Last updated: 07/28/2020 03:50:15
A post-marketing surveillance study of AvamysTM (Fluticasone furoate) in the treatment of Filipino patients with Allergic Rhinitis (AR)Avamys PMS
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
Trial overview
Official title: A post-marketing surveillance study of AvamysTM (Fluticasone furoate) in the treatment of Filipino patients with Allergic Rhinitis (AR)
Trial description: This is a regulatory manadated post marketing surveillance study for all products under monitored release in the Philippines.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Adverse event reports
Timeframe: within two weeks of use
Secondary outcomes:
None
Timeframe: None
Interventions:
Drug: Avamys
Enrollment:
421
Observational study model:
Other
Primary completion date:
2013-08-01
Time perspective:
Prospective
Clinical publications:
Joselito C. Javier, Sheila C. Chua, Giovell P. Barangan.Safety of Fluticasone Furoate Nasal Spray Among Filipino Patients with Allergic Rhinitis: A Post-Marketing Surveillance Study.Philipp J Intern Med.2018;56(1):48-55
Medical condition
Rhinitis, Allergic, Perennial and Seasonal
Product
fluticasone furoate
Collaborators
Not applicable
Study date(s)
August 2010 to January 2013
Type
Observational
Phase
4
Participation criteria
Sex
Female & Male
Age
2 - 80 Year
Accepts healthy volunteers
none
- Patients (pediatric starting at two years and above; and adults) with clinically diagnosed Allergic Rhinitis (AR)
- Patients must give written informed consent to take part in the study (for pediatric patients, then the parent or legal guardian should give the consent)
- Patients with known hypersensitivity to Fluticasone furoate or any component of the preparation
Inclusion and exclusion criteria
Inclusion criteria:
- Patients (pediatric starting at two years and above; and adults) with clinically diagnosed Allergic Rhinitis (AR)
- Patients must give written informed consent to take part in the study (for pediatric patients, then the parent or legal guardian should give the consent)
- As per recommendation of Avamys™ (Fluticasone furoate) prescribing information
Exclusion criteria:
- Patients with known hypersensitivity to Fluticasone furoate or any component of the preparation
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
2013-08-01
Actual study completion date
2013-08-01
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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