Clinical trial NCT04077892: Compare the Effect of INS Alone and Added LTRA in Treatment of SAR
Official title: A Randomized Trial of Comparing a Combination of Montelukast and Budesonide With Budesonide in Allergic Rhinitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Allergic Rhinitis
Keywords: budesonide
montelukast
combination therapy
monotherapy
Lead sponsor: Beijing Tongren Hospital
Sponsor class: OTHER
First posted: 2019-09-04
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 47
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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

Primary outcomes:
measure: The change of subjective AR symptoms
timeFrame: at baseline, 14 days
Secondary outcomes:
measure: The change of objective examination: nasal patency
timeFrame: at baseline, 14 days
measure: The change of Fractional Exhaled NO
timeFrame: at baseline, 14 days
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tongren Hospital
state: Beijing
Study officials:
affiliation: Beijing Institute of Otolaryngology
name: Zhang Luo
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Taylor DR, Pijnenburg MW, Smith AD, De Jongste JC. Exhaled nitric oxide measurements: clinical application and interpretation. Thorax. 2006 Sep;61(9):817-27. doi: 10.1136/thx.2005.056093.
citation: American Thoracic Society; European Respiratory Society. ATS/ERS recommendations for standardized procedures for the online and offline measurement of exhaled lower respiratory nitric oxide and nasal nitric oxide, 2005. Am J Respir Crit Care Med. 2005 Apr 15;171(8):912-30. doi: 10.1164/rccm.200406-710ST. No abstract available.
citation: Clement PA, Gordts F; Standardisation Committee on Objective Assessment of the Nasal Airway, IRS, and ERS. Consensus report on acoustic rhinometry and rhinomanometry. Rhinology. 2005 Sep;43(3):169-79.