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

Capital Medical University

Status and phase: Completed; Early Phase 1

Conditions: Allergic Rhinitis

Treatments: Drug: budesonide

Study type: Interventional

Funder types: Other

Identifiers

NCT04077892

TR-INS&LTRA-AR

Details and patient eligibility

About

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.

Enrollment: 46 patients

Sex: All

Ages: 18 to 47 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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46 participants in 2 patient groups

combination of budesonide and montelukast

Experimental group

Description:

receive treatment with either a combination of budesonide (Rhinorcort Astra Zeneca AB), 1 spray per nostril twice daily (total 256 μg/d) and 10mg oral montelukast tablet (Merck Sharp \& Dohme Australia Pty Ltd) in the evening for 14 days (BD+MNT treatment group)

Treatment:

Drug: budesonide

only intranasal budesonide

Active Comparator group

Description:

treatment with only intranasal budesonide 1 spray per nostril twice daily for 14 days (BD treatment group)

Treatment:

Drug: budesonide