Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| 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. |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
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.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Brentford | United Kingdom |
A total of 72 participants were screened out of whom only 46 answered the survey. Rest 31 were screen failures.
This study was conducted in United Kingdom. Participants who purchased product took part in online survey conducted by either of 2 methods: 1- scanned a Quick Response code on product package labelling/link on the product box, 2- via an e-mail invitation (who purchased product at a Boots Pharmacy), that included a link to the survey.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Pirinase Hayfever Relief for Adults 0.05% Nasal Spray | Participants were advised to take Pirinase Hayfever Relief for Adults 0.05 percent (%) Nasal Spray (an aqueous suspension of 0.05% micronised fluticasone propionate), two sprays into each nostril once a day, preferably in the morning for at least 7 days. Participants were invited to complete the online survey if they qualified the screening and were using the product for at least 1 month. Data collection continued through 2 allergy seasons (up to a maximum of 2 years). |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Analysis population included a total of 46 participants who initiated the online survey and no participant was excluded from baseline analysis.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Pirinase Hayfever Relief for Adults 0.05% Nasal Spray | Participants were advised to take Pirinase Hayfever Relief for Adults 0.05 percent (%) Nasal Spray (an aqueous suspension of 0.05% micronised fluticasone propionate), two sprays into each nostril once a day, preferably in the morning for at least 7 days. Participants were invited to complete the online survey if they qualified the screening and were using the product for at least 1 month. Data collection continued through 2 allergy seasons (up to a maximum of 2 years). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Analysis population included all participants who completed the online survey. | Posted | Count of Participants | Participants | 2 allergy seasons (up to a maximum of 2 years) |
|
2 calendar years from the date of screening
Adverse events were not prompted in this study but a reference to the yellow card scheme for reporting of side effects was included at the end of the survey.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pirinase Hayfever Relief for Adults 0.05% Nasal Spray | Participants were advised to take Pirinase Hayfever Relief for Adults 0.05 percent (%) Nasal Spray (an aqueous suspension of 0.05% micronised fluticasone propionate), two sprays into each nostril once a day, preferably in the morning for at least 7 days. Participants were invited to complete the online survey if they qualified the screening and were using the product for at least 1 month. Data collection continued through 2 allergy seasons (up to a maximum of 2 years). |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 | GSKClinicalSupportHD@gsk.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | May 3, 2018 | Mar 29, 2019 | SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol | Mar 8, 2016 | Mar 29, 2019 | Prot_001.pdf |
Not provided
| ID | Term |
|---|---|
| D006255 | Rhinitis, Allergic, Seasonal |
| ID | Term |
|---|---|
| D065631 | Rhinitis, Allergic |
| D012220 | Rhinitis |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D059085 | Nasal Sprays |
| ID | Term |
|---|---|
| D000336 | Aerosols |
| D003102 | Colloids |
| D045424 | Complex Mixtures |
| D004304 | Dosage Forms |
| D004364 |
Not provided
Not provided
Not provided
Not provided
Not provided
| 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. |
| 2 allergy seasons (up to a maximum of 2 years) |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
|
|
| Primary | 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. | Analysis population included all participants who completed the online survey. | Posted | Count of Participants | Participants | 2 allergy seasons (up to a maximum of 2 years) |
|
|
|
| Primary | 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. | 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. | Posted | Count of Participants | Participants | 2 allergy seasons (up to a maximum of 2 years) |
|
|
|
| Primary | 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. | 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. | Posted | Count of Participants | Participants | 2 allergy seasons (up to a maximum of 2 years) |
|
|
|
| Primary | 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. | 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. | Posted | Count of Participants | Participants | 2 allergy seasons (up to a maximum of 2 years) |
|
|
|
| Secondary | 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. | Analysis population included all participants who completed the online survey. | Posted | Count of Participants | Participants | 2 allergy seasons (up to a maximum of 2 years) |
|
|
|
| Secondary | 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. | Analysis population included all participants (N=39) who used the test product for atleast 1 month. Here, number of participants analyzed indicates, participants who answered the question for this outcome measure. | Posted | Count of Participants | Participants | 2 allergy seasons (up to a maximum of 2 years) |
|
|
|
| 0 |
| 46 |
| 0 |
| 46 |
| 0 |
| 46 |
GSK agreements may vary with individual investigators but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| D012130 |
| Respiratory Hypersensitivity |
| D010038 | Otorhinolaryngologic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| Pharmaceutical Preparations |