Drug Utilization Study for Pirinase Hayfever Relief

NCT02856282 | Completed Results

• 1 other identifier: 205708
• Study Type: observational
• Target: 46
• Locations: 1 country
• Sites: 1

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).

Conditions

Rhinitis, Allergic, Seasonal

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (2)

• 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)

• 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)

Study Arms (1)

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

Interventions

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

Pirinase Hayfever Relief for Adults 0.05% Nasal Spray

Eligibility Criteria

• Age: 4 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Anyone who is directly involved with medicines such as doctors, nurses, and pharmacists.
• Participants who decline participation in the online survey

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Brentford, United Kingdom

Location

MeSH Terms

Conditions

Rhinitis, Allergic, Seasonal

Interventions

Nasal Sprays

Condition Hierarchy (Ancestors)

Rhinitis, Allergic; Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Aerosols; Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

GSKClinicalSupportHD@gsk.com

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

• GSK Clinical Trials

  GlaxoSmithKline (for GlaxoSmithKline; Human Genome Sciences Inc., a GSK Company; Sirtris, a GSK Company; Stiefel, a GSK Company; ViiV Healthcare)

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2016
• First Posted: August 4, 2016
• Study Start: February 15, 2016
• Primary Completion: March 31, 2018
• Study Completion: March 31, 2018
• Last Updated: June 24, 2019
• Results First Posted: June 24, 2019

Record last verified: 2019-03

Locations

GB (1)