NCT03105297

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.

Completed Phase 2 Results posted Last updated 26 July 2019

What this trial tests

Phase 2 trial testing Prototype nasal dilator strip in Sleep Disordered Breathing in 91 participants. Completed in 10 August 2010.

Timeline

25 September 2009

Primary endpoint
10 August 2010

10 August 2010

Quick facts

Lead sponsor	GlaxoSmithKline
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	basic science
Enrollment	91
Start date	25 September 2009
Primary completion	10 August 2010
Estimated completion	10 August 2010
Sites	1 location across Australia

Drugs / interventions tested

• Prototype nasal dilator strip
• No strip

Conditions studied

• Sleep Disordered Breathing — all drugs for Sleep Disordered Breathing →
• Congestion, Nasal — all drugs for Congestion, Nasal →

Sponsor

GlaxoSmithKline — full company profile →

Who can join

18 and older, any sex, with Sleep Disordered Breathing or Congestion, Nasal. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Nasal Resistance in Sleeping State : Nasal Resistance Phase Primary · upto 2 days

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.

Without strip (Day 30 and 31)

Group	Value	95% CI
All Participants (Nasal Resistance Phase)	2.658	± 2.4469

With strip (Day 30 and 31)

Group	Value	95% CI
All Participants (Nasal Resistance Phase)	2.202	± 2.5819

Area at Minimum Cross Sectional Area 1 (MCA1) : Baseline Phase Primary · Day 1

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.

Before strip application

Group	Value	95% CI
All Participants (Baseline Phase)	1.949	± 0.8520

After strip application

Group	Value	95% CI
All Participants (Baseline Phase)	2.535	± 0.8735

Volume at Minimum Cross-sectional Area 1 (MCA1) : Baseline Phase Primary · Day 1

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.

Before strip application

Group	Value	95% CI
All Participants (Baseline Phase)	4.145	± 1.2013

After strip application

Group	Value	95% CI
All Participants (Baseline Phase)	5.043	± 1.4038

Nasal Resistance by Posterior Rhinomanometry : Baseline Phase Primary · Day 1

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.

Before strip application

Group	Value	95% CI
All Participants (Baseline Phase)	4.468	± 4.7625

After strip application

Group	Value	95% CI
All Participants (Baseline Phase)	3.251	± 4.1677

Total Score of Composite Functional Outcomes of Sleep Questionnaire (FOSQ) : Active Phase Secondary · Day 29

The FOSQ was 30-item, validated psychometric instrument that assessed the impact of disorders of excessive sleepiness on functional outcomes relevant to daily behaviors and quality of life (QoL). The responses to the questionnaire were grouped according to five factors for analysis: 1) Activity Level, 2) Vigilance, 3) Intimacy and Sexual Relationships, 4) General Productivity and 5) Social Outcome. Participant used a scale of 0 to 4 to score each question of FOSQ which then grouped in above factors (where 0= I don't do this activity for other reasons, 1= Yes, extreme difficulty, 2= Yes, modera

Group	Value	95% CI
All Participants (Active Phase)	17.55	± 2.129

Global Self Assessment Score : Active Phase Secondary · Day 29

On Day 29, prior to sleep, participants were asked to rate their overall experience with the strip as compared to before they enrolled in the study: ease of breathing, staying asleep, falling back to sleep, waking up too early, number of awakenings, falling asleep, sleep quality, sleep depth, dry mouth upon awakening, morning headache, nocturia (waking up to urinate), feeling refreshed in the morning. Experience was rated on scale of -2 to 2 were: -2 = Much worse, -1 = Somewhat worse, 0 = No change, 1 = Somewhat improve, 2 = Much improved (higher score indicated improvement).

Ease of breathing

Group	Value	95% CI
All Participants (Active Phase)	1.4	± 0.68

Falling asleep

Group	Value	95% CI
All Participants (Active Phase)	0.6	± 0.78

Staying asleep

Group	Value	95% CI
All Participants (Active Phase)	0.8	± 0.76

Number of awakenings

Group	Value	95% CI
All Participants (Active Phase)	0.7	± 0.77

Falling back to sleep

Group	Value	95% CI
All Participants (Active Phase)	0.7	± 0.76

Waking up too early

Group	Value	95% CI
All Participants (Active Phase)	0.3	± 0.63

Sleep depth

Group	Value	95% CI
All Participants (Active Phase)	0.7	± 0.70

Sleep quality

Group	Value	95% CI
All Participants (Active Phase)	0.9	± 0.69

Total Epworth Sleepiness Scale Score (ESS) : Active Phase Secondary · Day 29

Participants answered the following question How likely are you to doze off or fall asleep in the following situations, in contrast to feeling just tired? 1. Sitting and reading, 2. Watching TV, 3. Sitting, inactive in a public place (e.g. a theatre or a meeting), 4. As a passenger in a car for an hour without a break, 5. Lying down to rest in the afternoon when circumstances permit, 6. Sitting and talking to someone, 7. Sitting quietly after a lunch without alcohol, and 8. In a car, while stopped for a few minutes in the traffic. Use the following scale to choose the most appropriate number f

