Non Interventional Study (NIS) Regarding the Application of Ectoin Mund- & Rachenspray in Patients With Acute Laryngitis and/or Acute Pharyngitis

NCT02160912 | Completed DMC

• 1 other identifier: EctMRS/aLR/2014
• Study Type: observational
• Target: 95
• Locations: 1 country
• Sites: 8

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.

Conditions

Acute Pharyngitis; Acute Laryngitis

Outcome Measures

Primary Outcomes (1)

• Change in Pharyngitis symptom score evaluated by the physician

  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

  Visit 1, Visit 2 (after 3 days), Visite 3 (after 7 days)

Secondary Outcomes (8)

• Change in patient's general condition evaluated by the physician

  Visit 1, Visit 2 (after 3 days), Visit 3 (after 7 days)

• Change in Evaluation of the hoarseness

  Visit 1, Visit 2 (after 3 days), Visit 3 (after 7 days)

• Change in Dysphagia

  Visit 1, Visit 2 (after 3 days), Visit 3 (after 7 days)

• Change in efficacy evaluation by the physician

  Visit 1, Visit 2 (after 3 days), Visit 3 (after 1 week)

• Change in efficacy evaluation by the patient

  Visit 1, Visit 2 (after 3 days), Visit 3 (after 7 days)

Study Arms (2)

Ectoin Mund- & Rachenspray

treatment with Ectoin Mund- \& Rachenspray 1%

Emser Pastillen

treatment with Emser Pastillen

Eligibility Criteria

• Age: 6 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• Patients with acute Laryngitis and/or Pharyngitis which are already treated with Ectoin Mund- \& Rachenspray 1% or Emser Pastillen

You may not qualify if:

• contraindications according to instructions for use

Sponsors & Collaborators

• Bitop AG: lead

Study Sites (8)

Norbert Pasch-Facharzt für HNO Heilkunde

Aachen, 52074, Germany

Location

HNO Praxis Aachen Brand

Aachen, 52078, Germany

Location

Taufik Shahab -Facharzt für HNO Heilkunde

Cologne, 50667, Germany

Location

Bey - Facharzt f. HNO Heilkunde

Cologne, 50933, Germany

Location

HNO-Praxis Peter Hinterkausen & Dr. med. Eva Bottler-Neufert

Cologne, 50935, Germany

Location

HNo Praxis Dr. Uta Thieme

Duisburg, 47051, Germany

Location

Dr. Lenzenhuber-Fachärztin für HNO Heilkunde

Jülich, 52428, Germany

Location

Wilhelm Schütz -Facharzt für HNO Heilkunde

Jülich, 52428, Germany

Location

MeSH Terms

Conditions

Croup

Condition Hierarchy (Ancestors)

Laryngitis; Laryngeal Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases

Study Officials

• Ralph Mösges, MD

  Klinikum der Universität zu Köln

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2014
• First Posted: June 11, 2014
• Study Start: February 1, 2014
• Primary Completion: July 1, 2014
• Study Completion: December 1, 2014
• Last Updated: January 9, 2015

Record last verified: 2015-01

Locations

DE (8)