| CTRI Number |
CTRI/2024/09/073324 [Registered on: 04/09/2024] Trial Registered Prospectively |
| Last Modified On: |
26/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A STUDY TO FIND OUT THE EFFECT OF INJECTION OMALIZUMAB AS COMPARED TO NASAL CORTICOSTEROIDS AND ANTIHISTAMINICS ON ADENOID
HYPERTROPHY IN PEDIATRIC PATIENTS |
|
Scientific Title of Study
|
A RANDOMISED CONTROLLED PILOT STUDY TO EVALUATE THE EFFECT OF SYSTEMIC OMALIZUMAB AS COMPARED TO THAT OF NASAL CORTICOSTEROIDS AND ANTIHISTAMINICS ON ADENOID
HYPERTROPHY IN SYMPTOMATIC PEDIATRIC PATIENTS |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR MANPREET |
| Designation |
JUNIOR RESIDENT ACADEMIC |
| Affiliation |
AIIMS NEW DELHI |
| Address |
ROOM NO 4057, 4th FLOOR TEACHING BLOCK, ACADEMIC SECTION, AIIIMS NEW DELHI
ROOM NO 4057, 4th FLOOR TEACHING BLOCK, ACADEMIC SECTION, AIIIMS NEW DELHI
New Delhi
DELHI
110029
India |
| Phone |
8219810012 |
| Fax |
|
| Email |
manpreethp121@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR PREM SAGAR |
| Designation |
ADDITIONAL PROFESSOR |
| Affiliation |
AIIMS NEW DELHI |
| Address |
ROOM NO 4057, 4th FLOOR TEACHING BLOCK, ACADEMIC SECTION, AIIIMS NEW DELHI
ROOM NO 4057, 4th FLOOR TEACHING BLOCK, ACADEMIC SECTION, AIIIMS NEW DELHI
New Delhi
DELHI
110029
India |
| Phone |
9868078734 |
| Fax |
|
| Email |
sagardrprem@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR MANPREET |
| Designation |
JUNIOR RESIDENT ACADEMIC |
| Affiliation |
AIIMS NEW DELHI |
| Address |
ROOM NO 4057, 4th FLOOR TEACHING BLOCK, ACADEMIC SECTION, AIIIMS NEW DELHI
ROOM NO 4057, 4th FLOOR TEACHING BLOCK, ACADEMIC SECTION, AIIIMS NEW DELHI
New Delhi
DELHI
110029
India |
| Phone |
8219810012 |
| Fax |
|
| Email |
manpreethp121@gmail.com |
|
|
Source of Monetary or Material Support
|
| ICMR and AIIMS Research section |
|
|
Primary Sponsor
|
| Name |
AIIMS DELHI |
| Address |
AIIMS DELHI, ANSARI NAGAR, ANSARI NAGAR EAST,NEW DELHI , DELHI 110029 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| DR MANPREET |
AIIMS NEW DELHI |
ENT OPD 6TH FLOOR A WING, PEDIATRIC OPD 2ND FLOOR C WING,
PULMONARY MEDICINE OPD 5TH FLOOR A WING,
NEW RAJKUMARI AMRIT KAUR BUILDING
New Delhi
DELHI |
8219810012
manpreethp121@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTE ETHICS COMMITTEE FOR POT GRADUATE RESEARCH |
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 |
Nasal corticosteroid and oral antihistaminics |
Aqueous solution of momentasone furoate nasal spray 2 puffs OD for 12 weeks
Cetrizine dose based on age for 4 weeks |
| Intervention |
Omalizumab |
Inj Omalizumab subcutaneously 4 weekly for 3 doses dose based on body weight and serum IgE levels |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
14.00 Year(s) |
| Gender |
Both |
| Details |
Age 5 to 14 years
Symptomatic adenoid hypertrophy with at least one of these symptoms like mouth breathing or snoring or nasal obstruction or OSA or OME or recurrent ASOM or sinusitis and grade 3 or 4 adenoid hypertrophy
Serum IgE levels more than 50 IU per mL with or without allergic symptoms like excessive sneezing or rhinorrhea or atopy or itching |
|
| ExclusionCriteria |
| Details |
Obstructive sleep apnoea with Pulmonary hypertension or cor pulmonale
Lysosomal storage disorders or any other diseases which mandate urgent need for surgical intervention for adenoid hypertrophy
Adenoid hypertrophy and serous otitis media resulting in sensorineural hearing loss |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Evaluation of the effect of nasal steroids and oral antihistaminics vs parenteral omalizumab on the nasopharyngoscopic findings in pediatric patients with symptomatic adenoid hypertrophy |
Baseline, 3 months and 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Evaluation of the effect of nasal steroids and oralantihistaminics vs parenteral omalizumab on symptomatology. |
3 months |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
10/09/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
10/09/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
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
|
Though medical treatment is available for symptomatic patients with adenoid hypertrophy, a significant proportion of them ultimately need surgical removal of this lymphoid tissue which plays a significant protective role against upper airway infections, especially in pediatric patients. There is lack of research on the possible therapeutic effect of omalizumab on adenoid hypertrophy which might provide long term shrinkage in the size of the adenoid tissue avoiding surgical intervention. We therefore intent to evaluate the effect of systemic Omalizumab on adenoid hypertrophy as compared to the current medical management by nasal steroid spray along with oral antihistamine drugs |