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
Study complete
Study complete
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:
Enrollment:
46
Primary completion date:
2018-31-03
Observational study model:
Case-Only
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
Study complete
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
Participate in clinical trial
Access to clinical trial data by researchers
Visit website