Impaired sense of smell and its conservative tratment in patients with chronic rhinosinusitis

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2010-024438-52-CZ

Enrollment

Registered

2011-08-02

Start date

2011-09-05

Completion date

Unknown

Last updated

2024-07-29

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

Conditions

The proposed clinical study on impaired sense of smell in patients with chronic rhinosinusitis.

Interventions

Trade Name: Prednison Zentiva 5 mg Product Name: Prednison - prednisonum Product Code: H02AB07 Pharmaceutical Form: Tablet INN or Proposed INN: PREDNISONE CAS Number: 53-03-2 Pharmaceutical form of th

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: patients with chronic rhinosinusitis, age over 18, impaired sense of smell (TDI - score (treshold/discrimination/identification) in Sniffing sticks test equals or lower than 25) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 50 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: diabetes mellitus, not impaired sense of smell (TDI over 25), exclusion criteria of prednison uptake, previous corticostroid treatment, gravidity

Design outcomes

Primary

Measure	Time frame
Main Objective: if treatment with prednisone in patients with chronic rhinosinusitis is more effective on impaired sense of smell than placebo;Secondary Objective: none;Primary end point(s): is prednisone effective more than placebo;Timepoint(s) of evaluation of this end point: 50 patients, duration 6-12 months	—

Secondary

Measure	Time frame
Secondary end point(s): None;Timepoint(s) of evaluation of this end point: 50 patients, duration 6-12 months	—

Countries

Czech Republic

Contacts

Public ContactMUDr. Simona Simonidesová

Fakultní nemocnice v Motole

simona.simonidesova@fnmotol.cz+420727971892

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026