Effect and Comparison Between Combine Therapy by Mometasone Furoate and Azelastine with Single Therapy by Mometazone Furoate or Azelastine on Adenoid Size and Obstructive Symptoms in Patients Referring to ENT Clinic
Effect and Comparison Between Combine Therapy by Mometasone Furoate and Azelastine with Single Therapy by Mometazone Furoate or Azelastine on Adenoid Size and Obstructive Symptoms
Design
The first group receives spray Mometasone, the second group receives Azelastine and the third group receives Mometasone and Azelastine; 1 puff in each nostril twice a day during 30 days. A randomized double-blind clinical trial is conducted on 120 patients undergoing surgery with spinal anesthesia.
Settings and conduct
Patients are referred to ENT clinic of al-Zahra hospital. The patients are randomly divided into three groups including those who receive Mometasone (a), Azelastine (b) and Mometasone and Azelastine (c). The Participants, Care provider, Outcome assessor, and Data analyser are not aware of the drug type and the investigator deciphers the codes after data analysis.
Participants/Inclusion and exclusion criteria
Included criteria: 6 to 12 years old; Children With Hypertrophy of Adenoid Grade 3 and 4 According to Cassano Grading Excluded criteria: History of Adenoidectomy
Intervention groups
They are divided into three groups A, B, and C. The first group Mometasone, the second group received Azelastine and third group received Mometasone and Azelastine
Main outcome variables
Obstruction stmptoms and size of Adenoid
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200612047740N1
Registration date:2020-06-23, 1399/04/03
Registration timing:prospective
Last update:2020-06-23, 1399/04/03
Update count:0
Registration date
2020-06-23, 1399/04/03
Registrant information
Name
Hossein Naderi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3568 5233
Email address
hossein.naderi1374@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-07-05, 1399/04/15
Expected recruitment end date
2020-09-21, 1399/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect and Comparison Between Combine Therapy by Mometasone Furoate and Azelastine with Single Therapy by Mometazone Furoate or Azelastine on Adenoid Size and Obstructive Symptoms in Patients Referring to ENT Clinic
Public title
Effect of Combine Therapy by Mometasone Furoate and Azelastine with Single Therapy by Mometazone Furoate or Azelastine on Adenoid Size and Obstructive Symptoms in Patients Referring to ENT Clinic
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
6 to 12 Years old
Children With Hypertrophy of Adenoid Grade 3 and 4 According to Cassano Grading
Exclusion criteria:
Age
From 6 years old to 12 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are Randomly Assigned to the Groups of A, B and C Using Randomization Software
Blinding (investigator's opinion)
Double blinded
Blinding description
Nurse Participating in this Study, Give each Patient Code A, B and C According to Patients Number and classification. Doctor Checking Complications is not Aware of Using Drugs. Also Information Inserts to SPSS in the Form of Code and analyzer is Blind to the Classifications. All Drugs are Prepared and Placed at the Same Volume and Homogeneously by Investigator
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Hezar jarib
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2020-03-13, 1398/12/23
Ethics committee reference number
IR.MUI.MED.REC.1398.713
Health conditions studied
1
Description of health condition studied
Obstruction Symptoms and Size of Adenoid
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Obstructive Sleep Apnea
Timepoint
At the Beginning and End of 30 Days Treatment Duration
Method of measurement
Berlucchi Grading
2
Description
Night Snoring
Timepoint
At the Beginning and End of 30 Days Treatment Duration
Method of measurement
Berlucchi Grading
3
Description
Cough
Timepoint
At the Beginning and End of 30 Days Treatment Duration
Method of measurement
Berlucchi Grading
4
Description
Rhinorrhea
Timepoint
At the Beginning and End of 30 Days Treatment Duration
Method of measurement
Berlucchi Grading
5
Description
Nasal obstruction
Timepoint
At the Beginning and End of 30 Days Treatment Duration
Method of measurement
Berlucchi Grading
6
Description
Adenoid size/nasopharyngeal depth ratio
Timepoint
At the Beginning and End of 30 Days Treatment Duration
Method of measurement
Lateral Nasopharynx Radiography
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group A: Initially, personal consent is obtained from the patients. Then nasal spray of Mometasone is used in each nostril, 1 puff, twice a day (50 micro gram in each puff) overally 200 micro gram a day for 30 days and obstructive symptoms is evaluated in the beginning and end of the treatment period
Category
Treatment - Drugs
2
Description
Intervention group B: Initially, personal consent is obtained from the patients. Then nasal spray of Azelastine is used in each nostril, 1 puff, twice a day (125 micro gram in each puff) overally 500 micro gram a day for 30 days and obstructive symptoms is evaluated in the beginning and end of the treatment period
Category
Treatment - Drugs
3
Description
Intervention group C : Initially, personal consent is obtained from the patients. Then nasal spray of Azelastine and Mometasone is used in each nostril, 1 puff, twice a day for 30 days and obstructive symptoms is evaluated in the beginning and end of the treatment period
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Al Zahra hospital
Full name of responsible person
Hossein Ghazavi
Street address
Soffeh boulivard, Shahid Kesari highway
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
hossein.naderi1374@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr Shaghyegh Haghjoo
Street address
Hezar jarib
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
research@mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Jamileh Haghirzavare
Position
Medical student/ Intern
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Hezar Jerib
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 9801
Email
jhaghirzavareh@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Hossein Ghazavi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Hezar Jarib
City
Isfahan
Province
Isfehan
Postal code
81745185
Phone
0098316683554
Email
hossein.naderi1374@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Hossein Ghazavi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Hezar Jerib
City
Isfahan
Province
Isfehan
Postal code
81745185
Phone
0098316683554
Email
hossein.naderi1374@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
Only registered symptoms can be published without mentioning the names of the participants
When the data will become available and for how long
Starting the access period 6 months after printing results
To whom data/document is available
Only available to scholars working in academia and academia
Under which criteria data/document could be used
Written request via email and university approval
From where data/document is obtainable
By contacting the corresponding author
What processes are involved for a request to access data/document
After the email is received by the applicant, it takes one week to agree The university will be obtained and then will be notified to the requestor. Maximum of this process takes ten days.