Comparison Between 4 Different Nasal Dilators

Incompetence of Nasal Valve Clinical Trial

Official title:

Comparison Between 4 Different Nasal Dilators: Objective vs Subjective Parameters

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02196389
• Other study ID #: Dec2013
• Status: Recruiting
• Phase: Phase 4
• First received: July 17, 2014
• Last updated: December 2, 2015
• Start date: September 2014
• Est. completion date: March 2016

Study information

• Verified date: December 2015
• Source: Universitaire Ziekenhuizen Leuven
• Contact: Peter Hellings, Prof Dr
• Phone: +321632338
• Email: peter.hellings[@]uzleuven.be
• Is FDA regulated: No
• Health authority: Belgium: Ethics Committee
• Study type: Interventional

Clinical Trial 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

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,

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Incompetence of Nasal Valve

Intervention

Device:
• Nasal dilator Nasanita
Nasal Dilator
• Nasal dilator Nozovent

• Nasal dilator Breath Right

• Nasal dilator Airmax

Locations

Country	Name	City	State
Belgium	UZ Leuven	Leuven	Vlaams-Brabant

Sponsors (1)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	No
Other	reasons of choice	Specific reasons for the choice of the two dilators at baseline (functional vs aesthetic) at baseline	4 weeks	No
Primary	Peak Nasal Inflammatory Flow	Change in Peak Nasal Inflammatory Flow between the 4 different dilators	4 weeks	No
Secondary	preference	Patients' preference of 2 out of 4 dilators tested at baseline for a trial period of 4 week duration.	4 weeks	No