Ciclesonide vs Fluticasone Nasal Sprays in Nasal Poplyposis
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|ClinicalTrials.gov Identifier: NCT02665806|
Recruitment Status : Unknown
Verified January 2016 by Mohsen Naraghi, Tehran University of Medical Sciences.
Recruitment status was: Not yet recruiting
First Posted : January 28, 2016
Last Update Posted : January 28, 2016
|Condition or disease||Intervention/treatment||Phase|
|Chronic Rhinosinustis With Polyps||Drug: Ciclesonide Drug: Fluticasone||Phase 3|
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.).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||32 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Ciclesonide vs Fluticasone Propionate Nasal Sprays in Patients With Nasal Poplyposis; a Randomized Clinical Trial|
|Study Start Date :||January 2016|
|Estimated Primary Completion Date :||February 2016|
|Estimated Study Completion Date :||March 2016|
intranasal ciclesonide spray 200 µg once daily
|Active Comparator: Fluticasone||
fluticasone propionate aqueous nasal spray 200 µg twice a day
- SNOT20 score difference [ Time Frame: 1 Month ]The change from the baseline in SNOT20 total score after the treatment period
- SNOT20 score difference in variuos endoscopic grades [ Time Frame: 1 Month ]The change from the baseline in SNOT20 total score after the treatment period in patients with various endoscopic grades
- SNOT20 score difference in variuos Lund-Mackay score [ Time Frame: 1 Month ]The change from the baseline in SNOT20 total score after the treatment period in patients with various paranasanl sinus CT Scan's Lund-Mackay scores
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02665806
|Contact: Salar Tofighi, MDfirstname.lastname@example.org|
|Contact: Saeed Soleymanjahi, MDemail@example.com|
|Principal Investigator:||Mohsen Naraghi, MD||Tehran University of Medical Sciences, Department of Otolaryngology-Head and Neck Surgery, Tehran, Iran|