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Airway Inflammation in Children With Allergic Rhinitis and Intervention

Primary Purpose

Allergic Rhinitis, Inflammation, Respiratory Tract Diseases

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Budesonide nasal spray
Placebo
Sponsored by
Guangzhou Institute of Respiratory Disease
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Allergic Rhinitis focused on measuring allergic rhinitis;airway inflammation;hyperreactivity

Eligibility Criteria

6 Years - 14 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Sites / Locations

  • Guangzhou institute of respiratory disease

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Budesonide nasal spray

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

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
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

Secondary Outcome Measures

Changes of lower airway resistance (Z5,R5,X5,R5-20,R20 and Fres) using impulse oscillation
Change of upper airway inflammation biomarker such as eosinophils in nasal lavage
Change of cumulative dosage of methacholine causing a 20% fall in forced expiratory volume in 1 second (PD20FEV1-MCH)
To measure the differences in nasal symptoms score (TSS) about groups after 12 weeks of therapy
The parameters considered in the TSS were: nasal obstruction, sneezing, nasal discharge ,itching. These symptoms were scored: 0 = symptom absent, 1 = mild (symptoms present but not annoying), 2 = moderate (frequent and offensive symptoms but do not interfere with sleep or normal activities) 3 = severe (symptoms that interfere with sleep or normal activities).
The change in visual analogue scale score for symptoms of rhinitis
Juniper mini RQLQ
Change in levels of eosinophil(ECP),eosinophil peroxidase(EPO), myeloperoxidase (MPO)and eosinophil-derived neurotoxin (EDN) in induced sputum and serum about groups after twelve weeks of therapy
Change in forced vital capacity (FVC) , in forced expiratory volume in 1 second (FEV1),in forced expired flow at 25% of FVC(FEF25) and in forced expired flow at 75% of FVC (FEF75) about groups after twelve weeks of therapy.
Evaluation of the possible association between upper airway inflammation (eosinophil count in nasal lavage) and bronchial (PD20FEV1-MCH,FeNO and eosinophil count in induced sputum).

Full Information

First Posted
January 21, 2015
Last Updated
March 6, 2021
Sponsor
Guangzhou Institute of Respiratory Disease
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1. Study Identification

Unique Protocol Identification Number
NCT02352168
Brief Title
Airway Inflammation in Children With Allergic Rhinitis and Intervention
Official Title
To Evaluate Airway Inflammation in Children With Allergic Rhinitis and To Examine the Effects of Nasal Corticosteroids Therapy on Lower Airway Inflammation of Rhinitis.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
September 2014 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
October 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Guangzhou Institute of Respiratory Disease

