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

GlaxoSmithKline300 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

300

Conditions

Asthma

Interventions

Salmeterol and FluticasoneDRUG

Collection of safety data

Eligibility

Sex: ALLMax age: 14 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Safety and efficacy for a long term under the practical use conditions. As the priority investigation items, (1)Systemic effects accompanying steroid administration (2) Events related to nervous system, musculoskeletal system and circulatory systems

Time frame: One year