Special Drug Use Investigation for ADOAIR Metered-dose Inhaler (Pediatric)

GlaxoSmithKline (GSK)

Status: Completed

Conditions: Asthma

Treatments: Drug: Salmeterol and Fluticasone

Study type: Observational

Funder types: Industry

Identifiers

NCT01332422

113405

Details and patient eligibility

About

To investigate possible problems or questions in safety and efficacy of ADOAIR 100 DISKUS and ADOAIR 50 AEROSOL 120 in Japanese pediatric patients with bronchial asthma for a long term under the practical use conditions. In this special drug use investigation, the following items shall be handled as the priority investigation items for information collection.

1. Systemic effects accompanying steroid administration; influences on adrenocortical function, influences on bone metabolisms (fracture, osteoporosis, etc.), cataract, glaucoma
2. Events related to nervous system, musculoskeletal system and circulatory system; tremor, headache, cramp, tachycardia, etc.

Enrollment: 300 patients

Sex: All

Ages: Under 14 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• ADOAIR must be used for the first time
• ADOAIR used for a 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

300 participants in 1 patient group

Pediatric patients prescribed ADOAIR

Description:

Pediatric patients with asthma prescribed ADOAIR during study period

Treatment:

Drug: Salmeterol and Fluticasone