Non-interventional study and study according to §23b German Act on Medical Devices - The use of alpha-tocopherolacetate (Filme Nasale)-nasal spray in patients with pollen-induced allergic rhinitis

Non-interventional study and study according to §23b German Act on Medical Devices - The use of alpha-tocopherolacetate (Filme Nasale)-nasal spray in patients with pollen-induced allergic rhinitis - PA/Filme Nasale/D/2015

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00009338

Enrollment

120

Registered

2015-09-29

Start date

2015-04-27

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

J30.1

Interventions

Group 1: Treatment of the allergic rhinitis with Filme Nasale-nasal spray Duration of treatment: 1 week, Frequency and dose: 2 squirts in each nostril at least 3 times a day as often as required (up t

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Pollen-induced allergic rhinitis

Exclusion criteria

Exclusion criteria: According to the summary of product informations

Design outcomes

Primary

Measure	Time frame
The efficacy of Filme Nasale- (alpha-Tocopherolacetat-, Vitamin E-Acetat-) nasal spray will be investigated in comparison to Beclometason-nasal spray and Loratadin-tablets. The efficacy will be evaluated on the basis of the allergic symptoms and the intake of anti-allergic medication as documented in the diary (day 1 to 7).	—

Secondary

Measure	Time frame
The tolerability of the therapy will be evaluated by means of the rhinoscopy (Visit 1 on day 1 and vistit 2 on day 7), the documentation of adverse events (visit 2) and the assessment of the physician and patient (visit 2), respectively.	—

Countries

Germany

Contacts

Public ContactRalph Mösges

Institut für Medizinische Informatik, Statistik und EpidemiologieUniklinik Köln

ralph.moesges@uni-koeln.de0221 478 82929

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 23, 2026