Airway Inflammation in Children With Allergic Rhinitis and Intervention

Inflammation Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02352168
• Other study ID #: GuangzhouIRD-LSUN
• Status: Completed
• Phase: N/A
• Start date: September 2014
• Est. completion date: October 2015

Study information

• Verified date: March 2021
• Source: Guangzhou Institute of Respiratory Disease
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 14 Years

Eligibility

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

Related Conditions & MeSH terms

• Allergic Rhinitis
• Hypersensitivity
• Inflammation
• Respiratory Tract Diseases
• Rhinitis
• Rhinitis, Allergic

Intervention

Drug:
• Budesonide nasal spray
64mcg/1putt, 1 putt/nostril,b.i.d
• Placebo
1 putt/nostril,b.i.d

Locations

Country	Name	City	State
China	Guangzhou institute of respiratory disease	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Guangzhou Institute of Respiratory Disease

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	Change of upper airway inflammation biomarker such as eosinophils in nasal lavage		0 w,4 w,8 w and 12 w after treatment
Secondary	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
Secondary	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
Secondary	The change in visual analogue scale score for symptoms of rhinitis		0 w,4 w,8 w and 12 w after treatment
Secondary	Juniper mini RQLQ		0 w,4 w,8 w and 12 w after treatment
Secondary	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
Secondary	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
Secondary	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