Last updated: 01/17/2022 07:20:08

Questionnaire-based, PMCF Study to Assess the Safety and Performance of Prorhinel SpraysPMCF

GSK study ID
218285
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Observational, Questionnaire-based, Post-Market Clinical Follow-Up (PMCF) Study for Prorhinel Sprays (3 different nasal nozzles: Prorhinel Spray Infants-Young Children/Prorhinel Spray Infants- Children [Baby nozzle], Prorhinel Spray Children-Adults/Prorhinel Spray Adults [Regular nozzle], Prorhinel Spray Jet Tonic Adults [Jet nozzle])
Trial description: The purpose of this study is to further confirm the safety and performance of Prorhinel sprays post-European Conformity Marking (CE Mark) for its respective 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)/Side Effect (SE) or Device Malfunction (DM) 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: Prorhinel Spray Infants-Young Children/Prorhinel spray Infants-Children
  • Device: Prorhinel Spray Children-Adults/Prorhinel Spray Adults
  • Device: Prorhinel Spray Jet Tonic Adults
    • Enrollment:
    695
    Primary completion date:
    2021-30-12
    Observational study model:
    Ecologic or Community
    Time perspective:
    Prospective
    Clinical publications:
    Not applicable
    Medical condition
    Common cold
    Product
    Not applicable
    Collaborators
    Not applicable
    Study date(s)
    December 2021 to December 2021
    Type
    Observational
    Phase
    4

    Participation criteria

    Sex
    Female & Male
    Age
    Not applicable
    Accepts healthy volunteers
    No
    • Participant (adult/parent/guardian/caregiver* thereof) is reasonably able to operate an electronic resource (for example [e.g.] access to computer, smartphone or tablet and sufficient internet access to connect to study platform) and complete the questionnaire in an electronic format.
    • Infants/babies, children (parents/guardians/caregivers* thereof) or adults (including pregnant and breastfeeding women) who have been treated with/used the medical device in the previous 6 months.
    • Participant (adult/parent/guardian/caregiver* thereof) is unable to operate an electronic resource (e.g. 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 Prorhinel spray in the previous 6 months.
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Participant (adult/parent/guardian/caregiver* thereof) is reasonably able to operate an electronic resource (for example [e.g.] access to computer, smartphone or tablet and sufficient internet access to connect to study platform) and complete the questionnaire in an electronic format.
    • Infants/babies, children (parents/guardians/caregivers* thereof) or adults (including pregnant and breastfeeding women) who have been treated with/used the medical device in the previous 6 months.
    • Adults* who have supervised the use of the medical device in the previous 6 months. * Adult/guardian/caregiver refers to persons over the age of 18 years old.
    Exclusion criteria:
    • Participant (adult/parent/guardian/caregiver* thereof) is unable to operate an electronic resource (e.g. 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 Prorhinel spray in the previous 6 months. *Adult/guardian/caregiver refers to persons over the age of 18 years old.

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

    No study documents available.

    Results overview

    No study documents available

    Recruitment status
    Study complete
    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
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