Last updated: 11/07/2018 12:28:53

Functional Magnetic Resonance Imaging (fMRI) study of Nasal strips in Nasal congestion

GSK study ID
202178
See study documents
Clinicaltrials.gov ID
NCT02275364
See results summary
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: A Magnetic Resonance Imaging Study of Nasal Strips in Subjects with Nasal Congestion
Trial description: The aim of the study is to evaluate the effect of the nasal strip (relative to the placebo strip) on the nasal passages using anatomical MRI scans and to demonstrate the effect of the strip on breathing correlated cortical activity, using interoceptive fMRI task and analysis techniques derived from physiological data collected during scanning.
Primary purpose:
Basic Science
Trial design:
Crossover Assignment
Masking:
Single (Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:

Anatomical Measures : Cross Sectional Area

Timeframe: Upto 2.5 hours

Functional brain activity: Blood Oxygen Level Dependent- Interoceptive Attention task

Timeframe: Upto 2.5 hours

Anatomical Measure: Volume (Single volume reading)

Timeframe: Upto 2.5 hours

Cerebral Blood Flow (CBF)

Timeframe: Upto 2.5 hours

Anatomical Measures: Volume (Multiple Volume Reading)

Timeframe: Upto 2.5 hours

Functional Measure: Blood Oxygen Level Dependent- Interoceptive Attention task (Psychophysiological interactive analysis)

Timeframe: Upto 2.5 hours

Secondary outcomes:

Breathing-related cortical activity (Blood Oxygen Level Dependent- Resting State)

Timeframe: Upto 2.5 hours

Verbal Numerical Response (VNR): Change from baseline to immediately after strip application and 30 minutes post application

Timeframe: Upto 30 minutes

VNR: Change from baseline to 20 minutes after Decongestant administration, and post application of the Marketed Nasal Strip after Decongestant administration

Timeframe: Upto 2 hours

Interventions:
  • Device: Test strip
  • Device: Placebo strip
  • Other: Nasal spray
    • Enrollment:
    28
    Primary completion date:
    2013-30-10
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Laryngoscope. 2016 Oct;126(10):2205-11. doi: 10.1002/lary.25906. Epub 2016 Feb 10
    Medical condition
    Nasal Congestion
    Product
    oxymetazoline
    Collaborators
    Not applicable
    Study date(s)
    August 2013 to October 2013
    Type
    Interventional
    Phase
    4

    Participation criteria

    Sex
    Female & Male
    Age
    18+ years
    Accepts healthy volunteers
    Yes
    • Participants with a self-rating of at least 3 to 8 for nasal congestion on the numerical rating scale
    • Participants with a nasal congestion frequency score of 1, 2, 3 or 4.
    • Evidence of obstructive nasal polyps, nasal tract structural malformations, visible open sores, sunburn, irritation, eczema or chronic skin condition on the face or nose
    • Use of any medications like nasal decongestant, alpha adrenergic drugs, glucocorticoids and any current treatment which in the opinion of the investigator will affect nasal congestion
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Participants with a self-rating of at least 3 to 8 for nasal congestion on the numerical rating scale
    • Participants with a nasal congestion frequency score of 1, 2, 3 or 4.
    Exclusion criteria:
    • Evidence of obstructive nasal polyps, nasal tract structural malformations, visible open sores, sunburn, irritation, eczema or chronic skin condition on the face or nose
    • Use of any medications like nasal decongestant, alpha adrenergic drugs, glucocorticoids and any current treatment which in the opinion of the investigator will affect nasal congestion
    • Known or suspected intolerance or hypersensitivity to the study materials.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    Imanova Centre for Imaging Sciences
    London, Not Available, United Kingdom, W12 0NN
    Status
    Study Complete
    Contact us

    Study documents

    Statistical analysis plan
    Available language(s): English
    Download document(s)
    Clinical study report
    Available language(s): English
    Download document(s)
    Scientific result summary
    Available language(s): English
    Download document(s)
    Protocol
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Results posted on ClinicalTrials.gov

    Recruitment status
    Study complete
    Actual primary completion date
    2013-30-10
    Actual study completion date
    2013-30-10

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

    Additional information
    Not applicable
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