| CTRI Number |
CTRI/2026/01/100421 [Registered on: 06/01/2026] Trial Registered Prospectively |
| Last Modified On: |
03/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
This study compares Montelukast alone and Montelukast in combination with Levocetirizine in children aged 6 to 12 years with asthma and nasal allergy to see which treatment works better and is safer. |
|
Scientific Title of Study
|
A comparative study to evaluate the efficacy and safety of montelukast monotherapy versus montelukast plus levocetrizine combination therapy in paediatric asthma patients with allergic rhinitis. |
| 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 Amanpreet Kaur Kler |
| Designation |
Junior Resident |
| Affiliation |
Government Medical College Patiala Punjab |
| Address |
Department of Pharmacology Government Medical College Patiala Punjab
Patiala
PUNJAB
147001
India |
| Phone |
8146086733 |
| Fax |
|
| Email |
kler.aman1997@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jasbir Singh |
| Designation |
Professor and Head of Department |
| Affiliation |
Government Medical College Patiala |
| Address |
Department of Pharmacology Government Medical College Patiala Punjab
Patiala
PUNJAB
147001
India |
| Phone |
9417212020 |
| Fax |
|
| Email |
Jsjasbir9@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Amanpreet Kaur Kler |
| Designation |
Junior Resident |
| Affiliation |
Government Medical College Patiala |
| Address |
Department of Pharmacology Government Medical College Patiala Punjab
Patiala
PUNJAB
147001
India |
| Phone |
8146086733 |
| Fax |
|
| Email |
kler.aman1997@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Medical College Patiala Punjab Pincode 147001 India |
|
|
Primary Sponsor
|
| Name |
Government Medical College, Patiala |
| Address |
Government Medical College Patiala Punjab Pincode 147001 |
| 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 |
| Dr Amanpreet Kaur Kler |
Rajindra Hospital Patiala |
OPD Department of Paediatrics Unit 2 room no 1
Patiala
PUNJAB |
8146086733
kler.aman1997@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Government Medical College Patiala |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J45||Asthma, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Montelukast |
Patients with bronchial asthma with allergic rhinitis will be given only montelukast 5mg once daily orally for 8 weeks. |
| Comparator Agent |
Montelukast plus levocetrizine |
Patients with bronchial asthma with allergic rhinitis will be given a combination of montelukast 5mg plus levocetrizine 5mg once daily orally for 8 weeks. |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
1. Children aged 6 to 12 years.
2. Diagnosed with mild to moderate persistent asthma (as per GINA guidelines).
3. Diagnosed with allergic rhinitis (as per ARIA criteria).
4. Parental/guardian consent and child assent obtained for participation. |
|
| ExclusionCriteria |
| Details |
1. History of acute exacerbation of asthma requiring systemic corticosteroids in
the past 4 weeks.
2. Presence of any other chronic respiratory illness (e.g., cystic fibrosis,
tuberculosis).
3. Known hypersensitivity or contraindication to Montelukast or Levocetirizine
4. Use of immunomodulators or long-term corticosteroids within the past month. |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare the efficacy of Montelukast monotherapy versus Montelukast
Levocetirizine combination therapy in pediatric asthma patients with allergic
rhinitis using Total Nasal Symptom Score (TNSS), Spirometry and Asthma
Control Test (ACT)(32) over 8 weeks |
Visit 1 baseline
Visit 2 at end of 8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To assess treatment adherence over the 8 week period.
2. To observe and document adverse effects associated with Montelukast |
Visit 1 baseline
Visit 2 at end of 8 weeks |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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 4 |
|
Date of First Enrollment (India)
|
14/01/2026 |
| 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
|
Allergic rhinitis (AR) is a common atopic disease affecting approximately 10–30% of adults and up to 40% of children globally, while in India about 20–30% of children are affected. Bronchial asthma is a chronic inflammatory airway disease affecting around 262 million people worldwide, with a prevalence of about 2–18%, and approximately 5–7% of children in India, particularly in urban and semi-urban areas. Allergic rhinitis and bronchial asthma frequently coexist and share common inflammatory pathways, a concept described as the “united airway disease,” where involvement of the upper airway often influences lower airway disease, leading to poorer asthma control and increased exacerbations.This study will be conducted in children aged 6 to 12 years suffering from bronchial asthma with allergic rhinitis, in which a total of 70 participants will be randomly divided into two groups. One group will receive montelukast monotherapy, while the other group will receive a combination of montelukast and levocetirizine. The efficacy of treatment will be assessed by comparing Asthma Control Test (ACT) scores, Total Nasal Symptom Score (TNSS), and spirometry parameters at baseline and at 8 weeks. Safety will be evaluated by monitoring and recording any adverse drug reactions during the study period, and the outcomes of both groups will be compared to determine the more effective and safer treatment option in children. |