NCT01687296 - Nebulized Fluticasone Propionate VS Oral Prednisone in Chinese Pediatric and Adolescent Subjects With an Acute Exacerbation of Asthma | Biotech Hunter

Enrollment

261

Participants

Timeline

Start Date

November 12, 2012

Primary Completion Date

June 1, 2013

Study Completion Date

June 21, 2013

Conditions

Asthma

Interventions

DRUG

fluticasone propionate inhalation solution

2×0.5mg/2ml twice daily nebulized to treat an acute exacerbation of asthma for 7 days

DRUG

oral prednisone

once daily (2mg/kg.day, up to 40mg/day for 4 days, then 1mg/kg.day or half of the original dose, up to 20mg/day for 3 days) to treat an acute exacerbation of asthma for 7 days

DRUG

placebo inhalation solution

4ml 0.9% saline nebulized twice daily

DRUG

placebo tablet

placebo soluble tablet, oral ,once daily

DRUG

salbutamol

Salbutamol MDI 2 puffs twice daily or Nebules twice daily, and can be increased up to every 4 hours on an as-needed basis, through the treatment period.

Trial Locations (11)

100191

GSK Investigational Site, Beijing

110004

GSK Investigational Site, Shenyang

133000

GSK Investigational Site, Yanji

200040

GSK Investigational Site, Shanghai

200092

GSK Investigational Site, Shanghai

214023

GSK Investigational Site, Wuxi

323027

GSK Investigational Site, Wenzhou

400014

GSK Investigational Site, Chongqing

410005

GSK Investigational Site, Changsha

Unknown

GSK Investigational Site, Beijing

GSK Investigational Site, Changchun