information about this study please refer to the GSK Clinical Study Register
Statistical Analysis Plan  This link exits the ClinicalTrials.gov site
Identifier: SAM40100
For additional information about this study please refer to the GSK Clinical Study Register

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00169546     History of Changes
Other Study ID Numbers: SAM40100 
Study First Received: September 9, 2005
Last Updated: September 13, 2016
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
New Zealand: Institutional Review Board
Individual Participant Data  
Plan to Share IPD: Yes
Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Keywords provided by GlaxoSmithKline:
Asthma
inhaled corticosteroids

Additional relevant MeSH terms:
Fluticasone
Fluticasone Propionate, Salmeterol Xinafoate Drug Combination
Salmeterol Xinafoate
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents
Anti-Allergic Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Sympathomimetics
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on December 07, 2016