Acute Laryngitis, Acute Pharyngitis
Conditions
Brief summary
In this observational study insights regarding the tolerability and influence on the quality of life of the topical treatment Ectoin Mund- and Rachenspray compared to Emser Pastillen in patients with acute Pharyngitis/ Laryngitis under real life conditions shall be gained. Patients are treated with Ectoin Mund- & Rachenspray 1% or Emser Pastillen according to the demands of the physician and the instructions for use.
Interventions
None listed
Sponsors
Bitop AG
Study design
Observational model
CASE_CROSSOVER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
6 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with acute Laryngitis and/or Pharyngitis which are already treated with Ectoin Mund- & Rachenspray 1% or Emser Pastillen
Exclusion criteria
* contraindications according to instructions for use
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pharyngitis symptom score evaluated by the physician | Visit 1, Visit 2 (after 3 days), Visite 3 (after 7 days) | Assessment of the symptoms of pharyngitis on a 4 point scale (none, mild, moderate strong): * swollen palatine tonsils * swollen lymph nodes in the throat * fever * cough |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Evaluation of the hoarseness | Visit 1, Visit 2 (after 3 days), Visit 3 (after 7 days) | physician's assessment of the hoarseness of the patient on a 4 point scale (none, mild, moderate, strong) |
| Change in Dysphagia | Visit 1, Visit 2 (after 3 days), Visit 3 (after 7 days) | physician's assessment of dysphagia of the patient on a 4 point scale (none, mild, moderate, strong) |
| Change in efficacy evaluation by the physician | Visit 1, Visit 2 (after 3 days), Visit 3 (after 1 week) | Assessment of the efficacy on a 4 point scale (0= bad, 1=sufficient, 2=good, 3=very good) |
| Change in patient's general condition evaluated by the physician | Visit 1, Visit 2 (after 3 days), Visit 3 (after 7 days) | Physician's assessment of the general conditions on a 4 point scale (good condition, slightly reduced condition, bad condition, very bad condition) |
| Change in Evaluation of the tolerability by the physician | Visit 1, Visit 2 (after 3 days), Visit 3 (after 7 days)) | Assessment of the tolerability by the physician on a 4 point scale (0= bad, 1=sufficient, 2=good, 3=very good) |
| Change in Evaluation of the tolerability by the patient | Visit 1, Visit 2 (after 3 days), Visit 3 (after 7 days)) | Assessment of the tolerability by the patient on a 4 point scale (0= bad, 1=sufficient, 2=good, 3=very good) |
| Change in number and type of adverse events | Visit 2 (after 3 days) Visit 3 (after 7 days) | incidence of adverse events and correlation with the therapy |
| Change in efficacy evaluation by the patient | Visit 1, Visit 2 (after 3 days), Visit 3 (after 7 days) | Assessment of the efficacy on a 4 point scale (0\_bad, 1=sufficient, 2=good, 3=very good) |
Countries
Germany
Outcome results
None listed