Comparison of therapeutic effect and safety of intranasal fluticasone furoate and fluticasone furoate in patients of Chronic Rhinosinusitis: A Randomized, Open Label, Parallel Group Study
- Conditions
- Health Condition 1: J329- Chronic sinusitis, unspecifiedHealth Condition 2: J329- Chronic sinusitis, unspecified
- Registration Number
- CTRI/2024/04/064979
- Lead Sponsor
- Govt Doon Medical college
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1.Newly diagnosed cases of chronic rhinosinusitis in age group of 18-60 years .
2. Patients giving valid informed consent.
1. Cases having active upper air way infection, malignant / benign mass of nose and PNS and post-operative cases of functional endoscopic sinus surgery.
2. Patient having symptomatic gross Deviated Nasal Septum(DNS),Septal perforation and/or Nasal polyps, severe epistaxis, purulent nasal infection
3. Patients refusing to participate in the study.
4. Dependence on prolonged corticosteroid therapy for comorbid conditions, such as asthma and chronic obstructive pulmonary disease
5. History of allergy to fluticasone propionate or fluticasone furoate or other topical steroids.
6. History of clinically significant cardiac, renal, psychiatric, hepatic and endocrine disease.
7. Pregnant or breastfeeding females.
8. Known immunodeficiency state.
9. Patients of Fungal Rhinosinusitis.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Change in Sino-Nasal Outcome Test Scores (SNOT-22) [ treatment baseline to 2 months post treatment] <br/ ><br>2.Mean change in Nasal Obstruction Symptom Evaluation (NOSE) score [treatment baseline to 2 months post treatment] <br/ ><br>3. Number of Participants Who Score 3 on the Clinical Global Impression Severity Scale (CGIS) [ treatment baseline to 2 months post treatment] <br/ ><br>4. Change in Nasal Endoscopic Findings Using the Lund-Kennedy Grading System [treatment baseline to 2 months post treatment] <br/ ><br>5. Peak Nasal Inspiratory Flow (PNIF) [treatment baseline to 2 months post treatment]Timepoint: day 0 day 30 day 60
- Secondary Outcome Measures
Name Time Method 1.Causality assessment as per WHO-UMC scale. <br/ ><br>2. Quality of life assessment using WHO QOL-BREF questionnaire.Timepoint: day 0 day 30 day 60