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

NCT00169546 | Completed Phase 4

• 1 other identifier: SAM40100
• Study Type: interventional
• Target: 64
• Locations: 2 countries
• Sites: 2

Brief Summary

Comparison of two asthma treatments by lung function measures.

Conditions

Asthma

Keywords

Asthma; inhaled corticosteroids

Outcome Measures

Primary Outcomes (1)

• sRAW (k.Pa.s) measured before the study medication dose at the end of treatment (week 6)

Secondary Outcomes (1)

• 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.

Study Arms (1)

Arm 1

EXPERIMENTAL

Drug: Salmeterol/fluticasone propionate; Drug: Fluticasone propionate

Interventions

Salmeterol/fluticasone propionate DRUG

Arm 1

Fluticasone propionate DRUG

Also known as: Salmeterol/fluticasone propionate

Arm 1

Eligibility Criteria

• Age: 4 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Currently receiving 200-800mcg/day beclomethasone dipropionate.
• sRAW value of 1.3 kPa's.

You may not qualify if:

• or more courses of oral steroids in last 12 months.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (2)

GSK Investigational Site

Wellington, 6004, New Zealand

Location

GSK Investigational Site

Manchester, Lancashire, M23 9LT, United Kingdom

Location

Related Publications (1)

• This study has not been published in the scientific literature.

  BACKGROUND

Related Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

MeSH Terms

Conditions

Asthma

Interventions

Fluticasone-Salmeterol Drug Combination; Fluticasone

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Salmeterol Xinafoate; Albuterol; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Phenethylamines; Ethylamines; Androstadienes; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Drug Combinations; Pharmaceutical Preparations

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2005
• First Posted: September 15, 2005
• Study Start: January 1, 2003
• Primary Completion: December 1, 2005
• Study Completion: December 1, 2005
• Last Updated: September 15, 2016

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will share

Locations

NZ (1); GB (1)