Airway Inflammation in Children With Allergic Rhinitis and Intervention

Guangzhou Institute of Respiratory Disease

Status: Completed

Conditions: Inflammation; Respiratory Tract Diseases; Allergic Rhinitis; Hypersensitivity

Treatments: Drug: Placebo; Drug: Budesonide nasal spray

Study type: Interventional

Funder types: Other

Identifiers

NCT02352168

GuangzhouIRD-LSUN

Details and patient eligibility

About

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.

Full 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.

Enrollment: 68 patients

Sex: All

Ages: 6 to 14 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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68 participants in 2 patient groups, including a placebo group

Budesonide nasal spray

Active Comparator group

Description:

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

Treatment:

Drug: Budesonide nasal spray

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo