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

Study Overview
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Brief Summary
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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.

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

Conditions
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Allergic Rhinitis

Intervention / Treatment
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* Drug: budesonide


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 47 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: combination of budesonide and montelukast<br>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) | Drug: budesonide<br>* SAR patients received treatment of a combination of budesonide and montelukast tablet or only intranasal budesonide randomly for 14 days<br>* Other names: montelukast;|
| Active Comparator: only intranasal budesonide<br>treatment with only intranasal budesonide 1 spray per nostril twice daily for 14 days (BD treatment group) | Drug: budesonide<br>* SAR patients received treatment of a combination of budesonide and montelukast tablet or only intranasal budesonide randomly for 14 days<br>* Other names: montelukast;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change of subjective AR symptoms | The participants were asked by one investigator to fill in a questioner detailing the presence of nasal and eye symptoms (including nasal congestion, rhinorrhea, nasal itching, sneezing and eye itching), and to score each symptom on a 0-10 cm scale; with 0 cm = no symptoms and 10 cm = most severe and bothersome symptom. The same investigator calculated both the individual symptom and the average of the sum of 5 AR symptoms scores, before and at the end of 14 days' treatment. Any subject with a mean score of < 4 cm at baseline was excluded from this study. | at baseline, 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change of objective examination: nasal patency | Eccovision acoustic rhinometry was used to measure the nasal cavity volume (NCV) according to standardized recommendations. Measurements of nasal volume were made from the first 2 cm (V2), the first 4 cm (V4), from the first 6 cm (V6), from the segment between 0 and 5 cm (V0-5), and the segment between 0 and 7 cm (V0-7) of the nose. All measurements were performed three times by the same operator, and nasal volumes were calculated as the sum of both nostrils24. In the current study, the change in the nasal cavity volume was measured at 2-5 cm, as this seems to be an important variable for mucosal changes.24 Nasal airway resistance (NAR) was measured by anterior active rhinomanometry in a quiet room at temperature of 25°C and humidity of 70%. NAR was measured at 75 Pa point (R75T). | at baseline, 14 days | 
| The change of Fractional Exhaled NO | A nitric oxide analyser was used to measure exhaled nasal nitric oxide (nNO). Briefly, NO-free air was aspirated through the nasal cavity at a flow rate of 50 ml/s. The subject exhaled against the air-resistance, resulting in an intraoral pressure to close the velum and prevent mixture of oral and nasal gas. Nasal gas from this circuit was continuously routed in part directly into the analyser for determination of nNO, and the level of nNO(ppb) was calculated from a plateau lasting for at least 3s. | at baseline, 14 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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budesonide, montelukast, combination therapy, monotherapy