Special Drug Use Investigation for ADOAIR (Fluticasone/Salmeterol)

GlaxoSmithKline (GSK)

Status: Completed

Conditions: Respiratory Disorders

Treatments: Drug: Salmeterol and Fluticasone

Study type: Observational

Funder types: Industry

Identifiers

NCT01395862

112278

Details and patient eligibility

About

The purpose of this study is to detect adverse drug reactions for long-term use (particularly clinically significant adverse drug reactions) occurring in clinical settings, to examine factors likely to affect the safety and efficacy in the Japanese asthma patients who are treated with fluticasone propionate/salmeterol xinafoate.

Enrollment: 1,001 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Must use fluticasone and salmeterol for the first time
• Must use fluticasone and salmeterol for long-term

Exclusion criteria

• Patients with hypersensitivity to salmeterol and fluticasone
• Patients with infection which salmeterol and fluticasone is not effective
• Patients with deep mycosis

Trial design

1,001 participants in 1 patient group

Patients prescribed fluticasone and salmeterol

Description:

Patients with asthma prescribed fluticasone and salmeterol for long-term use during study period

Treatment:

Drug: Salmeterol and Fluticasone