Phase 4 N=28 Randomized Single-blind Basic Science

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

Nasal Congestion

Bottom Line

View on ClinicalTrials.gov: NCT02275364 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jan 2015

Primary outcome: Primary: Anatomical Measures : Cross Sectional Area — 133.22; 116.88; 156.48; 176.12 mm^2 — p=<0.0001

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Test strip (Device); Placebo strip (Device); Nasal spray (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: GlaxoSmithKline
Primary completion: Oct 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY Anatomical Measures : Cross Sectional Area	133.22; 116.88; 156.48; 176.12	<0.0001 sig
PRIMARY Functional Brain Activity: Blood Oxygen Level Dependent- Interoceptive Attention Task	7.39; 7.92	0.7366
PRIMARY Anatomical Measure: Volume (Single Volume Reading)	13407.42; 11732.85; 15770.79; 17680.49	0.0004 sig
PRIMARY Cerebral Blood Flow (CBF)	85.80; 86.25	0.7278
PRIMARY Anatomical Measures: Volume (Multiple Volume Reading)	1675.93; 1466.61; 1971.35; 2210.06	0.1639
PRIMARY Functional Measure: Blood Oxygen Level Dependent- Interoceptive Attention Task (Psychophysiological Interactive Analysis)	0.13; 0.12	0.4621
SECONDARY Breathing-related Cortical Activity (Blood Oxygen Level Dependent- Resting State)	0.42; 0.33; 27.57; 10.80	—
SECONDARY Verbal Numerical Response (VNR): Change From Baseline to Immediately After Strip Application and 30 Minutes Post Application	-0.46; -0.07; -1.00; -0.42	—
SECONDARY VNR: Change From Baseline to 20 Minutes After Decongestant Administration, and Post Application of the Marketed Nasal Strip After Decongestant Administration	-1.35; -1.69	—

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.

Eligibility 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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02275364). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.