Clinical trial NCT02160912: Non Interventional Study (NIS) Regarding the Application of Ectoin Mund- & Rachenspray in Patients With Acute Laryngitis and/or Acute Pharyngitis
Official title: Non Interventional Study Regarding the Application of Ectoin Mund- & Rachenspray in Patients With Acute Laryngitis and/or Acute Pharyngitis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Pharyngitis
Acute Laryngitis
Lead sponsor: Bitop AG
Sponsor class: INDUSTRY
First posted: 2014-06-11
Enrollment: 95
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primary care unit In this non interventional study the therapy process of a total of 90 patients with acute pharyngitis and/or laryngitis for which the physician has planned a therapy with Ectoin Mund- \& Rachenspray 1% (60 Patients) or Emser Pastillen (30 patients) shall be observed in 8 clinical centers

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in Pharyngitis symptom score evaluated by the physician
timeFrame: Visit 1, Visit 2 (after 3 days), Visite 3 (after 7 days)
Secondary outcomes:
measure: Change in patient's general condition evaluated by the physician
timeFrame: Visit 1, Visit 2 (after 3 days), Visit 3 (after 7 days)
measure: Change in Evaluation of the hoarseness
timeFrame: Visit 1, Visit 2 (after 3 days), Visit 3 (after 7 days)
measure: Change in Dysphagia
timeFrame: Visit 1, Visit 2 (after 3 days), Visit 3 (after 7 days)
measure: Change in efficacy evaluation by the physician
timeFrame: Visit 1, Visit 2 (after 3 days), Visit 3 (after 1 week)
measure: Change in efficacy evaluation by the patient
timeFrame: Visit 1, Visit 2 (after 3 days), Visit 3 (after 7 days)
measure: Change in Evaluation of the tolerability by the physician
timeFrame: Visit 1, Visit 2 (after 3 days), Visit 3 (after 7 days))
measure: Change in Evaluation of the tolerability by the patient
timeFrame: Visit 1, Visit 2 (after 3 days), Visit 3 (after 7 days))
measure: Change in number and type of adverse events
timeFrame: Visit 2 (after 3 days) Visit 3 (after 7 days)
Other outcomes:
Locations:
city: Aachen
country: Germany
facility: Norbert Pasch-Facharzt für HNO Heilkunde
city: Aachen
country: Germany
facility: HNO Praxis Aachen Brand
city: Duisburg
country: Germany
facility: HNo Praxis Dr. Uta Thieme
city: Jülich
country: Germany
facility: Dr. Lenzenhuber-Fachärztin für HNO Heilkunde
city: Jülich
country: Germany
facility: Wilhelm Schütz -Facharzt für HNO Heilkunde
city: Köln
country: Germany
facility: Taufik Shahab -Facharzt für HNO Heilkunde
city: Köln
country: Germany
facility: Bey - Facharzt f. HNO Heilkunde
city: Köln
country: Germany
facility: HNO-Praxis Peter Hinterkausen & Dr. med. Eva Bottler-Neufert
Study officials:
affiliation: Klinikum der Universität zu Köln
name: Ralph Mösges, MD
role: PRINCIPAL_INVESTIGATOR
References: