Drug Utilization Study for Pirinase Hayfever Relief

Study Overview
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Brief Summary
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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).

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

Conditions
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Rhinitis, Allergic, Seasonal

Intervention / Treatment
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* Drug: Pirinase Hayfever Relief for Adults 0.05% Nasal Spray


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pirinase Hayfever Relief for Adults 0.05% Nasal Spray<br>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<br>* Aqueous suspension of 0.05% micronised fluticasone propionate.Each actuation contains 50 micrograms of fluticasone propionate<br>|

What is the study measuring?
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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) |