Special Drug Use Investigation for ADOAIR Metered-dose Inhaler (Pediatric)
Information source: GlaxoSmithKline
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Asthma
Intervention: Salmeterol and Fluticasone (Drug)
Phase: N/A
Status: Completed
Sponsored by: GlaxoSmithKline Official(s) and/or principal investigator(s): GSK Clinical Trials, Study Director, Affiliation: GlaxoSmithKline
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.
Clinical Details
Official title: Special Drug Use Investigation for ADOAIR Metered-dose Inhaler (Pediatric)
Study design: Time Perspective: Prospective
Primary outcome: 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
Eligibility
Minimum age: N/A.
Maximum age: 14 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Additional Information
Starting date: November 2009
Last updated: July 3, 2014
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