Acute Rhinosinusitis Clinical Trial
Official title:
Non-interventional Study in Patients With Acute Rhinosinusitis to Study Efficacy and Tolerability of Ectoin Rhinosinusitis Nasal Spray, a Xylometazoline-containing Nasal Spray or a Combination of Both.
Verified date | November 2018 |
Source | Bitop AG |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The goal of this non-interventional study is to investigate the efficacy and tolerability of
an Ectoin containing Rhinosinusitis Nasal Spray (SNS01). Within the study, SNS01 will be used
either alone as monotherapy or as concomitant therapy in addition to the use of a
Xylometazoline-containing decongestant nasal spray. A control group will use a
Xylometazoline-containing decongestant nasal spray as monotherapy.
It will be investigated if the dose of the used decongestant nasal spray might be reduced,
the development of the disease might be positively influenced and/or the potentially
occurring side effects (e.g. dryness of the nasal mucosa, sneezing) might be alleviated by
using the Ectoin containing Rhinosinusitis Nasal Spray as concomitant therapy.
Status | Completed |
Enrollment | 168 |
Est. completion date | April 15, 2019 |
Est. primary completion date | April 15, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 6 Years and older |
Eligibility |
Inclusion Criteria: - patients with acute viral rhinosinusitis - presence of common cold symptoms Exclusion Criteria: - contraindications in accordance with instructions for use - acute bacterial rhinosinusitis - chronic rhinosinusitis |
Country | Name | City | State |
---|---|---|---|
Germany | bitop AG | Dortmund |
Lead Sponsor | Collaborator |
---|---|
Bitop AG |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Physicians' assessment of change of intensity of rhinosinusitis symptoms | Both on day 0 and on day 7 (and, if necessary, depending on study duration, on day 14), the physicians will assess rhinosinusitis symptoms oedema, redness of the nose, nasal obstruction, nasal secretion, facial pain/headache, smell/taste dysfunction and the concomitant symptoms dryness of the nasal mucosa and sore throat. Assessment will be carried out based on a 5-point scale (0=none to 4=very strong). Change of symptoms will be assessed comparing symptom scores on day 7 (or day 14, if applicable) to day 0. The investigators will use rhinoscopy, physical examination and interview of the patients for the assessments. | day 0 and day 7 and (if necessary, depending on study duration) and on day 14 | |
Secondary | Physicians' assessment of general well-being of patients | The investigators will assess the well-being of patients using a 4-point scale (good condition to strong illness). | day 0 and day 7 and day 14 (if necessary, depending on study duration) | |
Secondary | Patients' assessment of intensity of symptoms and their influence on quality of life | Patients will document their rhinosinusitis symptoms and their influence on quality of life (22 parameters in accordance with the "sino-nasal outcome test-22 questionnaire") and the additional symptom "dry nose". They will document their judgement daily in a patient diary using a 6-point scale (0=no problem to 5=as bad as possible). | 7 to 14 days (depending on study duration) | |
Secondary | Investigators' and patients' assessment of efficacy of treatments | At the end of the study, both investigators and patients will judge the overall efficacy of the treatment based on a 6-point scale (1=very good to 6=unsatisfactory). | once on day 7 or day 14 (depending on study duration) | |
Secondary | Assessment of the tolerability of treatments | Both investigators and patients will judge the tolerability of the treatments at the end of the study. Both investigators and patients will judge the tolerability based on a 6 point scale (1=very good to 6 = unsatisfactory). | once on day 7 or once on day 14 of treatment (depending on study duration) | |
Secondary | Incidence of adverse events/serious adverse events | All occurring adverse events/serious adverse events will be documented during the entire study period. | 7 to 14 days (depending on study duration) |
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