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
Finalized
Finalized
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:
Drug: Salmeterol and Fluticasone
Enrollment:
2000
Observational study model:
Other
Primary completion date:
Not applicable
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
Finalized
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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