To Characterize the Performance of the Nasal Dilator Strip in Lowering Nasal Resistance During Sleep, Promoting Nasal Route Breathing and Reducing the Signs and Symptoms of Sleep Disordered Breathing in a Group of Chronic Nocturnal Nasal Congestion Sufferers Who Report Trouble With Their Sleep.

NCT03105297 | Completed Phase 2 Results

• 1 other identifier: 202203
• Study Type: interventional
• Target: 91
• Locations: 1 country
• Sites: 1

Brief Summary

To characterize the performance of the nasal dilator strip in lowering nasal resistance during sleep, promoting nasal route breathing and reducing the signs and symptoms of sleep disordered breathing in a group of chronic nocturnal nasal congestion sufferers who report trouble with their sleep.

Conditions

Sleep Disordered Breathing; Congestion, Nasal

Keywords

Nasal dilator strip; Sleep disordered breathing

Outcome Measures

Primary Outcomes (4)

• Nasal Resistance in Sleeping State : Nasal Resistance Phase

  Nasal resistance of the participants with and without strip was measured in sleeping state using a nasal mask and a flow meter to obtain a trans-nasal pressure difference and nasal flow by continuous recording over the 2 nights \[on Day 30 (Visit 5) and Day 31 (Visit 6), cumulatively\], of the nasal resistance phase.

  upto 2 days

• Area at Minimum Cross Sectional Area 1 (MCA1) : Baseline Phase

  Minimum cross sectional area 1 (MCA1) in the first 3 cm of the nasal cavity behind the nostril (0-3 cm), considered to be the area of the nasal valve and the distance from the nares of this restriction. MCA 1 was measured with an Acoustic Rhinometer at Day 1 (baseline phase) before and after Nasal dilator strip application.

  Day 1

• Volume at Minimum Cross-sectional Area 1 (MCA1) : Baseline Phase

  Volume of the first 3 cm of the nasal cavity behind the nostril (0-3 cm2). Volume at MCA1 was measured with an Acoustic Rhinometer at Day 1 before and after Nasal dilator strip application.

  Day 1

• Nasal Resistance by Posterior Rhinomanometry : Baseline Phase

  Nasal resistance was measured on Day 1, by a modified method of posterior rhinomanometry in awake and seated position. Using posterior rhinomanometry, the transnasal pressure difference was measured between the nasopharynx and the external nares. The technique measures the difference in transnasal pressure that drives the flow of air through the nasal cavities.

  Day 1

Secondary Outcomes (22)

• Total Score of Composite Functional Outcomes of Sleep Questionnaire (FOSQ) : Active Phase

  Day 29

• Global Self Assessment Score : Active Phase

  Day 29

• Total Epworth Sleepiness Scale Score (ESS) : Active Phase

  Day 29

• Number of Snores Per Hour : Baseline, Active and Nasal Resistance Phase

  Day 1, Day 8, Day 29, Day 30 and Day 31

• Snoring Percent of Sleep Time : Baseline, Active and Nasal Resistance Phase

  Day 1, Day 8, Day 29, Day 30 and Day 31

Study Arms (3)

All participants (Baseline phase)

EXPERIMENTAL

All the participants were applied nasal dilator strip during the sleep laboratory night on Day 1.

Device: Prototype nasal dilator strip

All Participants (Active Phase)

EXPERIMENTAL

All the participants wore nasal dilator strip over a 1 month in-home use period and returned for sleep laboratory nights after 7 (Day 8) and 28 days (Day 29) of treatment

Device: Prototype nasal dilator strip

All Participants (Nasal Resistance Phase)

EXPERIMENTAL

The participants were randomized to receive a sequence of either 'strip'/' no strip' or 'no strip'/'strip' on 2 sleep laboratory nights (on Day 30 and Day 31) based on the randomization schedule

Device: Prototype nasal dilator strip; Other: No strip

Interventions

Prototype nasal dilator strip DEVICE

External Prototype Nasal Dilator strip. GSK prototype nasal dilator AB 2R11. All the participants used nasal dilator strip throughout the active phase of the study (Day 1 to Day 28). Followed by that all the participants used the nasal strip on Day 29 or 30 in Nasal resistance phase of the study as per their randomization sequence.

