Last updated: 01/12/2022 07:20:11
Questionnaire-based, Post-Market Clinical Follow-Up (PMCF) Study to Assess the Safety and Performance of Otrisal 0.74 percent (%) Sodium Chloride (NaCl) Metered-Dose Spray (MDS)
GSK study ID
218234
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
Trial overview
Official title: Observational, Questionnaire-based, Post-Market Clinical Follow-Up (PMCF) Study for Otrisal 0.74% NaCl Metered-Dose Spray
Trial description: The purpose of this study is to further confirm the safety and performance of Otrisal 0.74% NaCl MDS post- Certification Europe (CE) Mark for its indicated populations.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Proportion of Participants who Reported Adverse Event (AE) or Device Malfunction in Previous 6 Months
Timeframe: 6 months prior to completing the online questionnaire
Percentage of Participants Reporting Satisfaction
Timeframe: 6 months prior to completing the online questionnaire
Secondary outcomes:
Not applicable
Interventions:
Device: Otrisal 0.74% NaCl MDS
Enrollment:
637
Observational study model:
Ecologic or Community
Primary completion date:
2021-30-12
Time perspective:
Retrospective
Clinical publications:
Not applicable
Medical condition
Common cold
Product
sodium chloride
Collaborators
Not applicable
Study date(s)
December 2021 to December 2021
Type
Observational
Phase
4
Participation criteria
Sex
Female & Male
Age
0 - 0 Not applicable
Accepts healthy volunteers
No
- Participant (parent/guardian/caregiver [refers to persons over the age of 18 years old] thereof) is reasonably able to operate an electronic resource (for example, access to computer, smartphone or tablet and sufficient Internet access to connect to study platform) and complete the questionnaire in an electronic format.
- Adults (refers to persons over the age of 18 years old) who have administered or supervised the use of the medical device in infants/babies (including babies less than [<]2 weeks old) or children (parents/guardians/caregiver thereof) in the previous 6 months.
- Participant (parent/guardian/caregiver thereof) is unable to operate an electronic resource (for example, access to computer, smartphone or tablet and sufficient Internet access to connect to study platform) and complete the questionnaire in an electronic format.
- Participant (adult/parent/guardian/caregiver thereof) has not used or supervised the use of Otrisal 0.74% NaCl MDS in the previous 6 months.
Inclusion and exclusion criteria
Inclusion criteria:
- Participant (parent/guardian/caregiver [refers to persons over the age of 18 years old] thereof) is reasonably able to operate an electronic resource (for example, access to computer, smartphone or tablet and sufficient Internet access to connect to study platform) and complete the questionnaire in an electronic format.
- Adults (refers to persons over the age of 18 years old) who have administered or supervised the use of the medical device in infants/babies (including babies less than [<]2 weeks old) or children (parents/guardians/caregiver thereof) in the previous 6 months.
- Adults (including pregnant and breastfeeding women) who have used the medical device in the previous 6 months.
Exclusion criteria:
- Participant (parent/guardian/caregiver thereof) is unable to operate an electronic resource (for example, access to computer, smartphone or tablet and sufficient Internet access to connect to study platform) and complete the questionnaire in an electronic format.
- Participant (adult/parent/guardian/caregiver thereof) has not used or supervised the use of Otrisal 0.74% NaCl MDS in the previous 6 months.
Trial location(s)
Study documents
No study documents available.
Results overview
No study documents available
Recruitment status
Finalized
Actual primary completion date
2021-30-12
Actual study completion date
2021-30-12
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