## Protocol Section
### Identification Module
**NCT ID:** NCT02108379

**Brief Title:** Compliance and Usability Study Evaluating RHINIX™ Nasal Filters

**Official Title:** An Open-label Outpatient In-season Study Assessing Compliance and Usability of Rhinix™ Nasal Filters

#### Organization Study ID Info
**ID:** 00002
#### Organization
**Class:** OTHER
**Full Name:** University of Aarhus
### Status Module
#### Completion Date
**Date:** 2014-07

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2014-11-11

**Type:** ESTIMATED

**Last Update Submit Date:** 2014-11-10

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2014-07

**Type:** ACTUAL

#### Start Date
**Date:** 2014-05

**Status Verified Date:** 2014-03

#### Study First Post Date
**Date:** 2014-04-09
**Type:** ESTIMATED
**Study First Submit Date:** 2014-03-18
**Study First Submit QC Date:** 2014-04-04
### Sponsor Collaborators Module

#### Collaborators

**Class:** UNKNOWN

**Name:** Rhinix ApS

**Class:** UNKNOWN

**Name:** Astma-Allergi Danmark

#### Lead Sponsor

**Class:** OTHER

**Name:** University of Aarhus

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** This study will investigate usability and compliance related to rhinix nasal filters for the treatment of seasonal allergic rhinitis (hay fever) during the natural grass pollen season in Denmark.

### Conditions Module

**Conditions:**

- Seasonal Allergic Rhinitis

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 1073

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** All included will receive rhinix nasal filters

**Intervention Names:**

- Device: Rhinix Nasal Filters

**Label:** Rhinix Nasal Filters

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Rhinix Nasal Filters

**Name:** Rhinix Nasal Filters

**Type:** DEVICE

### Outcomes Module

#### Other Outcomes

**Description:** In week 1: To assess the correlation between symptom severity at screening and likelihood of answering that they will definitely/likely continue using the product.

**Measure:** Week 1: Correlation of use and allergy severiy

**Time Frame:** One assessment at the end of the 1st week of use

**Description:** Week 2: To assess the correlation between symptom severity at screening and likelihood of answering that they will definitely/likely continue using the product.

**Measure:** Week 2: Correlation between use and allergy severity

**Time Frame:** One assessment at the end of the 2nd week of use

**Description:** In week 1: To assess whether use of RHINIX has led to a perceived decrease in use of medication.

**Measure:** Week 1: Perceived decrease in medication

**Time Frame:** One assessment after the 1st week of use

**Description:** Week 2: To assess whether use of RHINIX has led to a perceived decrease in use of medication.

**Measure:** Week 2: Perceived decrease in medication

**Time Frame:** One assessment after 2nd week of use

#### Primary Outcomes

**Description:** In week 1: The proportion of subjects that rate that they will definitely or are likely to continue using RHINIX after the study is over given that they have stated that they have tried the device.

**Measure:** Week 1 likelihood of continued use of RHINIX after study end.

**Time Frame:** 1 assessment at the end of the 1st week of use.

**Description:** In week 2: The proportion of subjects that rate that they will definitely or are likely to continue using RHINIX after the study is over given that they have stated that they have tried the device.

**Measure:** Week 2 likelihood of continued use of RHINIX after study end.

**Time Frame:** 1 assessment at the end of the 2nd week of use.

#### Secondary Outcomes

**Description:** In week 1: The proportion of subjects who are completely or somewhat satisfied with RHINIX given that they have used the product.

**Measure:** Week 1 Satisfaction with RHINIX

**Time Frame:** 1 assessment at the end of the 1st week

**Description:** In week 2: The proportion of subjects who are completely or somewhat satisfied with RHINIX given that they have used the product.

