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Effect of budesonide, montelukast and their combination in allergic rhinitis

Comparison of the effectiveness of intranasal budesonide, oral montelukast and their combination in patients with allergic rhinitis

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20171030037093N41
Enrollment
135
Registered
2020-11-01
Start date
2020-11-10
Completion date
Unknown
Last updated
2020-11-30

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

Conditions

Allergic rhinitis. Vasomotor and allergic rhinitis

Interventions

Intervention 1: First intervention group: treated with budesonide nasal spray by Jaber Ibn Hayyan Company (1 puff of spray 64 micrograms per nose, morning and evening
a total of 256 micrograms per day) for 3 months. Intervention 2: Second intervention group: treated with montelukast tablets produced by Tehran Daru company (1 montelukast tablet 10 mg in the evening)
a total of 128 micrograms per day) plus montelukast tablets produced by Tehran Daroo Company (1 montelukast tablets 10 mg in the evening) for 3 months.

Sponsors

Esfahan University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
15 Years to No maximum

Inclusion criteria

Inclusion criteria: Having allergic rhinitis Age over 15 years

Exclusion criteria

Exclusion criteria: smoking Pregnancy Asthma Nasal polyps Severe nasal deviation Nasal tumor or mass Sinusitis Get any treatment for allergic rhinitis within a week before the visit Existence of severe underlying disease Having Churg-Strauss

Design outcomes

Primary

MeasureTime frame
Runny nose score. Timepoint: Before intervention, 3 weeks, 6 weeks and 12 weeks after treatment. Method of measurement: Visual Analogue Scale and Sino-nasal Outcome Test questionnaires.;Sneezing score. Timepoint: Before intervention, 3 weeks, 6 weeks and 12 weeks after treatment. Method of measurement: Visual Analogue Scale and Sino-nasal Outcome Test questionnaires.;Nasal congestion score. Timepoint: Before intervention, 3 weeks, 6 weeks and 12 weeks after treatment. Method of measurement: Visual Analogue Scale and Sino-nasal Outcome Test questionnaires.;Itchy nose score. Timepoint: Before intervention, 3 weeks, 6 weeks and 12 weeks after treatment. Method of measurement: Visual Analogue Scale and Sino-nasal Outcome Test questionnaires.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAhmad Rezaeian

Esfahan University of Medical Sciences

dr.ahmadrezaeian@gmail.com+98 31 3792 7539

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026