Special Drug Use Investigation for ADOAIR Metered-dose Inhaler (Pediatric)
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.
- Systemic effects accompanying steroid administration; influences on adrenocortical function, influences on bone metabolisms (fracture, osteoporosis, etc.), cataract, glaucoma
- Events related to nervous system, musculoskeletal system and circulatory system; tremor, headache, cramp, tachycardia, etc.
|Study Design:||Time Perspective: Prospective|
|Official Title:||Special Drug Use Investigation for ADOAIR Metered-dose Inhaler (Pediatric)|
- 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 ] [ Designated as safety issue: Yes ]
|Study Start Date:||November 2009|
|Study Completion Date:||November 2012|
|Primary Completion Date:||November 2012 (Final data collection date for primary outcome measure)|
Pediatric patients prescribed ADOAIR
Pediatric patients with asthma prescribed ADOAIR during study period
Drug: Salmeterol and Fluticasone
Collection of safety data
Please refer to this study by its ClinicalTrials.gov identifier: NCT01332422
|Study Director:||GSK Clinical Trials||GlaxoSmithKline|