Rhinitis, Allergic, SeasonalNCT02856282

Drug Utilization Study for Pirinase Hayfever Relief

An observational study of Rhinitis, Allergic, Seasonal, run by GlaxoSmithKline at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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). Read more about this study

Who is it for?: Ages 4 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Rhinitis, Allergic, Seasonal
What is being tested?: Pirinase Hayfever Relief for Adults 0.05% Nasal Spray
How many people: 46 participants
Where: 1 siteUnited Kingdom
Study dates: 15 Feb 2016to 31 Mar 2018
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 4 to 65 years
All sexes
Healthy volunteers accepted
Child, Adult, Older adult

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.

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

GSK Investigational Site
Brentford

Other trials in United Kingdom

About this study

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

Conditions: Rhinitis, Allergic, Seasonal
Being tested: Pirinase Hayfever Relief for Adults 0.05% Nasal Spray
Medical subject headings: Rhinitis, Allergic, Seasonal

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Pirinase Hayfever Relief for Adults 0.05% Nasal SprayDrug
Aqueous suspension of 0.05% micronised fluticasone propionate.Each actuation contains 50 micrograms of fluticasone propionate

Study groups in NCT02856282
Study group	Role	What they receive
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 Receives: Drug: Pirinase Hayfever Relief for Adults 0.05% Nasal Spray

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)
Participants who answered the question, 'Do you take medicine for HIV?', were evaluated to provide the data for this outcome measure.
Measured: 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.
Measured: 2 allergy seasons (up to a maximum of 2 years)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Feb 201631 Mar 2018

First posted4 Aug 2016 (estimated)
Study start15 Feb 2016
Primary completion31 Mar 2018
Study completion31 Mar 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Rhinitis, Allergic, SeasonalStudies of the same condition, open and under way.
More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Case only
Time perspective: Retrospective
Enrolment: 46 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02856282
Sponsor's protocol ID: 205708
Status last verified: Mar 2019
First submitted: 24 Mar 2016
Last updated: 24 Jun 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 1
Safety, Tolerability And Pharmacodynamics of DM-101PX in Birch Pollen Allergy
Birch Pollen Allergy
Enrolling by invitationObservational study
Identification of Allergen-reactive Antibodies in the Blood of Pollen Allergic Patients
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Active, not recruitingPhase 3
A Clinical Study Evaluating the Efficacy and Safety of SHR-1819 Injection in Patients With Seasonal Allergic Rhinitis
Seasonal Allergic Rhinitis
RecruitingObservational study
Investigating Nasal and Ocular Immune Response to Conjunctival Allergen Exposure
Allergic Rhinoconjunctivitis
Recruiting
Evaluation of the Efficacy, Safety, and Tolerability of PL-14 Allergy Blocker Compared to Saline Spray in Patients With Seasonal Allergic Rhinitis
Seasonal Allergic Rhinitis (SAR), Allergic Rhinitis

All Rhinitis, Allergic, Seasonal trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Drug Utilization Study for Pirinase Hayfever Relief for Adults 0.05% Nasal Spray
ClinicalTrials.gov ID: NCT02856282
Acronym / sponsor ID: 205708
Conditions: Rhinitis, Allergic, Seasonal
Study type: Observational
Recruitment status: Completed
Enrolment: 46 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 15 Feb 2016 (actual)
Primary completion: 31 Mar 2018 (actual)
Study completion: 31 Mar 2018 (actual)
First posted: 4 Aug 2016 (estimated)
Results: Posted 24 Jun 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Case only
Time perspective: Retrospective
Number of arms: 1

Arm	Type	Receives
Pirinase Hayfever Relief for Adults 0.05% Nasal Spray	–	Drug: Pirinase Hayfever Relief for Adults 0.05% Nasal SprayTwo 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

Who may qualify

Ages: 4 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult, Older adult
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.

Key inclusion criteria (4 listed)

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

Key exclusion criteria (2 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Pirinase Hayfever Relief for Adults 0.05% Nasal SprayAqueous suspension of 0.05% micronised fluticasone propionate.Each actuation contains 50 micrograms of fluticasone propionate	Drug	Pirinase Hayfever Relief for Adults 0.05% Nasal Spray

Primary outcome

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.
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.
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.
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.
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.

2 secondary outcomes

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)
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)

Results and safety

Results posted to the registry on 24 Jun 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Pirinase Hayfever Relief for Adults 0.05% Nasal Spray	46	45

Primary outcome: 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). Count of participants. Unit: Participants

Measure	Pirinase Hayfever Relief for Adults 0.05% Nasal Spray n = 45
Value	45

Population analysed: Analysis population included all participants who completed the online survey.

Primary outcome: 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). Count of participants. Unit: Participants

Measure	Pirinase Hayfever Relief for Adults 0.05% Nasal Spray n = 45
Value	32

Population analysed: Analysis population included all participants who completed the online survey.

Primary outcome: 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). Count of participants. Unit: Participants

Measure	Pirinase Hayfever Relief for Adults 0.05% Nasal Spray n = 41
Value	30

Population analysed: Analysis population included all participants who completed the online survey. Here, number of participants analyzed indicates, participants who answered the question for this outcome measure.

Primary outcome: Number of Pregnant/ Breastfeeding Participants Who Consulted Physician Before Product Use

Time frame: 2 allergy seasons (up to a maximum of 2 years). Count of participants. Unit: Participants

Measure	Pirinase Hayfever Relief for Adults 0.05% Nasal Spray n = 23
Value	0

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 2 calendar years from the date of screening. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Pirinase Hayfever Relief for Adults 0.05% Nasal Spray	0 of 46 (0%)	0 of 46 (0%)	0 of 46

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Rhinitis, Allergic, Seasonal

Not yet recruitingPhase 1
Safety, Tolerability And Pharmacodynamics of DM-101PX in Birch Pollen Allergy
Birch Pollen Allergy
Enrolling by invitationObservational study
Identification of Allergen-reactive Antibodies in the Blood of Pollen Allergic Patients
Pollen Allergy
Active, not recruitingPhase 3
A Clinical Study Evaluating the Efficacy and Safety of SHR-1819 Injection in Patients With Seasonal Allergic Rhinitis
Seasonal Allergic Rhinitis
RecruitingObservational study
Investigating Nasal and Ocular Immune Response to Conjunctival Allergen Exposure
Allergic Rhinoconjunctivitis
Recruiting
Evaluation of the Efficacy, Safety, and Tolerability of PL-14 Allergy Blocker Compared to Saline Spray in Patients With Seasonal Allergic Rhinitis
Seasonal Allergic Rhinitis (SAR), Allergic Rhinitis

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

GSK Clinical Trials study director

GlaxoSmithKline

GSK Clinical Trials study director

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

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Rhinitis, Allergic, Seasonal, run by GlaxoSmithKline at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Jun 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02856282.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2019.