**Measure:** Week 2 satisfaction with RHINIX

**Time Frame:** One assessment at the end of the 2nd week

**Description:** In week 1: The proportion of subjects who state that RHINIX has helped "to a very high degree" or "to a high degree" in controlling their hay fever symptoms given that they have used the product

**Measure:** Week 1: RHINIX Control

**Time Frame:** One assessment at the end of the 1st week of use

**Description:** In week 2: The proportion of subjects who state that RHINIX has helped "to a very high degree" or "to a high degree" in controlling their hay fever symptoms given that they have used the product

**Measure:** Week 2: RHINIX Control

**Time Frame:** One assessment at the end of the 2nd week of use.

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Motivated to try a different treatment approach to seasonal allergic rhinitis (documented by answering the call-out by Astma-Allergi Danmark)
* Indicates having seasonal allergic rhinitis to grass via online questionnaire
* Informed consent (by email acceptance after having received information on the trial)
* Assess to internet and email

Exclusion Criteria:

* Improper fit of the Rhinix™ device

**Maximum Age:** 65 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Aarhus

**Country:** Denmark

**Facility:** Aarhus University, School of Public Health, Department of Environmental & Occupational Medicine

**Zip:** 8000

#### Overall Officials

**Official 1:**

**Affiliation:** Aarhus University, School of Public Health, Dept. of Environmental & Occupational Medicine

**Name:** Torben Sigsgaard, Prof MD

**Role:** PRINCIPAL_INVESTIGATOR

### References Module

#### References

**Citation:** Kenney P, Hilberg O, Sigsgaard T. Clinical Application of Nasal Filters: An Observational Study on the Usability of Nasal Filters in Managing Seasonal Allergic Rhinitis. J Allergy Clin Immunol Pract. 2016 May-Jun;4(3):445-452.e4. doi: 10.1016/j.jaip.2016.01.003. Epub 2016 Feb 18.

**PMID:** 26897304

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000012141

- Term: Respiratory Tract Infections

- ID: D000007239

- Term: Infections

- ID: D000009668

- Term: Nose Diseases

- ID: D000012140

- Term: Respiratory Tract Diseases

- ID: D000010038

- Term: Otorhinolaryngologic Diseases

- ID: D000012130

- Term: Respiratory Hypersensitivity

- ID: D000006969

- Term: Hypersensitivity, Immediate

- ID: D000006967

- Term: Hypersensitivity

- ID: D000007154

- Term: Immune System Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC01

- Name: Infections

- Abbrev: BC08

- Name: Respiratory Tract (Lung and Bronchial) Diseases

- Abbrev: BC09

- Name: Ear, Nose, and Throat Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC20

- Name: Immune System Diseases

- Abbrev: BC23

- Name: Symptoms and General Pathology

### Condition Browse Module - Browse Leaves

- ID: M15049

- Name: Rhinitis

- Relevance: HIGH

- As Found: Rhinitis

- ID: M30545

- Name: Rhinitis, Allergic

- Relevance: HIGH

- As Found: Allergic Rhinitis

- ID: M9345

- Name: Rhinitis, Allergic, Seasonal

- Relevance: HIGH

- As Found: Seasonal Allergic Rhinitis

- ID: M10283

- Name: Infections

- Relevance: LOW

- As Found: Unknown

- ID: M6368

- Name: Communicable Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14978

- Name: Respiratory Tract Infections

- Relevance: LOW

- As Found: Unknown

- ID: M12604

- Name: Nose Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14977

- Name: Respiratory Tract Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12961

- Name: Otorhinolaryngologic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M10018

- Name: Hypersensitivity

- Relevance: LOW

- As Found: Unknown

- ID: M14967

- Name: Respiratory Hypersensitivity

- Relevance: LOW

- As Found: Unknown

- ID: M10020

- Name: Hypersensitivity, Immediate

- Relevance: LOW

- As Found: Unknown

- ID: M10200

- Name: Immune System Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000012220

- Term: Rhinitis

- ID: D000065631

- Term: Rhinitis, Allergic

- ID: D000006255

- Term: Rhinitis, Allergic, Seasonal

### Misc Info Module

- Version Holder: 2024-05-24
