Airway Inflammation in Children With Allergic Rhinitis and Intervention

To Evaluate Airway Inflammation in Children With Allergic Rhinitis and To Examine the Effects of Nasal Corticosteroids Therapy on Lower Airway Inflammation of Rhinitis.

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.

Study Overview

• Status: Completed
• Conditions: Respiratory Tract Diseases; Inflammation; Hypersensitivity; Allergic Rhinitis
• Intervention / Treatment: Drug: Budesonide nasal spray; Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 68
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510120
      • Guangzhou Institute of Respiratory Disease

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 14 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Budesonide nasal spray; Budesonide nasal spray ,64mcg/putt,1 spray/nostril, 2 times/day,for 12 consecutive weeks.	Drug: Budesonide nasal spray; 64mcg/1putt, 1 putt/nostril,b.i.d; Other Names: intanasal corticosteroids
Placebo Comparator: Placebo; Placebo:nasal placebo spray,1spray/nostril, 2 times/day,for 12 consecutive weeks.	Drug: Placebo; 1 putt/nostril,b.i.d; Other Names: Placebo nasal spray

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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).	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
Juniper mini RQLQ		0 w,4 w,8 w and 12 w after treatment
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		At baseline and 12 w after treatment
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.		0 w,4 w,8 w and 12 w after treatment
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).		At the inclusion visit

Collaborators and Investigators

• Sponsor: Guangzhou Institute of Respiratory Disease
• Investigators: Principal Investigator: Nanshanzhong Zhong, master, Guangzhou Institute of Respiratory Disease

Study record dates

Study Major Dates

• Study Start: September 1, 2014
• Primary Completion (Actual): October 1, 2015
• Study Completion (Actual): October 1, 2015

Study Registration Dates

• First Submitted: January 21, 2015
• First Submitted That Met QC Criteria: January 30, 2015
• First Posted (Estimate): February 2, 2015

Study Record Updates

• Last Update Posted (Actual): March 9, 2021
• Last Update Submitted That Met QC Criteria: March 6, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: allergic rhinitis；airway inflammation；hyperreactivity
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Respiratory Tract Infections; Immune System Diseases; Hypersensitivity, Immediate; Otorhinolaryngologic Diseases; Respiratory Hypersensitivity; Nose Diseases; Hypersensitivity; Inflammation; Rhinitis; Rhinitis, Allergic; Respiratory Tract Diseases; Physiological Effects of Drugs; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Budesonide
• Other Study ID Numbers: GuangzhouIRD-LSUN