Last updated: 04/30/2019 15:10:11
Post-Marketing Observational Study to Evaluate Safety Profile of Avamys Treatment in Chinese Patients
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: Post-Marketing Observational Study to Evaluate Safety Profile of Avamys Treatment in Chinese Patients
Trial description: Fluticasone furoate nasal spray (FFNS) is a fluorinated glucocorticosteroid that has been developed as an intranasal treatment for allergy rhinitis (AR). FFNS is currently approved in United States, European Union Member States, Japan as well as over 100 countries globally. The drug has been shown to be effective and well-tolerated in treatment of AR from clinical trial data in China and overseas. FFNS was first approved in China in June 2012 and has demonstrated a positive benefit/risk profile for Chinese population having AR. China Food and Drug Administration (CFDA) has issued Order 81 for reporting and monitoring post-marketed drugs adverse reaction, with the requirement to conduct intensive drug monitoring (IDM) on marketed new drugs within the 5 years after first approval, to further observe the new drug safety profile in clinical practice including the feature, incidence and severity of adverse reactions among patients in real life setting. To meet CFDA requirement, this phase 4 (PH4) post-marketing safety (PMS), observational, no medical intervention drug monitoring program will be carried out to proactively collect and evaluate AR Chinese population safety when using FFNS in clinical practice. PMS profile of FFNS treatment in allergy rhinitis subjects, the adverse drug reactions, and predictors of these adverse reactions will be observed in this study. The observational program will include subjects (adult and children) who have been prescribed FFNS for appropriate medical use. The maximum program duration will be 12 weeks with 3 visits. Based on the regulatory requirement, at least 3000 subjects will be enrolled in this study for intensive drug monitoring. Two hundred subjects will be enrolled from ongoing post marketing trial, and 2800 subjects will be enrolled from hospitals and pharmacies in China.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Incidence of known adverse reactions in general adult population
Timeframe: Up to 12 Weeks
Occurrence of unexpected adverse reactions in general adult population
Timeframe: Up to 12 Weeks
Incidence of known adverse reactions in children
Timeframe: Up to 12 Weeks
Occurrence of unexpected adverse reactions in children
Timeframe: Up to 12 Weeks
Secondary outcomes:
Not applicable
Interventions:
Enrollment:
3000
Primary completion date:
2018-02-05
Observational study model:
Cohort
Time perspective:
Prospective
Clinical publications:
Not applicable
Medical condition
Rhinitis, Allergic, Perennial and Seasonal
Product
fluticasone furoate
Collaborators
Mobilemd(vendor)
Study date(s)
August 2016 to May 2018
Type
Observational
Phase
4
Participation criteria
Sex
Female & Male
Age
2+ years
Accepts healthy volunteers
Not applicable
- Informed consent: Subject should provide an appropriately signed and personally dated informed consent. An appropriately signed and dated assent must be obtained from the parent/guardian if the subject is under 18 years old.
- FFNS treatment: Subjects who have been prescribed FFNS for a medically appropriate use will be included in this observational program. These include the subjects who use FFNS for the first time or who have been started FFNS previously.
- Specific information from approved product label regarding warnings, precautions, contraindications, adverse events, and other pertinent information on FFNS impacting subject eligibility.
Inclusion and exclusion criteria
Inclusion criteria:
- Informed consent: Subject should provide an appropriately signed and personally dated informed consent. An appropriately signed and dated assent must be obtained from the parent/guardian if the subject is under 18 years old.
- FFNS treatment: Subjects who have been prescribed FFNS for a medically appropriate use will be included in this observational program. These include the subjects who use FFNS for the first time or who have been started FFNS previously.
- Subject must provide reliable contact method which includes home phone or cell phone for the follow up visits.
- Subject must have the ability to comply study procedures (subject under 18 years can be assisted by his/her parent/guardian).
Exclusion criteria:
- Specific information from approved product label regarding warnings, precautions, contraindications, adverse events, and other pertinent information on FFNS impacting subject eligibility.
Trial location(s)
Study documents
Statistical analysis plan
Available language(s): English
Scientific result summary
Available language(s): English
Protocol
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
2018-02-05
Actual study completion date
2018-02-05
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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