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IRCT20220218054057N1 IRCT 2023-01-24 Shiraz University of Medical Sciences Omalizumab Efficacy in Chronic Rhinosinusitis Patients with Recurrent Nasal Polyp Omalizumab Efficacy in Chronic Rhinosinusitis Patients with Recurrent and Refractory Nasal Polyps, Randomized Clinical trial 2023-01-10 anticipated 30 Complete https://irct.ir/trial/67941 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Other, Purpose: Treatment, Randomization description: One method of randomization is to use theRANDBETWEEN function in Excel. This function allows us to generate randomnumbers. To generate a random number in this study with a sample size of 30,between the two numbers 1 and 31, the function = Randbetween (1,31) is used. Thisfunction creates a column of random numbers between 1 and 31. The rand functionselects numbers with equal probability in this interval, so the chance of selecting anynumber in this interval is equal to the other numbers. This means that each patient isassigned to enter one of two treatments, respectively. These data are 30 people whoare randomly assigned to 2 treatments 1 and 2 (15 people in each group). The samplenumbers in the first group and the second are as follows:A: 15,7,6,29,23,13,10,25,12,1,4,17,26,20,11B: 28,14,21,3,8,22,2,5,16,30,27,19,18,9,24A or B could be contributed to both control and Omalizumab group.The researcher who reviews the results is not aware of the group allocation. 3 Efficacy of omalizumab in patients with Chronic rhino sinusitis and refractory nasal polyp. Intervention 1: Intervention group: The first group includes the patient group that is treated with the drug Amalizumab, which is a 150 mg recombinant anti-human IgE compound manufactured by Novartis. The drug dose is defined according to the patient's weight and IgE level according to the standard table and is injected subcutaneously every 2-4 weeks for 6 months. The patient is given the necessary training about anaphylaxis. According to the prescribed drug protocol, in the IgE range of 30-100, in the weight of 30-40k, it is 75mg, in 40-90k, in the amount of 150mg, and above 90k, in the amount of 300mg. In IgE100-200, in the weight of 30-40k, in the amount of 150mg. It is 300mg in 40-80k, 450mg in 120-90k and 600mg in 125-150k. In IgE range 200-300, in 30-40k it is 225mg and in 60-40k it is 300mg and in 60- 90k is 450mg, and above 90k is 600mg. In the IgE range of 300-400 in weight 30-40k it is 300mg, in 70-40k it is 450mg and in weight above 70 it is 600mg. IgE in the range of 400-500 is 450 mg in weight 50-30 and 600 mg in weight above 50k. In IgE above 500 in weight 50-30 it is 450 mg and in weight above 40k is 600 mg. Intervention 2: Control group: Group two of chronic rhinosinusitis patients with recurrent and resistant nasal polyps treated with standard medical drugs in which there was no intervention. Yes - There is a plan to make this available What will be shared: The data includes the demographic characteristics, and the process of scoring the symptoms, prick test and pulmonary function test of the patients. All the potential data can be shared after de-identifying the people. When: Access starts 6 months after the results are published To whom: Researchers of academic institutions Conditions: All data can be published if used to improve the treatment of patients under ethical principles. Where to obtain: Rafat Noeiaghdam - Shiraz, Namazi Hospital, Department of Immunology and Allergy - rafatnoi@sums.ac.ir-09171153977 How to obtain: After sending the application, if the research process is approved from the scientific and ethical point of view by the research vice-chancellor of Shiraz University of Medical Sciences, the data will be sent within a week. Comments:
public Rafat Noeiaghdam
Immunology and Allergy Department, Second Floor, Namazi Hospital ,Namazi Square
Shiraz Iran (Islamic Republic of) 7193613311 +98 71 3232 5500 Noi.rafat@yahoo.com Shiraz University of Medical Sciences scientific Rafat Noeiaghdam
Immunology and Allergy Department ,Namazi hospital , Namazi square
Shiraz Iran (Islamic Republic of) 7193613311 +98 71 3647 4332 rafatnoi@sums.ac.ir Shiraz University of Medical Sciences Iran (Islamic Republic of) Investigation in Namazi Hospital Immunology -Allergy Clinic Complete the informed consent form Patients aged 18-75 years Usage of intranasal corticosteroid Nasal Polyp score 2 or more Total Congestion Nasal score 2 or higher SNOT22 score 20 or higher on arrival 18 years 60 years Both The patients with other sinunasal or pulmonary disorders (except asthma) History of past or current malignancy History of a cardiac condition, hepatitis or liver cirrhosis History of recent or current infection requiring hospitalization History of recent use of immunosuppressant and biologics History of recent nasal surgery (<6 months). known allergy to omalizumab Disease of respiratory disease Treatment - Drugs Treatment - Drugs Intervention group: The first group includes the patient group that is treated with the drug Amalizumab, which is a 150 mg recombinant anti-human IgE compound manufactured by Novartis. The drug dose is defined according to the patient's weight and IgE level according to the standard table and is injected subcutaneously every 2-4 weeks for 6 months. The patient is given the necessary training about anaphylaxis. According to the prescribed drug protocol, in the IgE range of 30-100, in the weight of 30-40k, it is 75mg, in 40-90k, in the amount of 150mg, and above 90k, in the amount of 300mg. In IgE100-200, in the weight of 30-40k, in the amount of 150mg. It is 300mg in 40-80k, 450mg in 120-90k and 600mg in 125-150k. In IgE range 200-300, in 30-40k it is 225mg and in 60-40k it is 300mg and in 60- 90k is 450mg, and above 90k is 600mg. In the IgE range of 300-400 in weight 30-40k it is 300mg, in 70-40k it is 450mg and in weight above 70 it is 600mg. IgE in the range of 400-500 is 450 mg in weight 50-30 and 600 mg in weight above 50k. In IgE above 500 in weight 50-30 it is 450 mg and in weight above 40k is 600 mg. Control group: Group two of chronic rhinosinusitis patients with recurrent and resistant nasal polyps treated with standard medical drugs in which there was no intervention. Sini nasal outcome test -22. Timepoint: Day 1; and at Weeks 4, 8, 16, and 24. Method of measurement: Point range, 0-110,lower scores indicating better disease control and quality of life . The questionnaire includes 22 variables , and the severity of each item ranges from no symptoms with a score of 0 to very severe with a score of 5. Variables include the need to fan - Sneezing - Runny nose - Cough - Discharg from the back of the throat - Thick nasal discharge - Feeling full in the ears - Dizzness - Feeling pain with pressure in the ear - Feeling pain with pressure in the face - Hard sleep - Waking up in a dream Nocturnal - Lack of good night sleep - Laziness after waking up - Fatigue during the day - Low efficiency - Low concentration - Frustration and irritability - Sad - Embarrassed - Affected sense of taste or smell and blocked and stuffy nose. Shiraz University of Medical Sciences Approved 2022-07-02 Ethics committee of Shiraz University of Medical Science Namazi square ,Namazi hospital Shiraz Fars Iran (Islamic Republic of)