Drug Utilization Study for Pirinase Hayfever Relief

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02856282

Enrollment

Registered

2016-08-04

Start date

2016-02-15

Completion date

2018-03-31

Last updated

2019-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rhinitis, Allergic, Seasonal

Brief 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).

Interventions

DRUGPirinase Hayfever Relief for Adults 0.05% Nasal Spray

Aqueous suspension of 0.05% micronised fluticasone propionate.Each actuation contains 50 micrograms of fluticasone propionate

Study design

Observational model

CASE_ONLY

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

4 Years to 65 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Number of Participants Who Did Not Exceed the Correct Frequency of Use (2 Sprays Per Nostril Per Day)	2 allergy seasons (up to a maximum of 2 years)	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.
Number of Pregnant/ Breastfeeding Participants Who Consulted Physician Before Product Use	2 allergy seasons (up to a maximum of 2 years)	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.
Number of Participants Who Consulted Physician if Symptoms Were Not Improved After Using Test Product for 7 Days	2 allergy seasons (up to a maximum of 2 years)	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.
Number of Participants Who Used the Test Product at Correct Age (18 Years or Older)	2 allergy seasons (up to a maximum of 2 years)	Participants who answered the question, 'What is your age?', were evaluated to provide the data for this outcome measure.
Number of Participants With Improved Symptoms Who Reduced the Doses to 1 Spray Per Nostril Per Day	2 allergy seasons (up to a maximum of 2 years)	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.

Secondary

Measure	Time frame	Description
Number of Participants Who Consulted Physician When Test Product Was Used for 1 Month or More Continuously	2 allergy seasons (up to a maximum of 2 years)	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.
Number of Participants Who Used the Test Product and Were Not Taking a Medication for Human Immunodeficiency Virus (HIV)	2 allergy seasons (up to a maximum of 2 years)	Participants who answered the question, 'Do you take medicine for HIV?', were evaluated to provide the data for this outcome measure.

Countries

United Kingdom

Participant flow

Recruitment details

This study was conducted in United Kingdom. Participants who purchased product took part in online survey conducted by either of 2 methods: 1- scanned a Quick Response code on product package labelling/link on the product box, 2- via an e-mail invitation (who purchased product at a Boots Pharmacy), that included a link to the survey.

Pre-assignment details

A total of 72 participants were screened out of whom only 46 answered the survey. Rest 31 were screen failures.

Participants by arm

Arm	Count
Pirinase Hayfever Relief for Adults 0.05% Nasal Spray Participants were advised to take Pirinase Hayfever Relief for Adults 0.05 percent (%) Nasal Spray (an aqueous suspension of 0.05% micronised fluticasone propionate), two sprays into each nostril once a day, preferably in the morning for at least 7 days. Participants were invited to complete the online survey if they qualified the screening and were using the product for at least 1 month. Data collection continued through 2 allergy seasons (up to a maximum of 2 years).	46
Total	46

Arm

Count

Pirinase Hayfever Relief for Adults 0.05% Nasal Spray

Participants were advised to take Pirinase Hayfever Relief for Adults 0.05 percent (%) Nasal Spray (an aqueous suspension of 0.05% micronised fluticasone propionate), two sprays into each nostril once a day, preferably in the morning for at least 7 days. Participants were invited to complete the online survey if they qualified the screening and were using the product for at least 1 month. Data collection continued through 2 allergy seasons (up to a maximum of 2 years).

Total

Withdrawals & dropouts

Period	Reason	FG000
Overall Study	Withdrawal by Subject	1

Baseline characteristics

Characteristic	Pirinase Hayfever Relief for Adults 0.05% Nasal Spray
Age, Continuous	42.3 Years STANDARD_DEVIATION 14.39
Race (NIH/OMB) American Indian or Alaska Native	0 Participants
Race (NIH/OMB) Asian	3 Participants
Race (NIH/OMB) Black or African American	1 Participants
Race (NIH/OMB) More than one race	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants
Race (NIH/OMB) White	39 Participants
Sex: Female, Male Female	23 Participants
Sex: Female, Male Male	23 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	0 / 46
other Total, other adverse events	0 / 46
serious Total, serious adverse events	0 / 46

Outcome results

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.