Last updated: 11/07/2018 06:04:17
Special Drug Use Investigation for ADOAIR Metered-dose Inhaler (Pediatric)
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
Trial overview
Official title: Special Drug Use Investigation for ADOAIR Metered-dose Inhaler (Pediatric)
Trial description: 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.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
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
Timeframe: One year
Secondary outcomes:
Not applicable
Interventions:
Drug: Salmeterol and Fluticasone
Enrollment:
300
Observational study model:
Other
Primary completion date:
Not applicable
Time perspective:
Prospective
Clinical publications:
Rie Otake, Junko Minami, Terufumi Hara, Pascal Yoshida.Post-Marketing Surveillance of Salmeterol Xinafoate /Fluticasone Propionate in Pediatric Asthma Patients with Long-Term Administration.Jpn J Pediatr.2014;67(3):107-119
Medical condition
Asthma
Product
fluticasone furoate, fluticasone furoate/vilanterol, fluticasone propionate, fluticasone propionate/salmeterol, salmeterol, vilanterol
Collaborators
Not applicable
Study date(s)
November 2009 to November 2012
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
Not applicable - 14 years
Accepts healthy volunteers
No
- ADOAIR must be used for the first time
- ADOAIR used for a long-term
- Patients with hypersensitivity to salmeterol and fluticasone
- Patients with infection which salmeterol and fluticasone is not effective
Inclusion and exclusion 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
Trial location(s)
No location data available.
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Finalized
Actual primary completion date
Not applicable
Actual study completion date
2012-01-11
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
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