Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | PHASE2 | COMPLETED | 91 | — | — | Sep 25, 2009 | Aug 10, 2010 | Jul 26, 2019 | 1 | Australia |
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.
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.
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.
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.
| Arm | Type | Description |
|---|---|---|
| All participants (Baseline phase) | EXPERIMENTAL | All the participants were applied nasal dilator strip during the sleep laboratory night on Day 1. |
| 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 |
| 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 |
| Name | Type | Description |
|---|---|---|
| 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. |
| No strip | OTHER | - |
Inclusion Criteria: * 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 Excl...