Group	Value	95% CI
All Participants (Active Phase)	7.410	± 4.6021

Number of Snores Per Hour : Baseline, Active and Nasal Resistance Phase Secondary · Day 1, Day 8, Day 29, Day 30 and Day 31

The Investigator or designee recorded the number of snores per hour during the participant's domiciled sleep visits. Numbers of snores were recorded for all participants with strip on Day 1 (Visit 2) in baseline phase, Day 8 (Visit 3) and Day 29 (Visit 4) in active phase, and in participants with and without strip on Day 30 (Visit 5) and Day 31 (Visit 6) cumulatively, in nasal resistance phase.

Day 1

Group	Value	95% CI
All Participants	308.18	± 216.829

Day 8

Group	Value	95% CI
All Participants	299.58	± 204.598

Day 29

Group	Value	95% CI
All Participants	330.30	± 233.635

Without strip (Day 30 and 31)

Group	Value	95% CI
All Participants	317.76	± 208.098

With strip (Day 30 and 31)

Group	Value	95% CI
All Participants	324.92	± 190.559

Snoring Percent of Sleep Time : Baseline, Active and Nasal Resistance Phase Secondary · Day 1, Day 8, Day 29, Day 30 and Day 31

The Investigator or designee recorded the snoring percent (%) present in sleep time during the participant's domiciled sleep visits. Snoring % was measured for all participants with strip on Day 1 (Visit 2) in baseline phase, Day 8 (Visit 3) and Day 29 (Visit 4) in active phase, and in participants with and without strip on Day 30 (Visit 5) and Day 31 (Visit 6) cumulatively, in nasal resistance phase.

Day 1

Group	Value	95% CI
All Participants	40.33	± 27.444

Day 8

Group	Value	95% CI
All Participants	38.70	± 25.826

Day 29

Group	Value	95% CI
All Participants	42.41	± 28.974

Without strip (Day 30 and 31)

Group	Value	95% CI
All Participants	42.11	± 27.167

With strip (Day 30 and 31)

Group	Value	95% CI
All Participants	43.22	± 24.704

Average Snore Sound Intensity : Baseline, Active and Nasal Resistance Phase Secondary · Day 1, Day 8, Day 29, Day 30 and Day 31

The Investigator or designee recorded the average snore sound intensity during the participant's domiciled sleep visits. Average snore sound intensity was measured for all participants with strip on Day 1 (Visit 2) in baseline phase, Day 8 (Visit 3) and Day 29 (Visit 4) in active phase, and in participants with and without strip on Day 30 (Visit 5) and Day 31 (Visit 6) cumulatively, in nasal resistance phase

Day 1

Group	Value	95% CI
All Participants	40.67	± 6.278

Day 8

Group	Value	95% CI
All Participants	41.85	± 6.365

Day 29

Group	Value	95% CI
All Participants	44.14	± 6.730

Without strip (Day 30 and 31)

Group	Value	95% CI
All Participants	43.10	± 4.780

With strip (Day 30 and 31)

Group	Value	95% CI
All Participants	43.89	± 4.628

Peak Sore Sound Intensity : Baseline, Active and Nasal Resistance Phase Secondary · Day 1, Day 8, Day 29, Day 30 and Day 31

The Investigator or designee recorded the peak snore sound intensity during the participant's domiciled sleep visits. Peak snore sound intensity was recorded for all participants with strip on Day 1 (Visit 2) in baseline phase, Day 8 (Visit 3) and Day 29 (Visit 4) in active phase, and in participants with and without strip on Day 30 (Visit 5) and Day 31 (Visit 6) cumulatively, in nasal resistance phase.

