Last updated: 11/03/2018 14:13:52
Special Drug Use Investigation for ADOAIR DISKUS COPD (salmeterol and fluticasone)
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: Special Drug Use Investigation for ADOAIR DISKUS COPD (salmeterol and fluticasone)
Trial description: To investigate possible problems or questions in safety and effectiveness of salmeterol and fluticasone in patients with chronic obstructive pulmonary disease (bronchitis chronic / emphysema). In this special drug use investigation, onset of pneumonia shall be handled as the priority investigation item.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
The incidence of adverse events in Japanese patients treated with salmeterol and fluticasone based on prescribing information under the conditions of general clinical practice.
Timeframe: 1 year
Secondary outcomes:
Not applicable
Interventions:
Enrollment:
2000
Primary completion date:
Not applicable
Observational study model:
Other
Time perspective:
Prospective
Clinical publications:
Yoriko Morioka, Hiroharu Abe, Terufumi Hara, Pascal Yoshida. Post-marketing Surveillance of Salmeterol Xinafoate / Fluticasone Propionate (Adoair®250Diskus®) - Interim Report -. Resp Med - Kokyuki Naika. 2013;23(1):111-122.
Junko Minami, Akihiro Kobayashi, Terufumi Hara, Pascal Yoshida.Safety and Effectiveness of Salmeterol Xinafoate/Fluticasone Propionate Combination Inhaler (Adoair® 250 Diskus®) in Patients with Chronic Obstructive Pulmonary Disease: Final Report of Long-term Special Drug Use Investigation.Ther Res.2014;35(4):433-447
Medical condition
Pulmonary Disease, Chronic Obstructive
Product
fluticasone propionate, fluticasone propionate/salmeterol, salmeterol
Collaborators
Not applicable
Study date(s)
August 2009 to August 2012
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
Not applicable+ years
Accepts healthy volunteers
No
- Must use salmeterol and fluticasone for the first time
- 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 salmeterol and fluticasone for the first time
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)
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
Study complete
Actual primary completion date
Not applicable
Actual study completion date
2012-30-08
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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