Comparison Between 4 Different Nasal Dilators

Comparison Between 4 Different Nasal Dilators: Objective vs Subjective Parameters

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 Overview

• Status: Terminated
• Conditions: Incompetence of Nasal Valve
• Intervention / Treatment: Device: Nasal dilator Nozovent; Device: Nasal dilator Nasanita; Device: Nasal dilator Breath Right; Device: Nasal dilator Airmax

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 Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 4

Contacts and Locations

Study Locations

• Belgium
  • Vlaams-Brabant
    • Leuven, Vlaams-Brabant, Belgium, 3000
      • UZ Leuven

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Nozovent; Nasal Dilator	Device: Nasal dilator Nozovent
Active Comparator: Nasanita; Nasal Dilator	Device: Nasal dilator Nasanita; Nasal Dilator; Other Names: Nasanita
Active Comparator: Breath Right; Nasal Dilator	Device: Nasal dilator Breath Right
Active Comparator: Airmax; Nasal Dilator	Device: Nasal dilator Airmax

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peak Nasal Inflammatory Flow	Change in Peak Nasal Inflammatory Flow between the 4 different dilators	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
preference	Patients' preference of 2 out of 4 dilators tested at baseline for a trial period of 4 week duration.	4 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
surgery	Patients' preference to continue to use the preferred dilator after the 4 weeks' trial period or choice to undergo surgery after one month of usage of the preferred dilator.	4 weeks
reasons of choice	Specific reasons for the choice of the two dilators at baseline (functional vs aesthetic) at baseline	4 weeks

Collaborators and Investigators

• Sponsor: Universitaire Ziekenhuizen KU Leuven
• Investigators: Principal Investigator: Peter Hellings, Prof Dr, UZ Leuven

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2014
• Primary Completion (Actual): August 18, 2018
• Study Completion (Actual): August 18, 2018

Study Registration Dates

• First Submitted: July 17, 2014
• First Submitted That Met QC Criteria: July 21, 2014
• First Posted (Estimated): July 22, 2014

Study Record Updates

• Last Update Posted (Actual): July 10, 2024
• Last Update Submitted That Met QC Criteria: July 9, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: S56842