NCT04077892

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P50-P75 for early_phase_1

Timeline
Completed

Started Jun 2016

Shorter than P25 for early_phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2016

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

September 1, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 4, 2019

Completed
Last Updated

September 4, 2019

Status Verified

September 1, 2019

Enrollment Period

4 months

First QC Date

September 1, 2019

Last Update Submit

September 1, 2019

Conditions

Allergic Rhinitis

Keywords

budesonidemontelukastcombination therapymonotherapy

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • The change of objective examination: nasal patency

    at baseline, 14 days

  • The change of Fractional Exhaled NO

    at baseline, 14 days

Study Arms (2)

combination of budesonide and montelukast

EXPERIMENTAL

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

only intranasal budesonide

ACTIVE COMPARATOR

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

Drug: budesonide

Interventions

budesonideDRUG

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

Also known as: montelukast
combination of budesonide and montelukastonly intranasal budesonide

Eligibility Criteria

Age18 Years - 47 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • smokers
  • asthma (based on patient's history and pulmonary function tests)
  • had any other chronic disease
  • pregnant women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Tongren Hospital

Beijing, Beijing Municipality, 100730, China

Location

Related Publications (7)

  • Price DB, Swern A, Tozzi CA, Philip G, Polos P. Effect of montelukast on lung function in asthma patients with allergic rhinitis: analysis from the COMPACT trial. Allergy. 2006 Jun;61(6):737-42. doi: 10.1111/j.1398-9995.2006.01007.x.

    PMID: 16677244BACKGROUND

  • Brozek JL, Bousquet J, Baena-Cagnani CE, Bonini S, Canonica GW, Casale TB, van Wijk RG, Ohta K, Zuberbier T, Schunemann HJ; Global Allergy and Asthma European Network; Grading of Recommendations Assessment, Development and Evaluation Working Group. Allergic Rhinitis and its Impact on Asthma (ARIA) guidelines: 2010 revision. J Allergy Clin Immunol. 2010 Sep;126(3):466-76. doi: 10.1016/j.jaci.2010.06.047.

    PMID: 20816182BACKGROUND

  • Priftis KN, Drigopoulos K, Sakalidou A, Triga M, Kallis V, Nicolaidou P. Subjective and objective nasal obstruction assessment in children with chronic rhinitis. Int J Pediatr Otorhinolaryngol. 2006 Mar;70(3):501-5. doi: 10.1016/j.ijporl.2005.07.027. Epub 2005 Sep 9.

    PMID: 16154642BACKGROUND

  • Henriksen AH, Sue-Chu M, Holmen TL, Langhammer A, Bjermer L. Exhaled and nasal NO levels in allergic rhinitis: relation to sensitization, pollen season and bronchial hyperresponsiveness. Eur Respir J. 1999 Feb;13(2):301-6. doi: 10.1034/j.1399-3003.1999.13b14.x.

    PMID: 10065672BACKGROUND

  • 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.

    PMID: 16936238BACKGROUND

  • 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.

    PMID: 15817806BACKGROUND

  • 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.

    PMID: 16218509BACKGROUND

MeSH Terms

Conditions

Rhinitis, Allergic

Interventions

Budesonidemontelukast

Condition Hierarchy (Ancestors)

RhinitisNose DiseasesRespiratory Tract DiseasesRespiratory HypersensitivityOtorhinolaryngologic DiseasesHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

PregnenedionesPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Zhang Luo

    Beijing Institute of Otolaryngology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
President,Beijing TongRen Hospital

Study Record Dates

First Submitted

September 1, 2019

First Posted

September 4, 2019

Study Start

June 1, 2016

Primary Completion

September 30, 2016

Study Completion

September 30, 2016

Last Updated

September 4, 2019

Record last verified: 2019-09

Locations

CN(1)