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Comparison Between 4 Different Nasal Dilators

U

Universitaire Ziekenhuizen KU Leuven

Status and phase

Terminated
Phase 4

Conditions

Incompetence of Nasal Valve

Treatments

Device: Nasal dilator Airmax
Device: Nasal dilator Nasanita
Device: Nasal dilator Breath Right
Device: Nasal dilator Nozovent

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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

Full 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,

Enrollment

100 patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Other

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

100 participants in 4 patient groups

Nozovent
Active Comparator group
Description:
Nasal Dilator
Treatment:
Device: Nasal dilator Nozovent
Nasanita
Active Comparator group
Description:
Nasal Dilator
Treatment:
Device: Nasal dilator Nasanita
Breath Right
Active Comparator group
Description:
Nasal Dilator
Treatment:
Device: Nasal dilator Breath Right
Airmax
Active Comparator group
Description:
Nasal Dilator
Treatment:
Device: Nasal dilator Airmax

Trial contacts and locations

1

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Central trial contact

Peter Hellings, Prof Dr

Data sourced from clinicaltrials.gov

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