Comparison Between 4 Different Nasal Dilators

Phase 4

Terminated

• Conditions: Incompetence of Nasal Valve
• Interventions: Device: Nasal dilator Airmax; Device: Nasal dilator Nasanita; Device: Nasal dilator Breath Right; Device: Nasal dilator Nozovent

• Registration Number: NCT02196389
• Lead Sponsor: Universitaire Ziekenhuizen KU Leuven

Brief Summary

Several nasal dilators are currently commercially available, and can be applied endonasally (Airmax°, Nozovent and Nasanita°) or externally (Breath Right°). An objective comparison between these dilators has not been made so far, and would help the clinicians to advise the use of any of these dilators. From clinical experience, endonasal dilators are well supported and improve breathing better than the external dilators

Detailed Description

Several nasal dilators are currently commercially available, and can be applied endonasally (Airmax°, Nozovent and Nasanita°) or externally (Breath Right°). An objective comparison between these dilators has not been made so far,

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2014-07-17
• Study First Submitted QC: 2014-07-21
• Study First Posted: 2014-07-22
• Primary Completion: 2018-08-18
• Study Completion: 2018-08-18
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-09
• Last Update Posted: 2024-07-10

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Patients with nasal obstruction due to external nasal valve problems and with positive Cottle sign.

Age > 18 and < 60 years. Ability to give reliable information and written informed consent.

Exclusion Criteria

Patients with nasal obstruction due to other endonasal anatomic deformities besides external nasal valve dysfunction.

Patients with rhinosinusitis and/or nasal polyps evaluated by nasal endoscopy. Patients with chronic lower airway disease like severe asthma, chronic obstructive pulmonary disease (COPD), bronchiectasis and/or other conditions that interfere with the generation of a reliable Peak Nasal Inspiratory Flow (PNIF) result.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Airmax	Nasal dilator Airmax	Nasal Dilator
Nasanita	Nasal dilator Nasanita	Nasal Dilator
Breath Right	Nasal dilator Breath Right	Nasal Dilator
Nozovent	Nasal dilator Nozovent	Nasal Dilator

Primary Outcome Measures

Name	Time	Method
Peak Nasal Inflammatory Flow	4 weeks	Change in Peak Nasal Inflammatory Flow between the 4 different dilators

Secondary Outcome Measures

Name	Time	Method
preference	4 weeks	Patients' preference of 2 out of 4 dilators tested at baseline for a trial period of 4 week duration.

Trial Locations

Locations (1)

UZ Leuven; 🇧🇪 Leuven, Vlaams-Brabant, Belgium