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

NCT ID: NCT04077892

Last Updated: 2019-09-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-06-01
• Study Completion Date: 2016-09-30

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.

Conditions

Allergic Rhinitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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)

Group Type: EXPERIMENTAL

budesonide

Intervention Type: DRUG

SAR patients received treatment of a combination of budesonide and montelukast tablet or only intranasal budesonide randomly for 14 days

only intranasal budesonide

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

Group Type: ACTIVE_COMPARATOR

budesonide

Intervention Type: DRUG

SAR patients received treatment of a combination of budesonide and montelukast tablet or only intranasal budesonide randomly for 14 days

Interventions

budesonide

SAR patients received treatment of a combination of budesonide and montelukast tablet or only intranasal budesonide randomly for 14 days

Intervention Type: DRUG

Other Intervention Names

montelukast

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 47 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing Tongren Hospital

OTHER

Sponsor Role: lead

Responsible Party

Luo Zhang

President,Beijing TongRen Hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Zhang Luo

Role: PRINCIPAL_INVESTIGATOR

Beijing Institute of Otolaryngology

Locations

Beijing Tongren Hospital

Beijing, Beijing Municipality, China

Countries

China

References

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

PMID: 16154642 (View on PubMed)

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Reference Type: BACKGROUND

PMID: 10065672 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 16936238 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 15817806 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 16218509 (View on PubMed)

Other Identifiers

TR-INS&LTRA-AR

Identifier Type: -

Identifier Source: org_study_id