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NCT03480100
Non-interventional Study of Ectoin Nasal Douche (END01) in Patients With Acute Viral Rhinosinusitis
trial testing Xylometazoline Nasal Spray in Acute Rhinosinusitis in 120 participants. Completed in 31 May 2018.
31 May 2018
Quick facts
| Lead sponsor | Bitop AG |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 120 |
| Start date | 27 November 2017 |
| Primary completion | 31 May 2018 |
| Estimated completion | 31 May 2018 |
| Sites | 1 location across Germany |
Drugs / interventions tested
- Xylometazoline Nasal Spray
- Ectoin Nasal Douche
Conditions studied
- Acute Rhinosinusitis — all drugs for Acute Rhinosinusitis →
Sponsor
Bitop AG — full company profile →
Who can join
6 and older, any sex, with Acute Rhinosinusitis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT03480100
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Xylometazoline Nasal Spray
Trials testing the same drug.
- NCT03693976 — Non-interventional Study With Ectoin Containing and/or Decongesting Nasal Spray in Patients With Rhinosinusitis · completed
Other Bitop AG trials
Trials by the same sponsor.
- NCT05699941 — Multicentre Post-market Study of Ectoin® Inhalation Solution in Treatment of Asthma. · NA · completed
- NCT04910906 — Non-Interventional Multicentre Post-market Study of Ectoin® Vaginal Gel for Symptomatic Treatment of Vaginal Atrophy · completed
- NCT04203810 — Effectiveness and Tolerability of Ectoin® Mouth and Throat Spray Althaea Honey (ERS09) · NA · completed
- NCT04097327 — Effect of Ectoin Dermatitis Cream 7% on Skin Hydration and Skin Barrier Function · completed
- NCT03975257 — Ectoin Lozenges (EHT02) in the Treatment of Oropharyngeal Allergic Symptoms · NA · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03480100 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Bitop AG
- Last refreshed: 11 July 2018
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03480100.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing