Condition 1: Treatment-Resistant Chronic Rhinosinusitis with Polyps. Condition 2: Treatment-Resistant Chronic Rhinosinusitis with Polyps. Nasal polyp, unspecified Chronic sinusitis, unspecified
Conditions
Interventions
Intervention 1: Patients with chronic rhinosinusitis with nasal polyps will receive standard therapy including intranasal corticosteroids and nasal saline irrigation in addition to 0.03% tofacitinib n
Sponsors
Iran University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: Patients aged 18–60 years with chronic rhinosinusitis with nasal polyps (CRSwNP) refractory to standard therapy, exhibiting evidence of type 2 (Th2) inflammation, who presented to Hazrat Rasool Akram Hospital affiliated with Iran University of Medical Sciences during the years 1404–1405. Confirmation of the diagnosis of chronic rhinosinusitis with nasal polyps refractory to treatment based on clinical and imaging criteria, in patients who have undergone at least one nasal polypectomy within the past 7 years and whose disease is currently uncontrolled.
Exclusion criteria
Exclusion criteria: Unwillingness to participate in the study use of systemic corticosteroids or systemic antibiotics outside the study protocol pregnancy active viral infections such as hepatitis or varicella; active or latent tuberculosis concomitant autoimmune disease or malignancy lack of patient cooperation with follow-up
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction in nasal polyp size. Timepoint: At months 0, 2, 4, and 6. Method of measurement: nasal endoscopy.;Radiologic findings of sinus and airway involvement. Timepoint: At months 0, 2, 4, and 6. Method of measurement: CT scan.;Respiratory volume. Timepoint: At months 0, 2, 4, and 6. Method of measurement: Spirometry.;Use of systemic antibiotics and systemic corticosteroids. Timepoint: At months 0, 2, 4, and 6. Method of measurement: Patient self-report.;CRS symptoms (nasal obstruction, nasal discharge, and olfactory dysfunction). Timepoint: At months 0, 2, 4, and 6. Method of measurement: Patient self-report.;Extra-nasal symptoms (poor sleep, ear/facial discomfort, and mood disturbance). Timepoint: At months 0, 2, 4, and 6. Method of measurement: Patient self-report.;Quality of life score. Timepoint: At months 0, 2, 4, and 6. Method of measurement: SNOT-22 questionnaire.;Drug-related adverse effects. Timepoint: At months 0, 2, 4, and 6. Method of measurement: Patient visit and clinical examination. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactMorteza Fallahpour
Iran University of Medical Sciences
Outcome results
None listed