Last updated on September 2017

Effects of a Orally Inhaled Fluticasone Furoate on Growth Velocity in Prepubertal Paediatric Subjects With Asthma Over a Year


Brief description of study

There is a regulatory requirement to evaluate the extent of reduction (if any) of growth velocity associated with inhaled corticosteroid (ICS) containing products that are to be administered to children, and to this end there is Food and Drug Administration (FDA) regulatory guidance. This is a randomised, single-blind (run-in period)/double-blind (treatment period), parallel group, placebo controlled, multicentre study to assess the effect of once daily (OD) inhaled fluticasone furoate (FF) 50 microgram (mcg) on growth velocity in prepubertal asthmatic children on a background therapy of open-label montelukast. This study will be conducted over a total duration of approximately 76 weeks: 16-week run-in period (single-blind placebo inhaler), 52-week double-blind treatment period (inhaled FF 50 mcg /placebo administered OD in the morning for 52 weeks) and 8-week follow-up period. The purpose of the study is to evaluate the magnitude of effect (with a level of precision) on growth velocity of prepubertal asthmatic paediatric subjects (aged 5 to <9 years) following administration of OD inhaled FF 50 mcg for one year. This study fulfills European Union (EU) and United States (US) regulatory requirements for the evaluation of potential growth suppression in children.

Clinical Study Identifier: NCT02889809

.

Contact Investigators or Research Sites near you

Start Over

Please choose location

View all locations

US GSK Clinical Trials Call ...

GSK Investigational Site
Little Rock, AR United States
  Connect »

US GSK Clinical Trials Call ...

GSK Investigational Site
Huntington Beach, CA United States
  Connect »

US GSK Clinical Trials Call ...

GSK Investigational Site
Rolling Hills Estates, CA United States
  Connect »

US GSK Clinical Trials Call ...

GSK Investigational Site
Homestead, FL United States
  Connect »

US GSK Clinical Trials Call ...

GSK Investigational Site
Loxahatchee Groves, FL United States
  Connect »

US GSK Clinical Trials Call ...

GSK Investigational Site
Miami, FL United States
  Connect »

US GSK Clinical Trials Call ...

GSK Investigational Site
Ocala, FL United States
  Connect »

US GSK Clinical Trials Call ...

GSK Investigational Site
Saint Petersburg, FL United States
  Connect »

US GSK Clinical Trials Call ...

GSK Investigational Site
Gainesville, GA United States
  Connect »

US GSK Clinical Trials Call ...

GSK Investigational Site
Ypsilanti, MI United States
  Connect »

US GSK Clinical Trials Call ...

GSK Investigational Site
Bellevue, NE United States
  Connect »

US GSK Clinical Trials Call ...

GSK Investigational Site
Raleigh, NC United States
  Connect »

US GSK Clinical Trials Call ...

GSK Investigational Site
Oklahoma City, OK United States
  Connect »

US GSK Clinical Trials Call ...

GSK Investigational Site
Medford, OR United States
  Connect »

US GSK Clinical Trials Call ...

GSK Investigational Site
Pittsburgh, PA United States
  Connect »

US GSK Clinical Trials Call ...

GSK Investigational Site
Orangeburg, SC United States
  Connect »

US GSK Clinical Trials Call ...

GSK Investigational Site
San Antonio, TX United States
  Connect »

US GSK Clinical Trials Call ...

GSK Investigational Site
Waco, TX United States
  Connect »

US GSK Clinical Trials Call ...

GSK Investigational Site
Bialystok, Poland
  Connect »

US GSK Clinical Trials Call ...

GSK Investigational Site
Bydgoszcz, Poland
  Connect »

US GSK Clinical Trials Call ...

GSK Investigational Site
Skarzysko-Kamienna, Poland
  Connect »

US GSK Clinical Trials Call ...

GSK Investigational Site
Szczecin, Poland
  Connect »

US GSK Clinical Trials Call ...

GSK Investigational Site
Tarnow, Poland
  Connect »

US GSK Clinical Trials Call ...

GSK Investigational Site
Moscow, Russian Federation
  Connect »

US GSK Clinical Trials Call ...

GSK Investigational Site
Novosibirsk, Russian Federation
  Connect »

US GSK Clinical Trials Call ...

GSK Investigational Site
St.Petersburg, Russian Federation
  Connect »

US GSK Clinical Trials Call ...

GSK Investigational Site
Tomsk, Russian Federation
  Connect »

US GSK Clinical Trials Call ...

GSK Investigational Site
Voronezh, Russian Federation
  Connect »

US GSK Clinical Trials Call ...

GSK Investigational Site
Yaroslavl, Russian Federation
  Connect »

US GSK Clinical Trials Call ...

GSK Investigational Site
Pretoria, South Africa
  Connect »

US GSK Clinical Trials Call ...

GSK Investigational Site
Middelburg, South Africa
  Connect »

US GSK Clinical Trials Call ...

GSK Investigational Site
Bellville, South Africa
  Connect »

US GSK Clinical Trials Call ...

GSK Investigational Site
Cape Town, South Africa
  Connect »