Does carrageenan nasal spray improve quality of life in patients with chronic rhinosinusitis?

Recruiting

• Conditions: Chronic Rhinosinusitis; Ear, Nose and Throat

• Registration Number: ISRCTN15435307
• Lead Sponsor: Medical University of Vienna

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-06-30
• Last Update Posted: 24 July 2017

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 220

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified