Special Drug Use Investigation for ADOAIR Metered-dose Inhaler (Pediatric)
- Registration Number
- NCT01332422
- Lead Sponsor
- GlaxoSmithKline
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 300
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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Pediatric patients prescribed ADOAIR Salmeterol and Fluticasone Pediatric patients with asthma prescribed ADOAIR during study period
- Primary Outcome Measures
Name Time Method 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 One year
- Secondary Outcome Measures
Name Time Method