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Type of study : This is a prospective randomized,double-blind, placebo-controlled study , to clarity whether treating upper airway with intranasal corticosteroids in children with allergic rhinitis may bring favors in reducing elevated lower airway inflammation,improving airway reactivity and airway resistance. Methods : The children with allergic rhinitis accompanied lower airway inflammation such as elevated percentage of eosinophil in induced sputums and/or higher level of fractional exhaled nitric oxide(FeNO) are recruited.By using a random digit table, eligible subjects were randomized into one of two groups,to receive budesonide nasal spray (BUD group) or nasal placebo(placebo group), 1 spray/nostril, 2 times/day, for three consecutive months observation. The following measurements were performed: skin prick test (SPT), peripheral blood cells five-classification test, serum total immunoglobulin E (IgE) and specific IgE of common inhalant allergens testing, nasal lavage and inflammatory cells classification ,pulmonary function test, bronchial provocation test,airway resistance measured by impulse oscillation technique. Meanwhile,history of all subjects were collected, visual analogue scale,rhinitis symptoms scores and rhinoconjunctivitis quality of life questionnaire (RQLQ) scores were evaluated. Symptom scores and laboratory examinations are performed at baseline,4 w,8w and 12 w after treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allergic Rhinitis, Inflammation, Respiratory Tract Diseases, Hypersensitivity
Keywords
allergic rhinitis;airway inflammation;hyperreactivity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
68 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Budesonide nasal spray
Arm Type
Active Comparator
Arm Description
Budesonide nasal spray ,64mcg/putt,1 spray/nostril, 2 times/day,for 12 consecutive weeks.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo:nasal placebo spray,1spray/nostril, 2 times/day,for 12 consecutive weeks.
Intervention Type
Drug
Intervention Name(s)
Budesonide nasal spray
Other Intervention Name(s)
intanasal corticosteroids
Intervention Description
64mcg/1putt, 1 putt/nostril,b.i.d
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Placebo nasal spray
Intervention Description
1 putt/nostril,b.i.d
Primary Outcome Measure Information:
Title
Change from baseline fractional exhaled nitric oxide (FeNO) at 3 months
Description
Fractional exhaled nitric oxide (FeNO) measured at 0 w,4 w,8 w and 12 w after treatment
Time Frame
3 months after treatment
Title
Change from baseline eosinophils in sputum at 3 months
Description
Eosinophils in sputum at measured at 0 w,4 w,8 w and 12 w after treatment
Time Frame
3 months after treatment
Secondary Outcome Measure Information:
Title
Changes of lower airway resistance (Z5,R5,X5,R5-20,R20 and Fres) using impulse oscillation
Time Frame
0 w,4 w,8 w and 12 w after treatment
Title
Change of upper airway inflammation biomarker such as eosinophils in nasal lavage
Time Frame
0 w,4 w,8 w and 12 w after treatment
Title
Change of cumulative dosage of methacholine causing a 20% fall in forced expiratory volume in 1 second (PD20FEV1-MCH)
Time Frame
0 w,4 w,8 w and 12 w after treatment
Title
To measure the differences in nasal symptoms score (TSS) about groups after 12 weeks of therapy
Description
The parameters considered in the TSS were: nasal obstruction, sneezing, nasal discharge ,itching. These symptoms were scored: 0 = symptom absent, 1 = mild (symptoms present but not annoying), 2 = moderate (frequent and offensive symptoms but do not interfere with sleep or normal activities) 3 = severe (symptoms that interfere with sleep or normal activities).
Time Frame
0 w,4 w,8 w and 12 w after treatment
Title
The change in visual analogue scale score for symptoms of rhinitis
Time Frame
0 w,4 w,8 w and 12 w after treatment
Title
Juniper mini RQLQ
Time Frame
0 w,4 w,8 w and 12 w after treatment
Title
Change in levels of eosinophil(ECP),eosinophil peroxidase(EPO), myeloperoxidase (MPO)and eosinophil-derived neurotoxin (EDN) in induced sputum and serum about groups after twelve weeks of therapy
Time Frame
At baseline and 12 w after treatment
Title
Change in forced vital capacity (FVC) , in forced expiratory volume in 1 second (FEV1),in forced expired flow at 25% of FVC(FEF25) and in forced expired flow at 75% of FVC (FEF75) about groups after twelve weeks of therapy.
Time Frame
0 w,4 w,8 w and 12 w after treatment
Title
Evaluation of the possible association between upper airway inflammation (eosinophil count in nasal lavage) and bronchial (PD20FEV1-MCH,FeNO and eosinophil count in induced sputum).
Time Frame
At the inclusion visit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: clinical diagnosis of allergic rhinitis without asthma sensitized to more than 1 common aeroaller¬gens FeNO >20ppb and/or induced sputum Eosinophil>2.5% Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nanshanzhong Zhong, master
Organizational Affiliation
Guangzhou Institute of Respiratory Disease
Official's Role
Principal Investigator
Facility Information:
Facility Name
Guangzhou institute of respiratory disease
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510120
Country
China

12. IPD Sharing Statement

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Airway Inflammation in Children With Allergic Rhinitis and Intervention

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