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NCT04203810
Effectiveness and Tolerability of Ectoin® Mouth and Throat Spray Althaea Honey (ERS09)
NA trial testing Ectoin® Mouth and Throat Spray Althaea Honey (ERS09) in Sore Throat in 194 participants. Completed in 4 December 2020.
4 December 2020
Quick facts
| Lead sponsor | Bitop AG |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 194 |
| Start date | 14 January 2020 |
| Primary completion | 4 December 2020 |
| Estimated completion | 4 December 2020 |
| Sites | 12 locations across Germany |
Drugs / interventions tested
- Ectoin® Mouth and Throat Spray Althaea Honey (ERS09)
- EMSER® Hals-und Rachenspray (throat spray)
Conditions studied
- Sore Throat — all drugs for Sore Throat →
- Acute Pharyngitis — all drugs for Acute Pharyngitis →
- Cough — all drugs for Cough →
Sponsor
Bitop AG — full company profile →
Who can join
12 and older, any sex, with Sore Throat or Acute Pharyngitis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The aim of this multicentre, actively controlled, randomized, open label, parallel group, prospective, comparator study is to collect data on the clinical effectiveness and tolerability of the medical device ERS09 compared to a well-established comparator spray in the symptomatic treatment of sore throat due to acute pharyngitis and dry cough.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
-
Effectiveness and Tolerability of Ectoin<sup>®</sup> Mouth and Throat Spray Althaea Honey (ERS09) for Sore Throat due to Acute Pharyngitis and Dry Cough: A Multicentre, Actively Controlled, Open Label Study in Germany.
Roventa DLC, Pieper-Fürst U, Acikel C, Santos D, et al · · 2023 · cited 2× · PMID 37762768 · DOI 10.3390/jcm12185813 -
Abstracts, 16. Deutscher Allergiekongress, Dresden, 30. September-2. Oktober 2021
· 2021 · cited 1× -
Abstracts of the 16th German Allergy Congress Dresden, September 30–October 2, 2021
· 2021
Verify or expand the search:
- PubMed search for NCT04203810
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Sore Throat
Currently open trials in the same condition.
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- NCT07517926 — Chewing Gum and Cold Gargle on Post-Bronchoscopy Symptoms · NA · recruiting
- NCT06967896 — Different Models of Tracheal Catheters Are Used for Female Thyroid Glands · recruiting
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
- 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
- NCT04021225 — Comparison of Ectoin® Containing Eye Drops and Ectoin® Containing Eye Spray With the Eye Spray Tears Again® · 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 NCT04203810 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- 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: 28 July 2022
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/NCT04203810.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing