| CTRI Number |
CTRI/2025/07/090164 [Registered on: 03/07/2025] Trial Registered Prospectively |
| Last Modified On: |
03/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Study Comparing Two Nasal Sprays (Mometasone and Fluticasone) in Children with Enlarged Adenoids to See Which Works Better |
|
Scientific Title of Study
|
Comparative efficacy of Mometasone Furoate versus Fluticasone Fumarate Nasal Spray Using Clinical and Radiological Scoring in Children with Adenoid Hypertrophy |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
VANDANAPU VENKATA SIR HARSHA |
| Designation |
PAEDIATRIC RESIDENT |
| Affiliation |
SRM MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTER |
| Address |
NO 03 I BLOCK, FIRST FLOOR , DEPARTMENT OF PAEDIATRICS, SRM MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE, KATTANKULATHUR CAMPUS, CHENGALPATTU DISTRICT
NO 03 I BLOCK, FIRST FLOOR , DEPARTMENT OF PAEDIATRICS, SRM MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE, KATTANKULATHUR CAMPUS, CHENGALPATTU DISTRICT
Chennai
TAMIL NADU
603203
India |
| Phone |
9441848070 |
| Fax |
|
| Email |
wwwe.harsha13@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR R PRASANNA RAJU |
| Designation |
PROFESSOR OF PAEDIATRICS |
| Affiliation |
SRM MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTER |
| Address |
NO 03 I BLOCK, FIRST FLOOR , DEPARTMENT OF PAEDIATRICS, SRM MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE, KATTANKULATHUR CAMPUS, CHENGALPATTU DISTRICT
NO 03 I BLOCK, FIRST FLOOR , DEPARTMENT OF PAEDIATRICS, SRM MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE, KATTANKULATHUR CAMPUS, CHENGALPATTU DISTRICT
Chennai
TAMIL NADU
603203
India |
| Phone |
9841114613 |
| Fax |
|
| Email |
Dr_prasannaraju@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
DR R PRASANNA RAJU |
| Designation |
PROFESSOR OF PAEDIATRICS |
| Affiliation |
SRM MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTER |
| Address |
NO 03 I BLOCK, FIRST FLOOR , DEPARTMENT OF PAEDIATRICS, SRM MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE, KATTANKULATHUR CAMPUS, CHENGALPATTU DISTRICT
NO 03 I BLOCK, FIRST FLOOR , DEPARTMENT OF PAEDIATRICS, SRM MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE, KATTANKULATHUR CAMPUS, CHENGALPATTU DISTRICT
Chennai
TAMIL NADU
603203
India |
| Phone |
9841114613 |
| Fax |
|
| Email |
Dr_prasannaraju@yahoo.com |
|
|
Source of Monetary or Material Support
|
| NO 03 I BLOCK, FIRST FLOOR , DEPARTMENT OF PAEDIATRICS, SRM MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE, KATTANKULATHUR CAMPUS, CHENGALPATTU DISTRICT,
CHENNAI,
TAMIL NADU,
603203,
INDIA |
|
|
Primary Sponsor
|
| Name |
VANDANAPU VENKATA SRI HARSHA |
| Address |
NO 03 I BLOCK, FIRST FLOOR , DEPARTMENT OF PAEDIATRICS, SRM MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTER, KATTANKULATHUR CAMPUS, CHENGALPATTU DISTRICT, TAMIL NADU |
| Type of Sponsor |
Other [SELF] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| VANDANAPU VENKATA SIR HARSHA |
SRM MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTER |
NO 03 I BLOCK, FIRST FLOOR , DEPARTMENT OF PAEDIATRICS, SRM MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE, KATTANKULATHUR CAMPUS, CHENGALPATTU DISTRICT
Chennai
TAMIL NADU |
9441848070
wwwe.harsha13@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE SRM MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J352||Hypertrophy of adenoids, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Fluticasone Fumarate Nasal Spray |
Comparing the efficacy of Mometasone furoate intranasal corticosteroid versus Fluticasone fumarate intranasal corticosteroid nasal spray before and after treatment using clinical and radiological scoring in children with adenoid hypertrophy
Glucocorticoid nasal sprays Mometasone furoate intranasal corticosteroid and Fluticasone fumarate intranasal corticosteroid nasal spray
these are newer agents sometimes called second generation are more convenient and probably safer for long term use than the older agents because of lower bioavailability
Glucocorticoid nasal sprays with low bioavailability and once daily dosing may have a advantage in children
Mometasone furoate and Fluticasone fumarate are approved by the US FDA for use in children more than or equal to 2 years of age
Second-generation systemic bioavailability less than 1 percent or undetectable |
| Intervention |
Mometasone Furoate Nasal Spray |
Comparing the efficacy of Mometasone furoate intranasal corticosteroid versus Fluticasone fumarate intranasal corticosteroid nasal spray before and after treatment using clinical and radiological scoring in children with adenoid hypertrophy
Glucocorticoid nasal sprays Mometasone furoate intranasal corticosteroid and Fluticasone fumarate intranasal corticosteroid nasal spray
these are newer agents sometimes called second generation are more convenient and probably safer for long term use than the older agents because of lower bioavailability
Glucocorticoid nasal sprays with low bioavailability and once daily dosing may have a advantage in children
Mometasone furoate and Fluticasone fumarate are approved by the US FDA for use in children more than or equal to 2 years of age
Second-generation systemic bioavailability less than 1 percent or undetectable |
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
14.00 Year(s) |
| Gender |
Both |
| Details |
Children aged between 2 and 14 years who are newly diagnosed with adenoid hypertrophy, exhibiting symptoms such as snoring, mouth-breathing and obstructive breathing during sleep, and confirmed by lateral neck radiography, will be included in the study. |
|
| ExclusionCriteria |
| Details |
Immunocompromised patients, nasal structural disease, prior tonsil or adenoid surgery, craniofacial abnormalities |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Identification of the most effective intranasal corticosteroid for improving symptoms and reducing adenoid size in children with adenoid hypertrophy.
Insights into the optimal choice of intranasal corticosteroid based on clinical and radiological considerations.
|
3 months
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
14/07/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
60 Children 2- 14 years of age will be enrolled in the study with consent from the parents. Randomization followed by symptomatology scoring and radiological scoring will be done. 30 children are allocated in group A - will receiving MOMETASONE FUROATE Other 30 children are allocated in group B - will receiving FLUTICASONE FUMARATE Regular follow for adherence, compliance and complication will be done Repeat symptomatology scoring and radiological scoring will be done after 3 months and results will be compared |