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.
Verified date | March 2021 |
Source | Guangzhou Institute of Respiratory Disease |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
China | Guangzhou institute of respiratory disease | Guangzhou | Guangdong |
Lead Sponsor | Collaborator |
---|---|
Guangzhou Institute of Respiratory Disease |
China,
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 |
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