Trial Outcomes & Findings for Drug Utilization Study for Pirinase Hayfever Relief (NCT NCT02856282)
NCT ID: NCT02856282
Last Updated: 2019-06-24
Results Overview
Participants who answered the question, 'What is your age?', were evaluated to provide the data for this outcome measure.
COMPLETED
46 participants
2 allergy seasons (up to a maximum of 2 years)
2019-06-24
Participant Flow
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.
A total of 72 participants were screened out of whom only 46 answered the survey. Rest 31 were screen failures.
Participant milestones
| Measure |
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).
|
|---|---|
|
Overall Study
STARTED
|
46
|
|
Overall Study
COMPLETED
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45
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
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).
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|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
Drug Utilization Study for Pirinase Hayfever Relief
Baseline characteristics by cohort
| Measure |
Pirinase Hayfever Relief for Adults 0.05% Nasal Spray
n=46 Participants
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).
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|---|---|
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Age, Continuous
|
42.3 Years
STANDARD_DEVIATION 14.39 • n=39 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=39 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=39 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=39 Participants
|
|
Race (NIH/OMB)
White
|
39 Participants
n=39 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=39 Participants
|
PRIMARY outcome
Timeframe: 2 allergy seasons (up to a maximum of 2 years)Population: Analysis population included all participants who completed the online survey.
Participants who answered the question, 'What is your age?', were evaluated to provide the data for this outcome measure.
Outcome measures
| Measure |
Pirinase Hayfever Relief for Adults 0.05% Nasal Spray
n=45 Participants
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).
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|---|---|
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Number of Participants Who Used the Test Product at Correct Age (18 Years or Older)
|
45 Participants
|
PRIMARY outcome
Timeframe: 2 allergy seasons (up to a maximum of 2 years)Population: Analysis population included all participants who completed the online survey.
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.
Outcome measures
| Measure |
Pirinase Hayfever Relief for Adults 0.05% Nasal Spray
n=45 Participants
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).
|
|---|---|
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Number of Participants Who Did Not Exceed the Correct Frequency of Use (2 Sprays Per Nostril Per Day)
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32 Participants
|
PRIMARY outcome
Timeframe: 2 allergy seasons (up to a maximum of 2 years)Population: 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.
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.
Outcome measures
| Measure |
Pirinase Hayfever Relief for Adults 0.05% Nasal Spray
n=41 Participants
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).
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|---|---|
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Number of Participants With Improved Symptoms Who Reduced the Doses to 1 Spray Per Nostril Per Day
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30 Participants
|
PRIMARY outcome
Timeframe: 2 allergy seasons (up to a maximum of 2 years)Population: 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.
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.
Outcome measures
| Measure |
Pirinase Hayfever Relief for Adults 0.05% Nasal Spray
n=23 Participants
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).
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|---|---|
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Number of Pregnant/ Breastfeeding Participants Who Consulted Physician Before Product Use
|
0 Participants
|
PRIMARY outcome
Timeframe: 2 allergy seasons (up to a maximum of 2 years)Population: 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.
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.
Outcome measures
| Measure |
Pirinase Hayfever Relief for Adults 0.05% Nasal Spray
n=4 Participants
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).
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|---|---|
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Number of Participants Who Consulted Physician if Symptoms Were Not Improved After Using Test Product for 7 Days
|
0 Participants
|
SECONDARY outcome
Timeframe: 2 allergy seasons (up to a maximum of 2 years)Population: Analysis population included all participants who completed the online survey.
Participants who answered the question, 'Do you take medicine for HIV?', were evaluated to provide the data for this outcome measure.
Outcome measures
| Measure |
Pirinase Hayfever Relief for Adults 0.05% Nasal Spray
n=45 Participants
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).
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|---|---|
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Number of Participants Who Used the Test Product and Were Not Taking a Medication for Human Immunodeficiency Virus (HIV)
|
44 Participants
|
SECONDARY outcome
Timeframe: 2 allergy seasons (up to a maximum of 2 years)Population: 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.
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.
Outcome measures
| Measure |
Pirinase Hayfever Relief for Adults 0.05% Nasal Spray
n=11 Participants
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).
|
|---|---|
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Number of Participants Who Consulted Physician When Test Product Was Used for 1 Month or More Continuously
|
3 Participants
|
Adverse Events
Pirinase Hayfever Relief for Adults 0.05% Nasal Spray
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER