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Functional Magnetic Resonance Imaging (fMRI) Study of Nasal Strips in Nasal Congestion

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ClinicalTrials.gov Identifier: NCT02275364
Recruitment Status : Completed
First Posted : October 27, 2014
Results First Posted : January 26, 2015
Last Update Posted : August 2, 2017
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Nasal Congestion Device: Test strip Device: Placebo strip Other: Nasal spray Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: A Magnetic Resonance Imaging Study of Nasal Strips in Subjects With Nasal Congestion
Actual Study Start Date : August 5, 2013
Actual Primary Completion Date : October 30, 2013
Actual Study Completion Date : October 30, 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: MRI Scans

Arms and Interventions
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Arm Intervention/treatment
Experimental: Test nasal strip
Marketed Nasal Strip to be applied for up to two hours, and during the third scanning session for approximately 20 minutes.
 Device: Test strip
Class I device for the application to the nose to facilitate better air flow through the nose

Other: Nasal spray
Nasal decongestant to be used on a single occasion (one spray per nostril), 20 minutes prior to commencing the third MRI scanning sessions.
Placebo Comparator: Placebo nasal strip
Placebo nasal strip to be applied for up to two hours in either of the first two scans only.
 Device: Placebo strip
Placebo strip

Other: Nasal spray
Nasal decongestant to be used on a single occasion (one spray per nostril), 20 minutes prior to commencing the third MRI scanning sessions.


Outcome Measures
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Primary Outcome Measures :
  1. Anatomical Measures : Cross Sectional Area [ Time Frame: Upto 2.5 hours ]
    Determination of cross sectional area derived from examination of the nasal passages and sinuses using T1 weighted MRI scans.

  2. Functional Brain Activity: Blood Oxygen Level Dependent- Interoceptive Attention Task [ Time Frame: Upto 2.5 hours ]
    Regional measures of functional brain activity to be derived from a breathing-related interoceptive task. This outcome measure was pre-specified to analyze effect on nasal strips on the functional brain activity without the use of nasal decongestant.

  3. Anatomical Measure: Volume (Single Volume Reading) [ Time Frame: Upto 2.5 hours ]
    Determination of single volume reading derived from examination of the nasal passages and sinuses, during the MRI.

  4. Cerebral Blood Flow (CBF) [ Time Frame: Upto 2.5 hours ]
    CBF was derived from Arterial-Spin Labelling (ASL) scans. ASL data were analysed using custom Matlab code, which fits a CBF model to the raw perfusion data, in order to derive quantitative estimates of CBF in units of ml/100g/minute. The computed CBF maps were co-registered to the subject's whole-brain T1-weighted anatomical scan (from the first scan session) in order to spatially divide the data into anatomical Regions of Interest (ROIs). The anatomical ROIs were themselves defined by nonlinear warping of a standard cytoarchitectonic atlas into the space of the subject's T1 anatomical scan, using the FMRIB Software Library tool FNIRT. CBF data were extracted for a subset of these anatomical ROIs.

  5. Anatomical Measures: Volume (Multiple Volume Reading) [ Time Frame: Upto 2.5 hours ]
    Determination of averaged volume reading during the MRI (Average of 8 sub-regions)

  6. Functional Measure: Blood Oxygen Level Dependent- Interoceptive Attention Task (Psychophysiological Interactive Analysis) [ Time Frame: Upto 2.5 hours ]
    Regional measures of functional brain activity were to be derived from a breathing-related interoceptive task.


Secondary Outcome Measures :
  1. Breathing-related Cortical Activity (Blood Oxygen Level Dependent- Resting State) [ Time Frame: Upto 2.5 hours ]

    Regional measures of breathing-related cortical activity were derived by determining Functional Connectivity and Event-related percentage signal change.

    Functional connectivity analyzes of fMRI data where spontaneous (i.e. while the participant is at rest) signal changes in one brain region are regressed against other regions, to identify regions sharing similar functional properties.

    Event-related functional magnetic resonance imaging (efMRI) detects changes in the BOLD hemodynamic response to neural activity associated with certain event. In this case, the events were pre-defined by collecting additional data during the scan; participant respiration was determined using a simple pressure-sensitive respiration belt. Events time-locked to peak inspiration and expiration were defined separately, and regressed against brain activity, showing brain regions that were more or less active during each event type.


  2. Verbal Numerical Response (VNR): Change From Baseline to Immediately After Strip Application and 30 Minutes Post Application [ Time Frame: Upto 30 minutes ]
    Participants provided their response for VNR on a scale of 0 to 10 (0 = Breathe Freely and 10 = Totally Blocked) how easy it was to breathe through nose at a given time.

  3. VNR: Change From Baseline to 20 Minutes After Decongestant Administration, and Post Application of the Marketed Nasal Strip After Decongestant Administration [ Time Frame: Upto 2 hours ]
    Participants provided their response for VNR on a scale of 0 to 10 (0 = Breathe Freely and 10 = Totally Blocked) how easy it was to breathe through nose at a given time.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02275364


Locations
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United Kingdom
Imanova Centre for Imaging Sciences
London, United Kingdom, W12 0NN
Sponsors and Collaborators
GlaxoSmithKline
Investigators
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Study Director: GSK Clinical Trials GlaxoSmithKline
More Information
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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT02275364    
Other Study ID Numbers: 202178
First Posted: October 27, 2014    Key Record Dates
Results First Posted: January 26, 2015
Last Update Posted: August 2, 2017
Last Verified: June 2017