Who is sponsoring NCT00449046?

NCT00449046 is sponsored by GlaxoSmithKline.

What condition does NCT00449046 study?

NCT00449046 studies Bronchial Asthma.

What drugs are being tested in NCT00449046?

Interventions: GW815SF Salmeterol/Fluticasone propionate(HFA MDI).

What is the status of NCT00449046?

NCT00449046 is currently COMPLETED.

Last reviewed 2015-04-16 · How we verify

Clinical Assessment of GW815SF Salmeterol/Fluticasone Propionate (HFA MDI) in Pediatric Patients With Bronchial Asthma -A Long Term (24-week) Study-

NCT00449046 Phase 3 COMPLETED Results posted

This study evaluates the long-term (24-week) safety and efficacy of GW815SF Salmeterol/fluticasone propionate(HFA MDI) 50/100mcg(administered as 2 inhalations of 25/50mcg) bid in pediatric patients with bronchial asthma.

Details

Lead sponsor	GlaxoSmithKline
Phase	Phase 3
Status	COMPLETED
Enrolment	40
Start date	2007-03
Completion	2007-11

Conditions

Bronchial Asthma

Interventions

GW815SF Salmeterol/Fluticasone propionate(HFA MDI)

Primary outcomes

Most Frequent Adverse Events - On Therapy — Baseline to Week 24
Adverse events, Clinical laboratory tests, Adrenocortical function test, Physical examinations, 12-lead electrocardiogram (ECG), Oropharyngeal examination were included.
Serious Adverse Events (SAEs) - On Therapy — Baseline to Week 24
Number of participants considered by the investigator to be related to study medication. Adverse events, Clinical laboratory tests, Adrenocortical function test, Physical examinations, 12-lead ECG, Oropharyngeal examination were included. Frequency threshold of reported SAE's is 0%(100% reported)

Countries

Japan