Condition category
Ear, Nose and Throat
Date applied
17/06/2017
Date assigned
30/06/2017
Last edited
30/06/2017
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Chronic rhinosinusitis (CRS) is a disease that causes inflammation (swelling) in the sinus (inside the nose). This can block the airways and cause severe pain. Patients suffering from CRS report interruptions in their daily activities, well-being and quality of life. The main treatment for CRS is to use a topical nasal treatment that contain steroids (anti-inflammatory medications), usually as a spray. Using those treatments, as well as saline irrigation (a salt water rinse to wash out anything in the nose) has shown to improve the symptoms of CRS and improve quality of life in patients who have not been treated. Saline irrigation has been recommended to be used after surgery to promote healing. However, if this should be done as a nasal douche (sniffing the saline solution into one nostril and letting it run out) or nasal spray has not been determined. The steroid treatments have shown to be effective at reducing inflammation. Still, patients are not fully cured under this treatment. Carrageenan (a common food additive used as a thickener) nasal spray has been investigated in patients who have a common cold. It can increase the viscosity (thickness) if applied as a nasal spray, prolonging the moisture of the nasal mucosa. This requires more research to see how it works. This study evaluates the impact of a medical device, a carrageenan nasal spray, on quality of life in patients diagnosed with CRS.

Who can participate?
Adults aged 18 and older who are diagnosed with CRS.

What does the study involve?
Participants are allocated to groups. Those in the first group have not received treatment. The second group consists of participants who underwent functional endoscopic sinus surgery. In these two groups, participants are randomised to either receiving the treatment or the placebo (dummy treatment). All participants are given the study device and are asked to use if five times a day every two to three hours for 60 days. Participants fill out questionnaires prior to treatment, at 60 days and 90 days to assess their quality of life.

What are the possible benefits and risks of participating?
There are no notable benefits or risks with participating.

Where is the study run from?
Medical University of Vienna (Austria)

When is the study starting and how long is it expected to run for?
October 2016 to December 2019

Who is funding the study?
Medical University of Vienna (Austria)

Who is the main contact?
Dr Sven Schneider
sven.schneider@meduniwien.ac.at

Trial website

Contact information

Type

Scientific

Primary contact

Dr Sven Schneider

ORCID ID

http://orcid.org/0000-0002-7631-3746

Contact details

Medical Universtiy of Vienna
Waehringer Gürtel 18-10
Vienna
1090
Austria

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

CRS-17

Study information

Scientific title

Effects of carrageenan nasal spray as additive therapy on quality of life and clinical outcome in patients diagnosed with chronic rhinosinusitis

Acronym

Study hypothesis

Carrageenan nasal spray significantly improves quality of life in Patients diagnosed with chronic rhinosinusitis.

Ethics approval

Ethics Committee Medical University of Vienna, 19/05/2017, ref: 2254/2016

Study design

Prospective single-centre double-blind randomised controlled interventional trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Quality of life

Patient information sheet

See additional files (in German)

Condition

Chronic Rhinosinusitis

Intervention

Patients diagnosed with chronic rhinosinusitis who did not receive any treatment in the past three months or patients diagnosed with chronic rhinosinusitis presenting for functional endoscopic sinus surgery are eligible to participate in this study. Participants are sorted to one of two groups. Those in the first group are the treatment naïve group. Those in the second group are participants who recently underwent functional endoscopic sinus surgery. In these two groups, patients are subsequently randomised to either receiving the intervention treatment or the control treatment. All participant receives a study device, however those in the control group have a placebo treatment. The study device is used five times a day at intervals of two to three hours for 60 days in each group. Randomisation of the study device are performed stratified, separately for the group of treatment naive patients and the group of patients presenting for surgery.

Participants in the treatment naive group receive treatment with topical steroids and saline irrigation according to the hospitals’ standards. Additionally, patients receive the randomised study device. Therapy consisting of topical steroids, saline irrigation and study device will be applied for 60 days. Follow up time is 90 days and quality of life questionnaire SNOT-20 GAV are completed at time of enrollment, 60 days after enrollment and 90 days after enrollment.

Participants in the group presenting for surgery receive post operative treatment with topical steroids and saline irrigation according to the hospitals’ standards. Additionally, participants receive the randomized study device. Therapy consisting of topical steroids, saline irrigation and study device will be applied for 60 days. Follow up time is 90 days and quality of life questionnaire SNOT-20 GAV will be asked at time of enrollment, 60 days after enrollment and 90 days after enrollment.

Intervention type

Device

Phase

Drug names

Primary outcome measures

Quality of life is measured using SNOT-20 GAV questionnaire at baseline, after 60 days of treatment and 30 days after completion of treatment.

Secondary outcome measures

1. Necessity of surgery in the treatment naive group will be evaluated 90 days after enrollment
2. Onset of improved quality of life will be evaluated after 60 days of treatment

Overall trial start date

01/10/2016

Overall trial end date

01/12/2019

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients diagnosed with Chronic Rhinosinusitis who did not yet receive treatment and patients treated by functional endoscopic sinus surgery for the first time and have signed an informed consent form will be included in this study. If no medical treatment was applied in the last three months, patients are classified as treatment naive.
2. Chronic rhinosinusitis is diagnosed according to the clinical practice guidelines of the American Academy of Otolaryngology, Head and Neck Surgery. Patients meet the criteria when the following conditions are found:
2.1. Twelve weeks or longer of two or more of the following signs and symptoms:
2.1.1. Mucopurulent drainage (anterior, posterior, or both)
2.1.2. Nasal obstruction (congestion)
2.1.3. Facial pain-pressure-fullness or decreased sense of smell
2.2. Inflammation is documented by one or more of the following findings:
2.2.1. Purulent (not clear) mucus or edema in the middle meatus or anterior ethmoid region,
2.2.2. Polyps in nasal cavity or the middle meatus, and/or
2.2.3. Radiographic imaging showing inflammation of the paranasal sinuses
3. Ability to sign informed consent form
4. Signed informed consent form
5. Age over 18 years
6. Computed tomography scan showing signs of inflammation in the paranasal sinuses

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

220

Participant exclusion criteria

1. Patients diagnoses with medical conditions like allergic rhinitis, cystic fibrosis, immunocompromised state, ciliary dyskinesia, acetylsalicylic acid intolerance or severe anatomic variations
2. Pregnant women and minors
3. Patients who received nasal corticosteroid therapy for Chronic Rhinosinusitis in the prior three months and not presenting for surgery will not be included
4. Patients intending to use other nasal sprays during the study period, patients not able to use a nasal spray every day
5. Patients who had an adverse reaction to seaweed products will not be included

Recruitment start date

01/09/2017

Recruitment end date

01/06/2019

Locations

Countries of recruitment

Austria

Trial participating centre

Medical Universtiy of Vienna
Department of Otorhinolaryngology - Head and Neck Surgery Waehringer Gürtel 18-20
Vienna
1090
Austria

Sponsor information

Organisation

Medical University of Vienna

Sponsor details

Spitalgasse 23
Vienna
1090
Austria

Sponsor type

University/education

Website

Funders

Funder type

University/education

Funder name

Medical University of Vienna

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer reviewed journal in December 2020.

IPD sharing statement:
The datasets generated and analysed during the current study will be available upon request from sven.schneider@meduniwien.ac.at

Intention to publish date

31/12/2020

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes