Comparison Between 4 Different Nasal Dilators

Phase 4TerminatedNCT02196389

Universitaire Ziekenhuizen KU Leuven100 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

100

Conditions

Incompetence of Nasal Valve

Interventions

Nasal dilator NasanitaDEVICE

Nasal Dilator

Nasal dilator NozoventDEVICE

Nasal dilator Breath RightDEVICE

Nasal dilator Airmax

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

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.

Locations (1)

UZ Leuven

Leuven, Vlaams-Brabant, Belgium

Outcomes

Primary Outcomes

Peak Nasal Inflammatory Flow

Change in Peak Nasal Inflammatory Flow between the 4 different dilators

Time frame: 4 weeks

Secondary Outcomes

preference

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

Time frame: 4 weeks

Data from ClinicalTrials.gov

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