Rhinitis, Allergic, Perennial and SeasonalNCT01001130
Regulatory AVAMYS Nasal Spray PMS
An observational study of Rhinitis, Allergic, Perennial and Seasonal, run by GlaxoSmithKline at 1 site in South Korea.
Trial summary
Non-interventional, open-label, single group, multicentric post-marketing surveillance to monitor the safety and effectiveness of AVAMYS nasal spray administered in Korean patients according to the prescribing information. AVAMYS is a registered trademark of the GSK group of companies. Read more about this study
- Who is it for?
- Ages 2 years and older
- Conditions the study is for
- Rhinitis, Allergic, Perennial and Seasonal
- What is being tested?
- fluticasone furoate group
- How many people
- 3,244 participants
- Where
- 1 siteSouth Korea
- Study dates
- May 2010to May 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients administrated AVAMYS nasal spray at the site
All subjects must satisfy the following criteria.
- Subject who is treated with AVAMYS nasal spray for the first time.
- Subject who is treated due to symptoms of seasonal and perennial allergic rhinitis in adults and children ≥2 years.
- Subject who is considered to follow the PMS protocol by an investigator.
- Subject who is contactable via telephone.
- Subject who is treated with AVAMYS nasal spray according to its prescribing information.
As considering the characteristic of the observational post marketing surveillance, the exclusion criteria is not strict. All investigators should prescribe AVAMYS nasal spray according to prescribing information which approved in Korea.
All subjects must not satisfy the following criteria.
- Subject who has hypersensitivity to its ingredients.
- As corticosteroids can slow the healing of wounds, if a subject who has surgery on his/her nose recently, or has a sore in his/her nose, or if his/her nose has been injured, the subject does not use AVAMYS nasal spray until his/her nose has healed.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
GSK Investigational Site
Seongnam-si Gyeonggi-do, 463-707
About this study
Official title: An Open Label, Multi-centre, Non-interventional Post-marketing Surveillance (PMS) to Monitor the Safety and Effectiveness of Avamys® Administered in Korean Patients According to the Prescribing Information
Non-interventional, open-label, single group, multicentric post-marketing surveillance to monitor the safety and effectiveness of AVAMYS nasal spray administered in Korean patients according to the prescribing information.
AVAMYS is a registered trademark of the GSK group of companies.
- Being tested
- fluticasone furoate group
- Keywords
- avamys, Allergic Rhinitis, post marketing surveillance, Seasonal Allergic Rhinitis, Perennial Allergic Rhinitis (PAR)
- Medical subject headings
- Rhinitis, Rhinitis, Allergic, Rhinitis, Allergic, Seasonal, Rhinitis, Allergic, Perennial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fluticasone furoate groupDrug
Also called according to label and physician's decision
patients who are administered fluticasone furoate at least once
| Study group | Role | What they receive |
|---|---|---|
| fluticasone furoate group | Korean patients administered fluticasone furoate according to the Prescription information Receives: Drug: fluticasone furoate group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with an adverse event
Number of participants with an adverse event
Measured: 2 weeks
Secondary outcomes (3)
Number of participants with a serious adverse event
Number of participants with a serious adverse event
Measured: 2 weeks
Number of participants with an unexpected or expected adverse drug reaction
Number of participants with an unexpected or expected adverse drug reaction
Measured: 2 weeks
Effectiveness after AVAMYS nasal spray administration
Effectiveness after AVAMYS nasal spray administration
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2009 (estimated)
- Study startMay 2010
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rhinitis, Allergic, Perennial and SeasonalStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 3,244 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01001130
- Sponsor's protocol ID
- 113596
- Status last verified
- Jun 2014
- First submitted
- 22 Oct 2009
- Last updated
- 30 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Multi-centre, Non-interventional Post-marketing Surveillance (PMS) to Monitor the Safety and Effectiveness of Avamys® Administered in Korean Patients According to the Prescribing Information
- ClinicalTrials.gov ID
- NCT01001130
- Acronym / sponsor ID
- 113596
- Keywords
- avamys, Allergic Rhinitis, post marketing surveillance, Seasonal Allergic Rhinitis, Perennial Allergic Rhinitis (PAR)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,244 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- May 2010
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 23 Oct 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Non-interventional, open-label, single group, multicentric post-marketing surveillance to monitor the safety and effectiveness of AVAMYS nasal spray administered in Korean patients according to the prescribing information.
AVAMYS is a registered trademark of the GSK group of companies.
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| fluticasone furoate group | – | Drug: fluticasone furoate groupKorean patients administered fluticasone furoate according to the Prescription information |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients administrated AVAMYS nasal spray at the site
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fluticasone furoate groupAlso: according to label and physician's decisionpatients who are administered fluticasone furoate at least once | Drug | fluticasone furoate group |
Primary outcome
Number of participants with an adverse event
Time frame: 2 weeks
Number of participants with an adverse event
3 secondary outcomes
Number of participants with a serious adverse event
Time frame: 2 weeks
Number of participants with an unexpected or expected adverse drug reaction
Time frame: 2 weeks
Effectiveness after AVAMYS nasal spray administration
Time frame: 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rhinitis, Allergic, Perennial and Seasonal, run by GlaxoSmithKline at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with an adverse event (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2014.