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

• Status: Completed
• Trial end date: 2016-09-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Beijing Tongren Hospital
• Treatments: Budesonide; Montelukast

Criteria

Inclusion Criteria:

• moderate to severe seasonal allergic rhinitis

• confirmed to had a diagnosis of SAR and also shown to be sensitized to mugwort allergen

• had not received any therapies for AR or antibiotics for at least 7 days before their outpatient clinic visit prior to the study

Exclusion Criteria:

• smokers

• asthma (based on patient's history and pulmonary function tests)

• had any other chronic disease

• pregnant women