Non-interventional Study of Ectoin Nasal Douche (END01) in Patients With Acute Viral Rhinosinusitis

NCT03480100 | Completed

• 1 other identifier: PPL-106
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this non interventional study is to investigate the efficacy, tolerability and safety of the newly developed Ectoin Nasal Douche END01. Within the study, END01 will be used as concomitant therapy in addition to the use of a Xylometazoline-containing decongestant nasal spray. It will be investigated if the dosis of the used decongestant nasal spray might be reduced, the development of the disease might be positively influenced and/or the potentially occuring side effects (e.g. dryness of the nasal mucosa, sneezing) might be alleviated by using the Ectoin Nasal Douche as concomitant therapy.

Conditions

Acute Rhinosinusitis

Keywords

rhinosinusitis; nasal irrigation; nasal douche; Ectoin

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Physicians' assessment of general well-being of patients

  day 0 and day 7 and day 14 (if necessary, depending on study duration)

• Patients' assessment of intensity of symptoms and their influence on quality of life

  7 to 14 days (depending on study duration)

• Assessment of the efficacy of treatments

  day 7 or day 14 (depending on study duration)

• Assessment of the tolerability of treatments

  day 7 or day 14 (depending on study duration)

• Incidence of adverse events/serious adverse events

  7 to 14 days (depending on study duration)

Study Arms (2)

Xylometazoline Nasal spray

1 spray per nostril as often as required but not exceeding 3 sprays per nostril per day

Drug: Xylometazoline Nasal Spray

Xylometazoline + Ectoin Nasal Douche

Xylometazoline: 1 spray per nostril as often as required but not exceeding 3 sprays per nostril per day, Ectoin Nasal Douche (END01): 1 spray per nostril 2-6 times per day or as often as required

Drug: Xylometazoline Nasal Spray; Device: Ectoin Nasal Douche

Interventions

Xylometazoline Nasal Spray DRUG

Application of Xylometazoline Nasal Spray in accordance with the instructions for use

Also known as: NasenSpray-ratiopharm Erwachsene (adults)

Xylometazoline + Ectoin Nasal Douche; Xylometazoline Nasal spray

Ectoin Nasal Douche DEVICE

Application of Ectoin Nasal Douche (END01) in accordance with the instructions for use

Also known as: END01

Xylometazoline + Ectoin Nasal Douche

Eligibility Criteria

• Age: 6 Years+
• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients aged above 6 years diagnosed with acute viral rhinosinusitis

You may qualify if:

• patients with acute viral rhinosinusitis
• presence of common cold symptoms

You may not qualify if:

• contraindications in accordance with instructions for use
• acute bacterial rhinosinusitis
• chronic rhinosinusitis

Sponsors & Collaborators

• Bitop AG: lead

Study Sites (1)

bitop AG

Witten, North Rhine-Westphalia, 58453, Germany

Location

MeSH Terms

Conditions

Rhinosinusitis

Condition Hierarchy (Ancestors)

Rhinitis; Respiratory Tract Infections; Infections; Sinusitis; Paranasal Sinus Diseases; Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases

Study Officials

• Andreas Bilstein, Dr.

  CSO

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: November 30, 2017
• First Posted: March 29, 2018
• Study Start: November 27, 2017
• Primary Completion: May 31, 2018
• Study Completion: May 31, 2018
• Last Updated: July 11, 2018

Record last verified: 2018-07

Locations

DE (1)