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

A Magnetic Resonance Imaging Study of Nasal Strips in Subjects With Nasal Congestion

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.

Study Overview

• Status: Completed
• Conditions: Nasal Congestion
• Intervention / Treatment: Device: Test strip; Other: Nasal spray; Device: Placebo strip

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Phase 4

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, W12 0NN
    • Imanova Centre for Imaging Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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.	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.; Device: Placebo strip; Placebo strip

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anatomical Measures : Cross Sectional Area	Determination of cross sectional area derived from examination of the nasal passages and sinuses using T1 weighted MRI scans.	Upto 2.5 hours
Functional Brain Activity: Blood Oxygen Level Dependent- Interoceptive Attention Task	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.	Upto 2.5 hours
Anatomical Measure: Volume (Single Volume Reading)	Determination of single volume reading derived from examination of the nasal passages and sinuses, during the MRI.	Upto 2.5 hours
Cerebral Blood Flow (CBF)	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.	Upto 2.5 hours
Anatomical Measures: Volume (Multiple Volume Reading)	Determination of averaged volume reading during the MRI (Average of 8 sub-regions)	Upto 2.5 hours
Functional Measure: Blood Oxygen Level Dependent- Interoceptive Attention Task (Psychophysiological Interactive Analysis)	Regional measures of functional brain activity were to be derived from a breathing-related interoceptive task.	Upto 2.5 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Breathing-related Cortical Activity (Blood Oxygen Level Dependent- Resting State)	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.	Upto 2.5 hours
Verbal Numerical Response (VNR): Change From Baseline to Immediately After Strip Application and 30 Minutes Post Application	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.	Upto 30 minutes
VNR: Change From Baseline to 20 Minutes After Decongestant Administration, and Post Application of the Marketed Nasal Strip After Decongestant Administration	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.	Upto 2 hours

Collaborators and Investigators

• Sponsor: GlaxoSmithKline

Study record dates

Study Major Dates

• Study Start (Actual): August 5, 2013
• Primary Completion (Actual): October 30, 2013
• Study Completion (Actual): October 30, 2013

Study Registration Dates

• First Submitted: May 22, 2014
• First Submitted That Met QC Criteria: October 23, 2014
• First Posted (Estimate): October 27, 2014

Study Record Updates

• Last Update Posted (Actual): August 2, 2017
• Last Update Submitted That Met QC Criteria: June 28, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: 202178