RhinitisNCT02360072
Airway Inflammation and Bronchial Hyperresponsiveness in Rhinitic Children With or Without Asthma
An observational study of Rhinitis and Asthma, run by Guangzhou Institute of Respiratory Disease at 1 site in China.
Trial summary
This is a prospective observational study , to clarity the characteristics of airway inflammation, airway reactivity and airway resistance in rhinitic children with or without asthma and to explore the possible predictors in the progression of allergic rhinitis to asthma. Read more about this study
- Who is it for?
- Ages 6 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Rhinitis, Asthma, Inflammation
- How many people
- 280 participants
- Where
- 1 siteChina
- Study dates
- Sep 2014to Sep 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Children 6-15 years old with allergic rhinitis and/or asthma diagnosed by specialist physician were enrolled in the department of paediatrics,respiratory and otorhinolaryngology in Guangzhou Institue of Respiratory Diseas .In addition, healthy students in a school were enrolled as normal control group.
Who may be able to join
- Clinical diagnosis of allergic rhinitis and/or asthma
- Sensitized to more than 1 common aeroallergens
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
Guangzhou institute of respiratory disease
Guangzhou, Guangdong, 510120
About this study
Official title: To Delineate the Characteristics of Airway Inflammation and Bronchial Hyperresponsiveness in Rhinitic Children With or Without Asthma and Sought to Explore a Possible Predictor in the Progression of Allergic Rhinitis to Asthma
This is a prospective observational study , to clarity the characteristics of airway inflammation, airway reactivity and airway resistance in rhinitic children with or without asthma and to explore the possible predictors in the progression of allergic rhinitis to asthma.
Read the detailed description
Children 6-15 years old with allergic rhinitis and/or asthma diagnosed by specialist physician are enrolled in the department of respiratory and otorhinolaryngology and pediatrics in Guangzhou Institute of Respiratory Disease. According to presence of typical symptoms and signs, patients are divided into allergic rhinitis without asthma (AR group) , allergic rhinitis concomitant asthma (AS+AR group), asthma without rhinitis (AS group). In addition, healthy students in a school are enrolled as normal control group. History of all subjects are collected, the following measurements are 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 induced sputum cells classification ，pulmonary function test, bronchial provocation test using methacholine，airway resistance measured by impulse oscillation technique, the levels of eosinophil（ECP），eosinophil peroxidase（EPO）.Meanwhile myeloperoxidase （MPO）and eosinophil-derived neurotoxin (EDN) are measured in induced sputum ,in nasal lavage and in serum.
- Conditions
- Rhinitis, Asthma, Inflammation, Hypersensitivity
- Keywords
- child, allergic rhinitis, asthma, nitric oxide, bronchial hyper-responsiveness
- Medical subject headings
- Rhinitis, Asthma, Inflammation, Hypersensitivity, Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| AR group | Allergic rhinitis without any typical asthma symptoms | |
| Asthma | Accompanied by typical asthma symptoms and Δ FEV1≥12% in response to a short-acting bronchodilator or bronchial hyperreactivity(BHR) in the methacholine provocation test (PC20≤2.504mg) | |
| AR+Asthma | Diagnosed allergic rhinitis concomitant asthma symptoms | |
| Control group | non-atopic subjects with neither a history of rhinitis nor asthma |
What is being measured
The primary outcome is the main question the study is designed to answer.
To explore if an elevated level of fractional exhaled nitric oxide(FeNO) is a possible predictor of bronchial hyperresponsiveness in AR.
Measured: 1 year
Secondary outcomes (6)
To explore if an elevated eosinophils in induced sputum is a possible predictor of bronchial hyperresponsiveness in AR.
Measured: 1 year
To explore if an elevated eosinophils in nasal nasal lavage fluid is a possible predictor of bronchial hyperresponsiveness in AR.
Measured: 1 year
To compare lower airway resistance (Z5,R5,X5,R5-20,R20 and Fres) using impulse oscillation among the groups [Allergic rhinitis(AR) group, Asthma group, AR+Asthma and control group].
Measured: 1 year
To compare cumulative dosage of methacholine causing a 20% fall in forced expiratory volume in 1 second (PC20FEV1-MCH) among the groups.
Measured: 1 year
To compare forced vital capacity (FVC) , forced expiratory volume in 1 second (FEV1)， forced expired flow at 25% of FVC(FEF25) and forced expired flow at 75% of FVC (FEF75) among groups.
