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

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 4

Conditions: Nasal Congestion

Treatments: Other: Nasal spray; Device: Placebo strip; Device: Test strip

Study type: Interventional

Funder types: Industry

Identifiers

NCT02275364

202178

Details and patient eligibility

About

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.

Enrollment: 28 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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28 participants in 2 patient groups, including a placebo group

Test nasal strip

Experimental group

Description:

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

Treatment:

Device: Test strip

Other: Nasal spray

Placebo nasal strip

Placebo Comparator group

Description:

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

Treatment:

Device: Placebo strip

Other: Nasal spray