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OpenTrials
Completed

NCT Number: NCT00920959

Advair Pediatric Once-Daily

To demonstrate if once-daily dosing of ADVAIR 100/50 once-daily has superior efficacy and comparable safety compared with FP 100mcg once-daily in pediatric subjects 4 to 11 years of age with asthma.

Completed

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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

4 year–11 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

GSK Investigational Site, Buenos Aires, Argentina

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Out-patients
  • Asthma diagnosis
  • Reversibility
  • Short-acting beta-agonist or asthma controlled medication use

Exclusion criteria

  • Life-threatening asthma
  • Specified asthma medications
  • Chickenpox
  • Drug allergy
  • Respiratory infections
  • Tobacco use
  • Clinical laboratory abnormalities
  • Ophthalmologic conditions
  • Investigation medications
  • Affiliation with investigator site

Treatment and study plan

FP 100mcg

Drug

Once-daily dosing

FSC 100/50mcg

Drug

Once-daily dosing

Placebo

Drug

Once-daily dosing

Primary outcomes

  1. Change from baseline at endpoint in daily PM PEF

    Time frame: 12 weeks

Secondary outcomes

  1. Various pulmonary function endpoints

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

A Stratified, Randomized, Double-blind, Placebo-controlled, Parallel-group, 12 Week Trial Evaluating the Safety and Efficacy of Fluticasone Propionate/Salmeterol DISKUS Combination Product 100/50mcg Once Daily Versus Fluticasone Propionate DISKUS 100mcg Once Daily and Placebo in Symptomatic Pediatric Subjects (4-11 Years) With Asthma

Important dates

Study start
2001
Primary completion
2004
Study completion
2004
First posted
Jun 15, 2009
Registry last updated
Sep 15, 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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