Measured: 1 year
To compare levels of eosinophil（ECP），eosinophil peroxidase（EPO）, myeloperoxidase （MPO）and eosinophil-derived neurotoxin (EDN) in induced sputum and nasal lavage fluid among the groups.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2015 (estimated)
- Study startSep 2014
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RhinitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 280 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guangzhou Institute of Respiratory Disease
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, LI-HONG SUN, Guangzhou Institute of Respiratory Disease
- Investigators
- Nanshan Zhong, master, Study director, Guangzhou Institute of Respiratory Disease
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02360072
- Sponsor's protocol ID
- GuangzhouIRD-LSUN1
- Status last verified
- Mar 2021
- First submitted
- 5 Feb 2015
- Last updated
- 9 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Delineate the Characteristics of Airway Inflammation and Bronchial Hyperresponsiveness in Rhinitic Children With or Without Asthma and Sought to Explore a Possible Predictor in the Progression of Allergic Rhinitis to Asthma
- ClinicalTrials.gov ID
- NCT02360072
- Acronym / sponsor ID
- GuangzhouIRD-LSUN1
- Conditions
- Rhinitis, Asthma, Inflammation, Hypersensitivity
- Keywords
- child, allergic rhinitis, asthma, nitric oxide, bronchial hyper-responsiveness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 280 participants (actual)
- Lead sponsor
- Guangzhou Institute of Respiratory DiseaseUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 10 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective observational study , to clarity the characteristics of airway inflammation, airway reactivity and airway resistance in rhinitic children with or without asthma and to explore the possible predictors in the progression of allergic rhinitis to asthma.
Detailed description
Children 6-15 years old with allergic rhinitis and/or asthma diagnosed by specialist physician are enrolled in the department of respiratory and otorhinolaryngology and pediatrics in Guangzhou Institute of Respiratory Disease. According to presence of typical symptoms and signs, patients are divided into allergic rhinitis without asthma (AR group) , allergic rhinitis concomitant asthma (AS+AR group), asthma without rhinitis (AS group). In addition, healthy students in a school are enrolled as normal control group. History of all subjects are collected, the following measurements are 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 induced sputum cells classification ，pulmonary function test, bronchial provocation test using methacholine，airway resistance measured by impulse oscillation technique, the levels of eosinophil（ECP），eosinophil peroxidase（EPO）.Meanwhile myeloperoxidase （MPO）and eosinophil-derived neurotoxin (EDN) are measured in induced sputum ,in nasal lavage and in serum.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| AR group | – | –Allergic rhinitis without any typical asthma symptoms |
| Asthma | – | –Accompanied by typical asthma symptoms and Δ FEV1≥12% in response to a short-acting bronchodilator or bronchial hyperreactivity(BHR) in the methacholine provocation test (PC20≤2.504mg) |
| AR+Asthma | – | –Diagnosed allergic rhinitis concomitant asthma symptoms |
| Control group | – | –non-atopic subjects with neither a history of rhinitis nor asthma |
Who may qualify
- Ages
- 6 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Children 6-15 years old with allergic rhinitis and/or asthma diagnosed by specialist physician were enrolled in the department of paediatrics,respiratory and otorhinolaryngology in Guangzhou Institue of Respiratory Diseas .In addition, healthy students in a school were enrolled as normal control group.
Key inclusion criteria (2 listed)
- Clinical diagnosis of allergic rhinitis and/or asthma
- Sensitized to more than 1 common aeroallergens
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To explore if an elevated level of fractional exhaled nitric oxide(FeNO) is a possible predictor of bronchial hyperresponsiveness in AR.
Time frame: 1 year
6 secondary outcomes
To explore if an elevated eosinophils in induced sputum is a possible predictor of bronchial hyperresponsiveness in AR.
Time frame: 1 year
To explore if an elevated eosinophils in nasal nasal lavage fluid is a possible predictor of bronchial hyperresponsiveness in AR.
Time frame: 1 year
To compare lower airway resistance (Z5,R5,X5,R5-20,R20 and Fres) using impulse oscillation among the groups [Allergic rhinitis(AR) group, Asthma group, AR+Asthma and control group].
Time frame: 1 year
To compare cumulative dosage of methacholine causing a 20% fall in forced expiratory volume in 1 second (PC20FEV1-MCH) among the groups.
Time frame: 1 year
To compare forced vital capacity (FVC) , forced expiratory volume in 1 second (FEV1)， forced expired flow at 25% of FVC(FEF25) and forced expired flow at 75% of FVC (FEF75) among groups.
Time frame: 1 year
To compare levels of eosinophil（ECP），eosinophil peroxidase（EPO）, myeloperoxidase （MPO）and eosinophil-derived neurotoxin (EDN) in induced sputum and nasal lavage fluid among the groups.
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nanshan Zhong, master study director
Guangzhou Institute of Respiratory Disease
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rhinitis and Asthma, run by Guangzhou Institute of Respiratory Disease at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To explore if an elevated level of fractional exhaled nitric oxide(FeNO) is a possible predictor of bronchial hyperresponsiveness in AR. (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2021.