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OpenTrials
Completed

NCT Number: NCT02856282

Drug Utilization Study for Pirinase Hayfever Relief

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).

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Key information

Age range

4 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

GSK Investigational Site

Brentford, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pirinase Hayfever Relief for Adults 0.05% Nasal Spray

Drug

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

Primary outcomes

  1. Number of Participants Who Used the Test Product at Correct Age (18 Years or Older)

    Time frame: 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.

  2. Number of Participants Who Did Not Exceed the Correct Frequency of Use (2 Sprays Per Nostril Per Day)

    Time frame: 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.

  3. Number of Participants With Improved Symptoms Who Reduced the Doses to 1 Spray Per Nostril Per Day

    Time frame: 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.

  4. Number of Pregnant/ Breastfeeding Participants Who Consulted Physician Before Product Use

    Time frame: 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.

  5. Number of Participants Who Consulted Physician if Symptoms Were Not Improved After Using Test Product for 7 Days

    Time frame: 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.

Secondary outcomes

  1. Number of Participants Who Used the Test Product and Were Not Taking a Medication for Human Immunodeficiency Virus (HIV)

    Time frame: 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.

  2. Number of Participants Who Consulted Physician When Test Product Was Used for 1 Month or More Continuously

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Aug 4, 2016
Registry last updated
Jun 24, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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