Last updated: 05/15/2019 07:49:10
Drug Utilization Study for Pirinase Hayfever Relief
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
Trial overview
Official title: Drug Utilization Study for Pirinase Hayfever Relief for Adults 0.05% Nasal Spray
Trial description: 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).
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Number of consumers with 18 years of age or older
Timeframe: Baseline-2 years
Number of consumers with use of not more than 2 sprays/nostril per day
Timeframe: Baseline-2 years
Number of consumers with reduced dose of 1 spray/nostril per day if symptoms improve
Timeframe: Baseline-2 years
Number of consumers who consulted Doctor before use in pregnant or breastfeeding woman
Timeframe: Baseline-2 years
Number of consumers who consulted Doctor if symptoms do not improve after 7 days of use
Timeframe: Baseline-2 years
Secondary outcomes:
Number of consumers taking HIV medications do not use the drug
Timeframe: Baseline-2 years
Number of consumers who consulted doctor if medication is used more than 1 month continuously
Timeframe: Baseline-2 years
Interventions:
Drug: Pirinase Hayfever Relief for Adults 0.05% Nasal Spray
Enrollment:
46
Observational study model:
Case-Only
Primary completion date:
2018-31-03
Time perspective:
Retrospective
Clinical publications:
Not applicable
Medical condition
Rhinitis, Allergic, Seasonal
Product
fluticasone propionate
Collaborators
Not applicable
Study date(s)
February 2016 to March 2018
Type
Observational
Phase
4
Participation criteria
Sex
Female & Male
Age
4 - 65 years
Accepts healthy volunteers
Yes
- Participants will be required to review, and electronically sign a Participation Agreement prior to completing the online survey.
- Participants of any age may participate.
- Anyone who is directly involved with medicines such as doctors, nurses, and pharmacists.
- Participants who decline participation in the online survey
Inclusion and exclusion 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
Trial location(s)
Study documents
Statistical analysis plan
Available language(s): English
Protocol
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
No study documents available
Recruitment status
Finalized
Actual primary completion date
2018-31-03
Actual study completion date
2018-31-03
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
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