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Completed

NCT Number: NCT00920543

GSK BHR Study (Sont)

The purpose of this study was to determine whether asthma control and reduced bronchial hyperresponsiveness could be achieved and maintained at a lower dose of inhaled corticosteroids with ADVAIR DISKUS twice-daily or FP twice-daily in adult and adolescent subjects with persistent asthma

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Key information

Conditions

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

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

GSK Investigational Site, Salvador, Estado de Bahia, Brazil

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Asthma diagnosis
  • Controller medications or moderate inhaled corticosteroid dose
  • Evidence of reversibility

Exclusion criteria

  • Life-threatening asthma
  • Asthma instability
  • Concurrent respiratory disease
  • Drug allergy
  • Respiratory tract infection
  • Systemic corticosteroid use
  • Immunosuppressive medication use
  • Positive pregnancy test
  • Tobacco use
  • Site affiliation

Treatment and study plan

Placebo

Drug

Twice daily dosing

FP 100mcg

Drug

Twice daily dosing

FP 500mcg

Drug

Twice daily dosing

FP 250mcg

Drug

Twice daily dosing

FSC 100/50mcg

Drug

Twice daily dosing

FSC 250/50mcg

Drug

Twice daily dosing

FSC 500/50mcg

Drug

Twice daily dosing

Primary outcomes

  1. Average inhaled corticosteroid treatment dose over the treatment period

    Time frame: Every 8 weeks for the 40 week treatment period

Secondary outcomes

  1. Pulmonary function measures

    Time frame: Every 8 weeks for the 40 week treatment period

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

A Multicenter, Randomized, Double-blind, Parallel Group, 40-week Comparison of Asthma Control Using Bronchial Hyperresponsiveness as an Additional Guide to Long-term Treatment in Adolescents and Adults Receiving Either Fluticasone Propionate/Salmeterol DISKUS Twice Daily or Fluticasone Propionate DISKUS Twice Daily (or Placebo BID if Asymptomatic)

Important dates

Study start
2003
Primary completion
2004
Study completion
2004
First posted
Jun 15, 2009
Registry last updated
Sep 1, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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