FindTrial
Sign In

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

Comparative Evaluation Of Therapeutic Efficacy And Safety Of Intranasal Fluticasone Furoate And Fluticasone Propionate In Patients Of Chronic Rhinosinusitis: A Randomized, Open Label, Parallel Group Study - nil

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/04/064979
Enrollment
76
Registered
2024-04-01
Start date
Unknown
Completion date
Unknown
Last updated
2024-12-09

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

Conditions

Health Condition 1: J329- Chronic sinusitis, unspecified Health Condition 2: J329- Chronic sinusitis, unspecified

Interventions

Intervention1: Fluticasone Furoate: INTRANASAL STEROID 27.5 microgram- 2 puffs - 60 DAYS Control Intervention1: Fluticasone Propionate: INTRANASAL STEROID 50 microgram, 2 puffs - 60 DAYS

Sponsors

Govt Doon Medical college
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Newly diagnosed cases of chronic rhinosinusitis in age group of 18-60 years . 2. Patients giving valid informed consent.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
1. Change in Sino-Nasal Outcome Test Scores (SNOT-22) [ treatment baseline to 2 months post treatment] 2.Mean change in Nasal Obstruction Symptom Evaluation (NOSE) score [treatment baseline to 2 months post treatment] 3. Number of Participants Who Score 3 on the Clinical Global Impression Severity Scale (CGIS) [ treatment baseline to 2 months post treatment] 4. Change in Nasal Endoscopic Findings Using the Lund-Kennedy Grading System [treatment baseline to 2 months post treatment] 5. Peak Nasal Inspiratory Flow (PNIF) [treatment baseline to 2 months post treatment]Timepoint: day 0 day 30 day 60—

Secondary

MeasureTime frame
1.Causality assessment as per WHO-UMC scale. 2. Quality of life assessment using WHO QOL-BREF questionnaire.Timepoint: day 0 day 30 day 60—

Countries

India

Contacts

Public ContactDr Sanjay Gaur

Govt Doon medical college

gaursanjay75@gmail.com8384806334

Outcome results

None listed

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