Last updated: 11/07/2018 04:37:41
Special Drug Use Investigation for ADOAIR (fluticasone/salmeterol)
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 (fluticasone/salmeterol)
Trial description: The purpose of this study is to detect adverse drug reactions for long-term use (particularly clinically significant adverse drug reactions) occurring in clinical settings, to examine factors likely to affect the safety and efficacy in the Japanese asthma patients who are treated with fluticasone propionate/salmeterol xinafoate.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
The number of incidence of adverse events in Japanese asthma patients treated with fluticasone and salmeterol for long-term
Timeframe: 1 year
Secondary outcomes:
Not applicable
Interventions:
Drug: Salmeterol and Fluticasone
Enrollment:
1001
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 Asthma Patients with Long-Term Administration.J Clin Therapeut Med.2014;30(4):303-318
Medical condition
Respiratory Disorders
Product
fluticasone propionate, fluticasone propionate/salmeterol, salmeterol
Collaborators
Not applicable
Study date(s)
November 2007 to September 2012
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
Not applicable+ years
Accepts healthy volunteers
No
- Must use fluticasone and salmeterol for the first time
- Must use fluticasone and salmeterol for 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:
- Must use fluticasone and salmeterol for the first time
- Must use fluticasone and salmeterol for 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
2012-28-09
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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