NCT02352168

Brief Summary

The purpose of this study is to determine whether treating upper airway with intranasal corticosteroids in children with allergic rhinitis and no asthma may bring favors in reducing lower airway inflammation and improving small airway function.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
68

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2014

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

September 1, 2014

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 21, 2015

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 2, 2015

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

March 9, 2021

Status Verified

March 1, 2021

Enrollment Period

1.1 years

First QC Date

January 21, 2015

Last Update Submit

March 6, 2021

Conditions

Allergic RhinitisInflammationRespiratory Tract DiseasesHypersensitivity

Keywords

allergic rhinitis；airway inflammation；hyperreactivity

Outcome Measures

Primary Outcomes (2)

  • Change from baseline fractional exhaled nitric oxide (FeNO) at 3 months

    Fractional exhaled nitric oxide (FeNO) measured at 0 w,4 w,8 w and 12 w after treatment

    3 months after treatment

  • Change from baseline eosinophils in sputum at 3 months

    Eosinophils in sputum at measured at 0 w,4 w,8 w and 12 w after treatment

    3 months after treatment

Secondary Outcomes (9)

  • Changes of lower airway resistance (Z5,R5,X5,R5-20,R20 and Fres) using impulse oscillation

    0 w,4 w,8 w and 12 w after treatment

  • Change of upper airway inflammation biomarker such as eosinophils in nasal lavage

    0 w,4 w,8 w and 12 w after treatment

  • Change of cumulative dosage of methacholine causing a 20% fall in forced expiratory volume in 1 second (PD20FEV1-MCH)

    0 w,4 w,8 w and 12 w after treatment

  • To measure the differences in nasal symptoms score (TSS) about groups after 12 weeks of therapy

    0 w,4 w,8 w and 12 w after treatment

  • The change in visual analogue scale score for symptoms of rhinitis

    0 w,4 w,8 w and 12 w after treatment

  • +4 more secondary outcomes

Study Arms (2)

Budesonide nasal spray

ACTIVE COMPARATOR

Budesonide nasal spray ,64mcg/putt,1 spray/nostril, 2 times/day,for 12 consecutive weeks.

Drug: Budesonide nasal spray

Placebo

PLACEBO COMPARATOR

Placebo:nasal placebo spray,1spray/nostril, 2 times/day,for 12 consecutive weeks.

Drug: Placebo

Interventions

Budesonide nasal sprayDRUG

64mcg/1putt, 1 putt/nostril,b.i.d

Also known as: intanasal corticosteroids
Budesonide nasal spray
PlaceboDRUG

1 putt/nostril,b.i.d

Also known as: Placebo nasal spray
Placebo

Eligibility Criteria

Age6 Years - 14 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • clinical diagnosis of allergic rhinitis without asthma
  • sensitized to more than 1 common aeroaller¬gens
  • FeNO \>20ppb and/or induced sputum Eosinophil\>2.5%

You may not qualify if:

  • Respiratory infection 2 weeks prior to initial visit
  • children with nasal polyposis
  • History of immunotherapy
  • unable to complete the test or had limited understanding
  • Use of systemic corticosteroids 4 weeks prior to initial visit
  • nasal and inhaled corticosteroids 2 weeks prior to initial visit
  • leukotriene receptor antagonists 2 weeks prior to initial visit
  • Use of antihistamines 7 days prior to initial visit

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Guangzhou institute of respiratory disease

Guangzhou, Guangdong, 510120, China

Location

MeSH Terms

Conditions

Rhinitis, AllergicInflammationRespiratory Tract DiseasesHypersensitivity

Condition Hierarchy (Ancestors)

RhinitisNose DiseasesRespiratory HypersensitivityOtorhinolaryngologic DiseasesHypersensitivity, ImmediateImmune System DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Nanshanzhong Zhong, master

    Guangzhou Institute of Respiratory Disease

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associate professor

Study Record Dates

First Submitted

January 21, 2015

First Posted

February 2, 2015

Study Start

September 1, 2014

Primary Completion

October 1, 2015

Study Completion

October 1, 2015

Last Updated

March 9, 2021

Record last verified: 2021-03

Locations

CN(1)