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

NCT02275364 | Completed Phase 4 Results

• 1 other identifier: 202178
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Nasal Congestion

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (3)

• Breathing-related Cortical Activity (Blood Oxygen Level Dependent- Resting State)

  Upto 2.5 hours

• Verbal Numerical Response (VNR): Change From Baseline to Immediately After Strip Application and 30 Minutes Post Application

  Upto 30 minutes

• VNR: Change From Baseline to 20 Minutes After Decongestant Administration, and Post Application of the Marketed Nasal Strip After Decongestant Administration

  Upto 2 hours

Study Arms (2)

Test nasal strip

EXPERIMENTAL

Marketed Nasal Strip to be applied for up to two hours, and during the third scanning session for approximately 20 minutes.

Device: Test strip; Other: Nasal spray

Placebo nasal strip

PLACEBO COMPARATOR

Placebo nasal strip to be applied for up to two hours in either of the first two scans only.

Device: Placebo strip; Other: Nasal spray

Interventions

Test strip DEVICE

Class I device for the application to the nose to facilitate better air flow through the nose

Test nasal strip

Placebo strip DEVICE

Placebo strip

Placebo nasal strip

Nasal spray OTHER

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

Placebo nasal strip; Test nasal strip

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

Imanova Centre for Imaging Sciences

London, W12 0NN, United Kingdom

Location

MeSH Terms

Conditions

Nasal Obstruction

Interventions

Nasal Sprays

Condition Hierarchy (Ancestors)

Nose Diseases; Respiratory Tract Diseases; Airway Obstruction; Respiratory Insufficiency; Respiration Disorders; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Aerosols; Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2014
• First Posted: October 27, 2014
• Study Start: August 5, 2013
• Primary Completion: October 30, 2013
• Study Completion: October 30, 2013
• Last Updated: August 2, 2017
• Results First Posted: January 26, 2015

Record last verified: 2017-06

Locations

GB (1)