Day 1

Group	Value	95% CI
All Participants	67.84	± 9.944

Day 8

Group	Value	95% CI
All Participants	66.44	± 8.854

Day 29

Group	Value	95% CI
All Participants	69.87	± 8.876

Without strip (Day 30 and 31)

Group	Value	95% CI
All Participants	69.48	± 13.525

With strip (Day 30 and 31)

Group	Value	95% CI
All Participants	70.28	± 11.917

Percentage of Participants With Nasal Breathing Route : Baseline, Active and Nasal Resistance Phase Secondary · Day 1, Day 8, Day 29, Day 30 and Day 31

The Investigator or designee recorded the Nasal breathing route during the participant's domiciled sleep visits. Nasal breathing route was observed for all participants with strip on Day 1 (Visit 2) in baseline phase, Day 8 (Visit 3) and Day 29 (Visit 4) in active phase, and in participants with and without strip on Day 30 (Visit 5) and Day 31 (Visit 6) cumulatively, in nasal resistance phase.

Day 1

Group	Value	95% CI
All Participants	26.38	± 27.322

Day 8

Group	Value	95% CI
All Participants	27.78	± 28.200

Day 29

Group	Value	95% CI
All Participants	31.25	± 29.558

Without strip (Day 30 and 31)

Group	Value	95% CI
All Participants	44.71	± 31.139

With strip (Day 30 and 31)

Group	Value	95% CI
All Participants	48.40	± 28.899

Adverse events — posted to ClinicalTrials.gov

Time frame: Upto 31 days. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

All Participants (Baseline Phase)

Serious: 0/91 (0%)

Deaths: 0/91

All Participants (Active Phase)

Serious: 1/70 (1%)

Deaths: 0/70

Participants With Strip (Nasal Resisatnce Phase)

Serious: 0/55 (0%)

Deaths: 0/55

Participants Without Strip (Nasal Resisatnce Phase)

Serious: 0/55 (0%)

Deaths: 0/55

Serious adverse events (1 terms)

Reaction	System	All Participants (Baseline…	All Participants (Active P…	Participants With Strip (N…	Participants Without Strip…
Bell's Palsy	Infections and infestations	—	—	—	—

Other adverse events (27 terms — click to expand)

Reaction	System	All Participants (Baseline…	All Participants (Active P…	Participants With Strip (N…	Participants Without Strip…
NASOPHARYNGITIS	Infections and infestations	—	—	—	—
OROPHARYNGEAL PAIN	Respiratory, thoracic and mediastinal disorders	—	—	—	—
HEADACHE	Nervous system disorders	—	—	—	—
INFLUENZA	Infections and infestations	—	—	—	—
Tonsillitis	Infections and infestations	—	—	—	—
RHINORRHOEA	Respiratory, thoracic and mediastinal disorders	—	—	—	—
Epistaxis	Respiratory, thoracic and mediastinal disorders	—	—	—	—
GASTROENTERITIS VIRAL	Infections and infestations	—	—	—	—
SUNBURN	Injury, poisoning and procedural complications	—	—	—	—
COUGH	Respiratory, thoracic and mediastinal disorders	—	—	—	—
BRONCHITIS	Infections and infestations	—	—	—	—
FLATULENCE	Gastrointestinal disorders	—	—	—	—
CLAUSTROPHOBIA	Psychiatric disorders	—	—	—	—
NASAL CONGESTION	Respiratory, thoracic and mediastinal disorders	—	—	—	—
SEASONAL ALLERGY	Immune system disorders	—	—	—	—
RHINALGIA	Respiratory, thoracic and mediastinal disorders	—	—	—	—
SKIN IRRITATION	Skin and subcutaneous tissue disorders	—	—	—	—
APPLICATION SITE REACTION	General disorders	—	—	—	—
NASAL DISCOMFORT	Respiratory, thoracic and mediastinal disorders	—	—	—	—
VIIth NERVE PARALYSIS	Nervous system disorders	—	—	—	—
APPLICATION SITE FISSURE	General disorders	—	—	—	—
Application site haematoma	General disorders	—	—	—	—
BLOOD CHOLESTEROL Increased	Investigations	—	—	—	—
EXCORIATION	Injury, poisoning and procedural complications	—	—	—	—
BASAL CELL CARCINOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—	—
SOMNOLENCE	Nervous system disorders	—	—	—	—
TINEA PEDIS	Infections and infestations	—	—	—	—

Most-reported serious reactions: Bell's Palsy.

Data from ClinicalTrials.gov NCT03105297 adverse events section.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Objective and Subjective Effects of a Prototype Nasal Dilator Strip on Sleep in Subjects with Chronic Nocturnal Nasal Congestion.
   Wheatley JR, Amis TC, Lee SA, Ciesla R, et al · · 2019 · cited 1× · PMID 31119695 · DOI 10.1007/s12325-019-00980-z