Drug Utilization Study for Pirinase Hayfever Relief

Rhinitis, Allergic, Seasonal Clinical Trial

Official title:

Drug Utilization Study for Pirinase Hayfever Relief for Adults 0.05% Nasal Spray

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02856282
• Other study ID #: 205708
• Status: Completed
• Start date: February 15, 2016
• Est. completion date: March 31, 2018

Study information

• Verified date: March 2019
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose is to obtain real-world information on how consumers are complying with the product labelling This study will coincide with the launch of Pirinase Hayfever Relief for Adults 0.05% Nasal Spray in the United Kingdom (UK).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: March 31, 2018
• Est. primary completion date: March 31, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Years to 65 Years

Eligibility

Inclusion Criteria:

• Participants will be required to review, and electronically sign a Participation Agreement prior to completing the online survey.

• Participants of any age may participate.

• Participants who have purchased and used Pirinase Hayfever Relief for Adults 0.05% Nasal Spray for at least 7 days and are willing to participate in the online survey.

• Participants of either gender may participate

Exclusion Criteria:

• Anyone who is directly involved with medicines such as doctors, nurses, and pharmacists.

• Participants who decline participation in the online survey

Related Conditions & MeSH terms

• Rhinitis
• Rhinitis, Allergic
• Rhinitis, Allergic, Seasonal

Intervention

Drug:
• Pirinase Hayfever Relief for Adults 0.05% Nasal Spray
Aqueous suspension of 0.05% micronised fluticasone propionate.Each actuation contains 50 micrograms of fluticasone propionate

Locations

Country	Name	City	State
United Kingdom	GSK Investigational Site	Brentford

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Who Used the Test Product at Correct Age (18 Years or Older)	Participants who answered the question, 'What is your age?', were evaluated to provide the data for this outcome measure.	2 allergy seasons (up to a maximum of 2 years)
Primary	Number of Participants Who Did Not Exceed the Correct Frequency of Use (2 Sprays Per Nostril Per Day)	Participants who answered the question, 'When using Pirinase Hayfever Relief for Adults 0.05% Nasal Spray product, did you use more than 2 sprays in each nostril per day?,' were evaluated to provide the data for this outcome measure.	2 allergy seasons (up to a maximum of 2 years)
Primary	Number of Participants With Improved Symptoms Who Reduced the Doses to 1 Spray Per Nostril Per Day	Participants who answered the question, 'Did you reduce the dose to 1 dose per nostril after your symptoms improved?', were evaluated to provide the data for this outcome measure.	2 allergy seasons (up to a maximum of 2 years)
Primary	Number of Pregnant/ Breastfeeding Participants Who Consulted Physician Before Product Use	Participants who answered the question, 'Did you talk to your doctor before using Pirinase Hayfever Relief for Adults 0.05% Nasal Spray product (if consumer said yes to pregnant or breastfeeding)? ', were evaluated to provide the data for this outcome measure.	2 allergy seasons (up to a maximum of 2 years)
Primary	Number of Participants Who Consulted Physician if Symptoms Were Not Improved After Using Test Product for 7 Days	Participants who answered the question, 'Did you consult a doctor about your symptoms not improving after using Pirinase Hayfever Relief for Adults 0.05% Nasal Spray product for 7 days? ', were evaluated to provide the data for this outcome measure.	2 allergy seasons (up to a maximum of 2 years)
Secondary	Number of Participants Who Used the Test Product and Were Not Taking a Medication for Human Immunodeficiency Virus (HIV)	Participants who answered the question, 'Do you take medicine for HIV?', were evaluated to provide the data for this outcome measure.	2 allergy seasons (up to a maximum of 2 years)
Secondary	Number of Participants Who Consulted Physician When Test Product Was Used for 1 Month or More Continuously	Participants who answered the question, 'Did you consult with a doctor about continuing to use Pirinase Hayfever Relief for Adults 0.05% Nasal Spray product (if consumer answered no to symptoms improving)?', were evaluated to provide the data for this outcome measure.	2 allergy seasons (up to a maximum of 2 years)