Comparison Between 4 Different Nasal Dilators | NCT02196389

Studies
Comparison Between 4 Different Nasal Dilators

NCT02196389

Sponsor

Universitaire Ziekenhuizen KU Leuven

Status

Terminated

Last Update Posted

Jul 10, 2024Actual

Enrollment

100Actual

Phase

Phase 4

Conditions

Incompetence of Nasal Valve

Interventions

Nasal dilator Nasanita
Nasal dilator Nozovent
Nasal dilator Breath Right
Nasal dilator Airmax

Countries

Belgium

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2024

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

No contract, no costs

Expanded Access Info

Start Date

Jan 2014Actual

Primary Completion Date

Aug 18, 2018Actual

Completion Date

Aug 18, 2018Actual

First Submitted Date

Jul 17, 2014

First Submission Date that Met QC Criteria

Jul 21, 2014

First Posted Date

Jul 22, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 9, 2024

Last Update Posted Date

Jul 10, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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
Airmax	Active Comparator	Nasal Dilator	Device: Nasal dilator Airmax

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Nasal dilator Nasanita	Device	Nasal Dilator	Nasanita	Nasanita

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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 Outcomes

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

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Peter Hellings, Prof Dr	UZ Leuven	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
UZ Leuven		Leuven	Vlaams-Brabant	3000	Belgium