Compare the Effect of INS Alone and Added LTRA in Treatment of SAR
Keywords
Abstract
Dates
Last Verified: | 08/31/2019 |
First Submitted: | 08/31/2019 |
Estimated Enrollment Submitted: | 08/31/2019 |
First Posted: | 09/03/2019 |
Last Update Submitted: | 08/31/2019 |
Last Update Posted: | 09/03/2019 |
Actual Study Start Date: | 05/31/2016 |
Estimated Primary Completion Date: | 09/29/2016 |
Estimated Study Completion Date: | 09/29/2016 |
Condition or disease
Intervention/treatment
Drug: budesonide
Phase
Arm Groups
Arm | Intervention/treatment |
---|---|
Experimental: combination of budesonide and montelukast 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) | |
Active Comparator: only intranasal budesonide treatment with only intranasal budesonide 1 spray per nostril twice daily for 14 days (BD treatment group) |
Eligibility Criteria
Ages Eligible for Study | 18 Years To 18 Years |
Sexes Eligible for Study | All |
Accepts Healthy Volunteers | Yes |
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 |
Outcome
Primary Outcome Measures
1. The change of subjective AR symptoms [at baseline, 14 days]
Secondary Outcome Measures
1. The change of objective examination: nasal patency [at baseline, 14 days]
2. The change of Fractional Exhaled NO [at baseline, 14 days]