Intranasal steroids alone and in combination with levocetirizine, and/or montelukast for moderate to severe allergic rhinitis in children: a randomized controlled trial
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- AIIMS NEW DELHI
- Enrollment
- 64
- Locations
- 1
- Primary Endpoint
- To determine the superiority of add-on therapy (INS+levocetirizine and/or montelukast) vs INS in children with moderate-severe allergic rhinitis
Overview
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:
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Group 1: INS plus placebo
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Group 2: INS plus montelukast
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Group 3: INS plus levocetirizine
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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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Double
Eligibility Criteria
- Ages
- 6.00 Year(s) to 14.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •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.
Exclusion Criteria
- •Recent (within last 1 month) nasal surgery.
Outcomes
Primary Outcomes
To determine the superiority of add-on therapy (INS+levocetirizine and/or montelukast) vs INS in children with moderate-severe allergic rhinitis
Time Frame: At enrollment, 4 weeks and then 8 weeks
Secondary Outcomes
- Side effects of add-on therapy.(â— Effectiveness of treatment modalities in treating specific symptoms of AR.)
Investigators
Ojasvini Bali
Department of Pediatrics