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

Nasal Congestion Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02275364
• Other study ID #: 202178
• Status: Completed
• Phase: N/A
• First received: May 22, 2014
• Last updated: May 28, 2015
• Start date: August 2013
• Est. completion date: October 2013

Study information

• Verified date: May 2015
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Participants with a self-rating of at least 3 to 8 for nasal congestion on the numerical rating scale

2. Participants with a nasal congestion frequency score of 1, 2, 3 or 4.

Exclusion Criteria:

1. Evidence of obstructive nasal polyps, nasal tract structural malformations, visible open sores, sunburn, irritation, eczema or chronic skin condition on the face or nose

2. 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

3. Known or suspected intolerance or hypersensitivity to the study materials.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Nasal Congestion

Intervention

Device:
• Test strip
Class I device for the application to the nose to facilitate better air flow through the nose
• 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.

Locations

Country	Name	City	State
United Kingdom	Imanova Centre for Imaging Sciences	London

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	Anatomical Measures: Volume (Multiple Volume Reading)	Determination of averaged volume reading during the MRI (Average of 8 sub-regions)	Upto 2.5 hours	No
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No