All Participants (Active Phase); All Participants (Nasal Resistance Phase); All participants (Baseline phase)

No strip OTHER

All Participants (Nasal Resistance Phase)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Nostril types I and II (Inter-axial angle below 41 degrees = type I; inter-axial angle from 41 to 70 degrees = type II)
• Nasal Congestion: Have chronic nocturnal nasal congestion ('always or almost always') for at least the last year.
• Sleep: Reports trouble with sleep

You may not qualify if:

• Allergy/Intolerance: Known or suspected intolerance or hypersensitivity to latex. Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds), allergy or atopic reaction to adhesive bandages or latex.
• Subject has a chronic skin condition or eczema on the face or nose.
• Subject has visible open sores, sunburn, irritation on the face or nose immediately prior to treatment.
• Subject has severe obstructive sleep apnea/hypopnea syndrome with an AHI score \<30 events/hour at the Baseline visit.
• Subject has had a diagnosis of another major sleep disorder (i.e. primary insomnia, i.e. regularly sleeping less than 6 hours per night, sleep insufficiency, i.e. sleeping \>2 hours more on non-work days as compared to work days, narcolepsy, or periodic limb movement disorder).
• Subject has a non-typical sleep schedule (e.g. shift-work).
• Subject plans travel involving time-zone changes during the study period.
• Subject takes medication known to have a significant effect on sleep. Use of any substance with psychotropic effects or properties known to affect sleep/wake, including but not limited to: neuroleptics, morphine/opioid derivatives, sedative antihistamines, stimulants, antidepressants, clonidine, barbiturates, anxiolytics, thalidomide, hypnotics and sedatives. Use of over the counter sleep promoting agents including diphenhydramine, doxylamine, tryptophan, valerian root, kava kava, melatonin, St John's Wort and Alluna. Use of over the counter alertness aids including caffeine and guarana.
• Subject currently uses any topical nasal decongestants (nasal sprays, drops, etc). Subject must have discontinued use of topical decongestants at least 7 days prior Baseline.
• Subject is experiencing an acute upper respiratory tract infection at during qualification phase and at Baseline visit.
• Subject abuses alcohol (regularly drinks more than 3 drinks per day) or has a recent history (within last 2 years) of substance or alcohol abuse. Regular consumption of xanthine-containing beverages (i.e. tea, coffee, or cola) comprising usually more than 5 cups or glasses per day.
• Subject has a positive drug of abuse screening result.
• Subject has severe, unstable disease states (e.g. myocardial infarction, congestive heart failure, diabetes, cirrhosis, cancer, epilepsy, or stroke), pain syndromes, (e.g. fibromyalgia) or any medical or surgical condition that places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study or who in the judgement of the principal investigator would not be suitable for entry into this study.
• Severe nasal obstruction caused by structural abnormality that renders the subject unsuitable for the study in the opinion of the investigator, i.e. nasal polyps, severe deviated septum.
• Subject is unwilling to be videotaped or recorded during the PSG studies.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

Westmead Hospital

Westmead, New South Wales, 2145, Australia

Location

Related Publications (1)

• Wheatley JR, Amis TC, Lee SA, Ciesla R, Shanga G. Objective and Subjective Effects of a Prototype Nasal Dilator Strip on Sleep in Subjects with Chronic Nocturnal Nasal Congestion. Adv Ther. 2019 Jul;36(7):1657-1671. doi: 10.1007/s12325-019-00980-z. Epub 2019 May 22.

  PMID: 31119695 DERIVED

MeSH Terms

Conditions

Sleep Apnea Syndromes; Nasal Obstruction

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Nose Diseases; Airway Obstruction; Respiratory Insufficiency; Otorhinolaryngologic Diseases

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

GSKClinicalSupportHD@gsk.com

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 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This study consisted of 3 phases baseline and active phase in which participants used the nasal dilator strip followed by 2 nights cross over nasal resistance phase in which participants were randomized to receive a sequence of strip/no strip or no strip/strip.

Study Record Dates

• First Submitted: April 5, 2017
• First Posted: April 7, 2017
• Study Start: September 25, 2009
• Primary Completion: August 10, 2010
• Study Completion: August 10, 2010
• Last Updated: July 26, 2019
• Results First Posted: July 26, 2019

Record last verified: 2019-05

Locations

AU (1)