| CTRI Number |
CTRI/2025/01/079369 [Registered on: 24/01/2025] Trial Registered Prospectively |
| Last Modified On: |
23/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Intranasal steroids alone and in combination with levocetirizine, and/or montelukast for moderate to severe allergic rhinitis in children |
|
Scientific Title of Study
|
Intranasal steroids alone and in combination with levocetirizine, and/or montelukast for moderate to severe allergic rhinitis in children: a randomized controlled trial
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ojasvini Bali |
| Designation |
Junior Resident PG |
| Affiliation |
Department of Pediatrics |
| Address |
Department of Pediatrics
AIIMS New Delhi
Sri Aurobindo Marg, Ansari Nagar, Ansari Nagar East, New Delhi, Delhi 110029
South
DELHI
110029
India |
| Phone |
|
| Fax |
|
| Email |
baliojasvini@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kana Ram Jat |
| Designation |
Additional Professor |
| Affiliation |
AIIMS NEW DELHI |
| Address |
Department of Pediatrics
AIIMS New Delhi
Sri Aurobindo Marg, Ansari Nagar, Ansari Nagar East, New Delhi, Delhi 110029
South
DELHI
110029
India |
| Phone |
919868152426 |
| Fax |
|
| Email |
drkanaram@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kana Ram Jat |
| Designation |
Additional Professor |
| Affiliation |
AIIMS NEW DELHI |
| Address |
Department of Pediatrics
AIIMS New Delhi
Sri Aurobindo Marg, Ansari Nagar, Ansari Nagar East, New Delhi, Delhi 110029
South
DELHI
110029
India |
| Phone |
919868152426 |
| Fax |
|
| Email |
drkanaram@gmail.com |
|
|
Source of Monetary or Material Support
|
| AIIMS New Delhi, 110049,
India |
|
|
Primary Sponsor
|
| Name |
AIIMS NEW DELHI |
| Address |
Sri Aurobindo Marg, Ansari Nagar, Ansari Nagar East, New Delhi, Delhi 110029 |
| Type of Sponsor |
Government medical college |
|
|
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 |
| Ojasvini Bali |
AIIMS NEW DELHI |
Ward 5B, Mother Child Block, 5 th floor, AIIMS, Sri Aurobindo Marg, Ansari Nagar, Ansari Nagar East, New Delhi, Delhi 110029
New Delhi
DELHI |
9891614021
baliojasvini@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of AIIMS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J309||Allergic rhinitis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Combination therapy of Intranasal steroid plus montelukast or/and Levocetrizine |
Group 2: Intranasal steroid plus montelukast syrup
Group 3: Intranasal steroid plus Levocetrizine
Group 4: Intranasal steroid plus montelukast and cetrizine syrup |
| Comparator Agent |
Intranasal steroid plus placebo syrup |
Children in all groups will receive Mometasone furoate nasal spray as 50 microgram (one spray) per nostril once a day (6-12 years) and 100 microgram (two spray) per nostril once a day (13-14 years). All patients will receive intranasal steroids (mometasone nasal spray) in similar looking formulation from the same company.
In addition, they will receive the following interventions as per their group
|
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
14.00 Year(s) |
| Gender |
Both |
| Details |
Children with moderate to severe allergic rhinitis with i) two out of four cardinal symptoms of itching, sneezing, rhinorrhea and nasal block. ii) with symptoms moderate to severe in intensity-sleep disturbance, impaired sleep, impaired work/school |
|
| ExclusionCriteria |
| Details |
Recent (within last 1 month) nasal surgery
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Double Blind Double Dummy |
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Primary Outcome
|
| Outcome |
TimePoints |
| To determine the superiority of add-on therapy (INS+levocetirizine and/or montelukast) vs INS in children with moderate-severe allergic rhinitis |
At enrollment, 4 weeks and then 8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Side effects of add-on therapy.
â— Effectiveness of treatment modalities in treating specific symptoms of AR.
â— Efficacy of the interventions on asthma control.
â— Change on FeNO with the interventions.
â— Night nasal symptoms
Efficacy in children with positive and negative skin prick test.
|
4 weeks and 8 weeks |
|
|
Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
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)
|
05/02/2025 |
| 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="6"
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
|
We plan to determine the superiority of combination therapy (INS+levocetirizine and/or montelukast) vs INS alone in children with moderate-severe allergic rhinitis in the age group of 6 years to 14 years. There is paucity of data on management of allergic rhinitis in the pediatric population. A double-blind, superiority, randomized control trial with 64 participants, divided into four arms with 16 participants each. Patients will be randomized into four groups: 1. Group 1: INS plus placebo 2. Group 2: INS plus montelukast 3. Group 3: INS plus levocetirizine 4. Group 4: INS plus montelukast plus levocetirizine Efficacy of each of these interventions in the management of allergic rhinitis will be assessed by calculating effect on total nasal symptom score.
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