Impaired sense of smell and its conservative tratment in patients with chronic rhinosinusitis
Phase 1
- Conditions
- The proposed clinical study on impaired sense of smell in patients with chronic rhinosinusitis.Therapeutic area: Diseases [C] - Ear, nose and throat diseases [C09]
- Registration Number
- EUCTR2010-024438-52-CZ
- Lead Sponsor
- Fakultní nemocnice v Motole
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 50
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
diabetes mellitus, not impaired sense of smell (TDI over 25), exclusion criteria of prednison uptake, previous corticostroid treatment, gravidity
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Secondary end point(s): None;Timepoint(s) of evaluation of this end point: 50 patients, duration 6-12 months