Regulatory Avamys PMS
This study is currently recruiting participants.
Verified May 2012 by GlaxoSmithKline
Sponsor:
GlaxoSmithKline
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01001130
First received: October 22, 2009
Last updated: May 10, 2012
Last verified: May 2012
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Purpose
Non-interventional, open-label, single group, multicentric post-marketing surveillance to monitor the safety and effectiveness of Avamys® administered in Korean patients according to the prescribing information
| Condition | Intervention |
|---|---|
|
Rhinitis, Allergic, Perennial and Seasonal |
Drug: fluticasone furoate group |
| Study Type: | Observational |
| Study Design: | Time Perspective: Prospective |
| 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 |
Resource links provided by NLM:
Further study details as provided by GlaxoSmithKline:
Primary Outcome Measures:
- Number of participants with an adverse event [ Time Frame: 2weeks ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Number of participants with a serious adverse event [ Time Frame: 2weeks ] [ Designated as safety issue: Yes ]
- Number of participants with an unexpected adverse event [ Time Frame: 2weeks ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 3000 |
| Study Start Date: | May 2010 |
| Estimated Study Completion Date: | May 2014 |
| Estimated Primary Completion Date: | May 2014 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
fluticasone furoate group
Korean patients administered fluticasone furoate according to the Prescription information
|
Drug: fluticasone furoate group
patients who are administered fluticasone furoate at least once
Other Name: according to label and physician's decision
|
Eligibility| Ages Eligible for Study: | 2 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Study Population
Patients administrated Avamys at the site
Criteria
All subjects must satisfy the following criteria at PMS entry according to KFDA PMS regulation:
- Subjects with indication in the prescribing information
- Subjects administrated Avamys® by physician's decision
- Subjects with no contraindication according to the prescribing information
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01001130
Contacts
| Contact: US GSK Clinical Trials Call Center | 877-379-3718 | GSKClinicalSupportHD@gsk.com |
Locations
| Korea, Republic of | |
| GSK Investigational Site | Recruiting |
| Seongnam-si Gyeonggi-do, Korea, Republic of, 463-707 | |
| Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
| Contact: EU GSK Clinical Trials Call Center +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
Sponsors and Collaborators
GlaxoSmithKline
Investigators
| Study Director: | GSK Clinical Trials | GlaxoSmithKline |
More Information
No publications provided
| Responsible Party: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT01001130 History of Changes |
| Other Study ID Numbers: | 113596 |
| Study First Received: | October 22, 2009 |
| Last Updated: | May 10, 2012 |
| Health Authority: | Korea: Food and Drug Administration |
Keywords provided by GlaxoSmithKline:
|
avamys Allergic Rhinitis post marketing surveillance |
Seasonal Allergic Rhinitis Perennial Allergic Rhinitis (PAR) rhinitis |
Additional relevant MeSH terms:
|
Rhinitis Rhinitis, Allergic, Perennial Nose Diseases Respiratory Tract Diseases Respiratory Tract Infections Otorhinolaryngologic Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Fluticasone |
Bronchodilator Agents Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Anti-Asthmatic Agents Respiratory System Agents Therapeutic Uses Dermatologic Agents Anti-Allergic Agents Anti-Inflammatory Agents |
ClinicalTrials.gov processed this record on May 23, 2013