Clinical trial NCT02856282: Drug Utilization Study for Pirinase Hayfever Relief
Official title: Drug Utilization Study for Pirinase Hayfever Relief for Adults 0.05% Nasal Spray
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rhinitis, Allergic, Seasonal
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2016-08-04
Enrollment: 46
Sex: ALL
Minimum age (years): 4
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
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.

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).


Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants Who Used the Test Product at Correct Age (18 Years or Older)
timeFrame: 2 allergy seasons (up to a maximum of 2 years)
measure: Number of Participants Who Did Not Exceed the Correct Frequency of Use (2 Sprays Per Nostril Per Day)
timeFrame: 2 allergy seasons (up to a maximum of 2 years)
measure: Number of Participants With Improved Symptoms Who Reduced the Doses to 1 Spray Per Nostril Per Day
timeFrame: 2 allergy seasons (up to a maximum of 2 years)
measure: Number of Pregnant/ Breastfeeding Participants Who Consulted Physician Before Product Use
timeFrame: 2 allergy seasons (up to a maximum of 2 years)
measure: Number of Participants Who Consulted Physician if Symptoms Were Not Improved After Using Test Product for 7 Days
timeFrame: 2 allergy seasons (up to a maximum of 2 years)
Secondary outcomes:
measure: Number of Participants Who Used the Test Product and Were Not Taking a Medication for Human Immunodeficiency Virus (HIV)
timeFrame: 2 allergy seasons (up to a maximum of 2 years)
measure: Number of Participants Who Consulted Physician When Test Product Was Used for 1 Month or More Continuously
timeFrame: 2 allergy seasons (up to a maximum of 2 years)
Other outcomes:
Locations:
city: Brentford
country: United Kingdom
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
affiliation: GlaxoSmithKline (for GlaxoSmithKline; Human Genome Sciences Inc., a GSK Company; Sirtris, a GSK Company; Stiefel, a GSK Company; ViiV Healthcare)
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: