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Regulatory AVAMYS Nasal Spray PMS

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01001130
Recruitment Status : Completed
First Posted : October 23, 2009
Last Update Posted : June 30, 2014
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Tracking Information
First Submitted Date October 22, 2009
First Posted Date October 23, 2009
Last Update Posted Date June 30, 2014
Study Start Date May 2010
Actual Primary Completion Date May 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 26, 2014)
Number of participants with an adverse event [ Time Frame: 2 weeks ]
Number of participants with an adverse event
Original Primary Outcome Measures
 (submitted: October 22, 2009)
The primary objective of this PMS is to investigate adverse events of AVAMYS® Nasal Spray(NS) in Korean patients with SAR or PAR [ Time Frame: Every adverse event which occur after visit 1 will be collected ]
Change History
Current Secondary Outcome Measures
 (submitted: June 26, 2014)
  • Number of participants with a serious adverse event [ Time Frame: 2 weeks ]
    Number of participants with a serious adverse event
  • Number of participants with an unexpected or expected adverse drug reaction [ Time Frame: 2 weeks ]
    Number of participants with an unexpected or expected adverse drug reaction
  • Effectiveness after AVAMYS nasal spray administration [ Time Frame: 2 weeks ]
    Effectiveness after AVAMYS nasal spray administration
Original Secondary Outcome Measures
 (submitted: October 22, 2009)
The secondary objectives are to identify any unexpected adverse events and serious adverse events, and to evaluate efficacy after AVAMYS® NS administration in Korean patients with SAR or PAR. [ Time Frame: Every adverse event which occur after Visit 1 will be collected ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Regulatory AVAMYS Nasal Spray PMS
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
Brief 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.

Detailed Description Not Provided
Study Type Observational
Study Design Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Patients administrated AVAMYS nasal spray at the site
Condition Rhinitis, Allergic, Perennial and Seasonal
Intervention Drug: fluticasone furoate group
patients who are administered fluticasone furoate at least once
Other Name: according to label and physician's decision
Study Groups/Cohorts fluticasone furoate group
Korean patients administered fluticasone furoate according to the Prescription information
Intervention: Drug: fluticasone furoate group
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: June 26, 2014)
3244
Original Estimated Enrollment
 (submitted: October 22, 2009)
3000
Actual Study Completion Date May 2014
Actual Primary Completion Date May 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria

All subjects must satisfy the following criteria.

  1. Subject who is treated with AVAMYS nasal spray for the first time.
  2. Subject who is treated due to symptoms of seasonal and perennial allergic rhinitis in adults and children ≥2 years.
  3. Subject who is considered to follow the PMS protocol by an investigator.
  4. Subject who is contactable via telephone.
  5. 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.

  1. Subject who has hypersensitivity to its ingredients.
  2. 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 2 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number NCT01001130
Other Study ID Numbers 113596
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party GlaxoSmithKline
Study Sponsor GlaxoSmithKline
Collaborators Not Provided
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
PRS Account GlaxoSmithKline
Verification Date June 2014