Drug Utilization Study for Pirinase Hayfever Relief

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

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).

Study Overview

• Status: Completed
• Conditions: Rhinitis, Allergic, Seasonal
• Intervention / Treatment: Drug: Pirinase Hayfever Relief for Adults 0.05% Nasal Spray

• Study Type: Observational
• Enrollment (Actual): 46

Contacts and Locations

Study Locations

• United Kingdom
  • Brentford, United Kingdom
    • GSK Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 65 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

An all comers population (consumers who opt in at their own discretion) of approximately 1,537 consumers, will be included in this study. Age, gender, and social backgrounds will be allowed to fall out naturally.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Pirinase Hayfever Relief for Adults 0.05% Nasal Spray; Two sprays into each nostril once a day, preferably in the morning. Once symptoms are under control ,a maintenance dose of one spray may be used accordingly	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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)
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)
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)

Collaborators and Investigators

• Sponsor: GlaxoSmithKline

Study record dates

Study Major Dates

• Study Start (Actual): February 15, 2016
• Primary Completion (Actual): March 31, 2018
• Study Completion (Actual): March 31, 2018

Study Registration Dates

• First Submitted: March 24, 2016
• First Submitted That Met QC Criteria: August 1, 2016
• First Posted (Estimate): August 4, 2016

Study Record Updates

• Last Update Posted (Actual): June 24, 2019
• Last Update Submitted That Met QC Criteria: March 29, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Immune System Diseases; Hypersensitivity, Immediate; Otorhinolaryngologic Diseases; Respiratory Hypersensitivity; Hypersensitivity; Nose Diseases; Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal
• Other Study ID Numbers: 205708