Trials Sponsors Conditions Drugs Pricing

Loading search results

Platform

Search Trials
Sponsors
Conditions
Drugs
Directory

Resources

API Docs
Search Guide
FAQ
Pricing

Company

Contact
Privacy Policy
Terms of Service

Clinical trials intelligence platform

Trials
Incompetence of Nasal Valve
NCT02196389

NCT02196389

TerminatedPhase 4

Comparison Between 4 Different Nasal Dilators

Universitaire Ziekenhuizen KU Leuven Source

Navigation

Reading progress0%

NCT02196389|TerminatedPhase 4

Study Stopped

No contract, no costs

Comparison Between 4 Different Nasal Dilators

Universitaire Ziekenhuizen KU Leuven

ClinicalTrials.gov

Compare

Other study identifiers

Sponsor study identifier

S56842

Study Type

interventional

Actual enrollment (reported)

100

Locations

1 country

Sites

Timeline

Study Start

January 2014

Actual (reported)

Primary Completion

August 18, 2018

Actual (reported)

Study Completion

August 18, 2018

Actual (reported)

Brief 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

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: terminated
Actual enrollment (reported): 100 participants
Study completion date: August 18, 2018
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Some registry-reported names shown below are not yet linked in this graph.

Related Scientific Literature

Loading related publications...

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
January 2014
Actual (reported)
First Submitted
July 17, 2014
Actual (reported)
First Posted
July 22, 2014
Actual (reported)
Primary Completion
August 18, 2018
Actual (reported)
Study Completion
August 18, 2018
Actual (reported)

Last Updated: July 10, 2024
Status Verified: July 2024
Last Update Submitted: July 9, 2024

Conditions

Incompetence of Nasal Valve

Outcome Measures

Primary Outcomes (1)

Peak Nasal Inflammatory Flow
Change in Peak Nasal Inflammatory Flow between the 4 different dilators
4 weeks

Secondary Outcomes (1)

preference
4 weeks

Other Outcomes (2)

surgery
4 weeks
reasons of choice
4 weeks

Study Arms (4)

Nozovent

ACTIVE COMPARATOR

Nasal Dilator

Device: Nasal dilator Nozovent

Nasanita

ACTIVE COMPARATOR

Nasal Dilator

Device: Nasal dilator Nasanita

Breath Right

ACTIVE COMPARATOR

Nasal Dilator

Device: Nasal dilator Breath Right

Interventions

Nasal dilator NasanitaDevice

Nasal Dilator

Also known as: Nasanita

Nasanita

Nasal dilator NozoventDevice

Nozovent

Eligibility Criteria

Age18 Years - 60 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64)

You may qualify if:

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.

You may not qualify if:

Sponsors & Collaborators

Universitaire Ziekenhuizen KU Leuven
Otherlead

Study Sites (1)

UZ Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

Study Officials

Peter Hellings, Prof Dr
UZ Leuven
PRINCIPAL INVESTIGATOR

Enrollment

100 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 4
Allocation: NON RANDOMIZED
Masking: NONE
Purpose: OTHER
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

July 17, 2014

First Posted

July 22, 2014

Study Start

January 2014

Actual (reported)

Primary Completion

Airmax

ACTIVE COMPARATOR

Nasal Dilator

Device: Nasal dilator Airmax

Nasal dilator Breath RightDevice

Breath Right

Nasal dilator AirmaxDevice

Airmax

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

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.

Contact the study team to confirm eligibility.

August 18, 2018

Actual (reported)

Study Completion

August 18, 2018

Actual (reported)

Last Updated

July 10, 2024

Record last verified: 2024-07

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT02196389
Data provider: ClinicalTrials.gov
Source updated: 2024-07-10
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:29:15 UTC

Locations

BE(1)