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.

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. - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/01/100421

Enrollment

Registered

2026-01-06

Start date

Unknown

Completion date

Unknown

Last updated

2026-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: J45- Asthma

Interventions

Intervention1: Montelukast: Patients with bronchial asthma with allergic rhinitis will be given only montelukast 5mg once daily orally for 8 weeks. Control Intervention1: Montelukast plus levocetrizin

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

Measure	Time frame
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 weeksTimepoint: Visit 1 baseline Visit 2 at end of 8 weeks	—

Secondary

Measure	Time frame
1. To assess treatment adherence over the 8 week period. 2. To observe and document adverse effects associated with MontelukastTimepoint: Visit 1 baseline Visit 2 at end of 8 weeks	—

Countries

India

Contacts

Public ContactDr Amanpreet Kaur Kler

Government Medical College Patiala

Jsjasbir9@gmail.com9417212020

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 7, 2026