NCT04077892

Compare the Effect of INS Alone and Added LTRA in Treatment of SAR

A Randomized Trial of Comparing a Combination of Montelukast and Budesonide With Budesonide in Allergic Rhinitis

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 46 (actual)
• Sponsor: Beijing Tongren Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 47 Years
• Healthy volunteers: Not accepted

Summary

It is not proven unequivocally whether a combination of an intranasal corticosteroids (INS) and a cysteinyl leukotriene receptor antagonist has greater efficacy than INS in the treatment of severe allergic rhinitis (AR) . We performed a randomized, open-label study in 46 seasonal AR subjects receiving budesonide (BD, 256ug) plus montelukast (MNT, 10 mg) or BD alone (256ug) for 2 weeks. Visual analog scale (VAS) scores, nasal cavity volume (NCV), nasal airway resistance (NAR) and fractional exhaled nitric oxide (FeNO) were assessed before and at end of treatments as the primary treatment outcomes. Similarly, histamine, eosinophil cationic protein (ECP) and cysteinyl-leukotrienes (Cyslts) in nasal secretion and Th1/Th2 cells in nasal mucosa were evaluated as the secondary treatment outcomes.

Conditions

• Allergic Rhinitis

Interventions

Type	Name	Description
DRUG	budesonide	SAR patients received treatment of a combination of budesonide and montelukast tablet or only intranasal budesonide randomly for 14 days

Timeline

• Start date: 2016-06-01
• Primary completion: 2016-09-30
• Completion: 2016-09-30
• First posted: 2019-09-04
• Last updated: 2019-09-04

Locations

1 site across 1 country: China