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Completed

NCT Number: NCT02352168

Airway Inflammation in Children With Allergic Rhinitis and Intervention

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.

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Key information

Age range

6 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Guangzhou institute of respiratory disease

Guangzhou, Guangdong, 510120, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Budesonide nasal spray

Drug

64mcg/1putt, 1 putt/nostril,b.i.d

Other names: intanasal corticosteroids

Placebo

Drug

1 putt/nostril,b.i.d

Other names: Placebo nasal spray

Primary outcomes

  1. Change from baseline fractional exhaled nitric oxide (FeNO) at 3 months

    Time frame: 3 months after treatment

    Fractional exhaled nitric oxide (FeNO) measured at 0 w,4 w,8 w and 12 w after treatment

  2. Change from baseline eosinophils in sputum at 3 months

    Time frame: 3 months after treatment

    Eosinophils in sputum at measured at 0 w,4 w,8 w and 12 w after treatment

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. To measure the differences in nasal symptoms score (TSS) about groups after 12 weeks of therapy

    Time frame: 0 w,4 w,8 w and 12 w after treatment

    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).

  5. The change in visual analogue scale score for symptoms of rhinitis

    Time frame: 0 w,4 w,8 w and 12 w after treatment

  6. Juniper mini RQLQ

    Time frame: 0 w,4 w,8 w and 12 w after treatment

  7. 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

  8. 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

  9. 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

Sponsors and collaborators

Lead sponsor

Guangzhou Institute of Respiratory Disease

Other

Registry information

Official study 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.

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Feb 2, 2015
Registry last updated
Mar 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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