Comparison Between 4 Different Nasal Dilators

Study Overview
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Brief Summary
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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
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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,

Official Title
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Comparison Between 4 Different Nasal Dilators: Objective vs Subjective Parameters

Conditions
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Incompetence of Nasal Valve

Intervention / Treatment
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* Device: Nasal dilator Nasanita
* Device: Nasal dilator Nozovent
* Device: Nasal dilator Breath Right
* Device: Nasal dilator Airmax


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Nozovent<br>Nasal Dilator | Device: Nasal dilator Nozovent<br> <br> |
| Active Comparator: Nasanita<br>Nasal Dilator | Device: Nasal dilator Nasanita<br>* Nasal Dilator<br>* Other names: Nasanita;|
| Active Comparator: Breath Right<br>Nasal Dilator | Device: Nasal dilator Breath Right<br> <br> |
| Active Comparator: Airmax<br>Nasal Dilator | Device: Nasal dilator Airmax<br> <br> |

What is the study measuring?
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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 |