Chronic Rhinosinustis With Polyps Clinical Trial
Official title:
Ciclesonide vs Fluticasone Propionate Nasal Sprays in Patients With Nasal Poplyposis; a Randomized Clinical Trial
This study is designed to compare ciclesonide nasal spray once daily with fluticasone propionate aquas nasal spray BD, which is commonly prescribed in patients with nasal polyposis, in order to relieve symptoms of these patients.
The study will be conducted in a tertiary ENT center in Tehran. Endoscopic severity grades
for patients will be determined for polyps on the basis of 3 point classification system: 1,
confined to middle meatus; 2, below level of middle turbinate; 3, causing total obstruction.
Also, patients will be undergone paranasal sinus CT scan to determine Lund-Mackay stage
which defined by sum of scores of each of 12 paranasal sinuses (0 for a completely lucent, 1
for a partially opaque and 2 for a completely opaque sinus). Patients will be randomized to
treat in one of two groups: 1 month of therapy with fluticasone propionate aqueous nasal
spray (FPANS) 200 µg twice a day or 1 month of therapy with intranasal ciclesonide spray 200
µg once daily. All patients will be given written, easy to understand instruction about how
to use nasal sprays. All included patients are asked to answer the disease specific Persian
language validated SNOT20 quality of life questionnaire to evaluate symptom severity before
starting the treatment. SNOT20 is a symptom severity and health related quality of life
measure in sinonasal diseases that contains 20 questions about CRS related symptoms.
Symptoms severity is scored 0, indicating no problem to 5, indicating worst possible
symptom. Then scores of each of 20 items will be added to produce a total score ranging from
0 to 100. After one month of treatment patients will be visited by a blind physician to
assess the symptoms. Then patients will answer the SNOT20 questionnaire again. Patients will
be given a chance to report any problem during drug administration and enquired about
adverse effects at the end of 1 month of treatment by the physician. Withdrawals is defined
as any drug or study discontinuation due to adverse effects or lack of efficacy.
By considering 5% level of significance, to have 90% power to detect a clinically important
difference of 0.6 points between two groups in improving total score of SNOT20 assuming a
standard deviation (SD) of 0.6, we should include 22 cases in each study arm. To address a
10% probable loss to follow up, we would recruit 24 cases in each arm.
The continuous variables will be shown as mean ± SD. The categorical variables will be
presented as frequency and percentage. The normality of measure outcome variables will be
tested graphically as well as statistically with the Shapiro-Wilk test. In case of normal
distribution we would use parametric t-test to compare the mean values between two groups.
Otherwise we would use non-parametric Mann-Whitney test. Chi-squared or Fischer-exact tests
will be used to compare categorical variables. All the statistical analyses will be
conducted using IBM SPSS statistics for Windows, version 23.0, (Armonk, NY: IBM Corp.).
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment