Allergic RhinitisNCT02352168
Airway Inflammation in Children With Allergic Rhinitis and Intervention
A study testing Budesonide nasal spray in people with Allergic Rhinitis and Inflammation, run by Guangzhou Institute of Respiratory Disease at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 6 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Allergic Rhinitis, Inflammation, Respiratory Tract Diseases
- What is being tested?
- Budesonide nasal spray
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 68 participants
- Where
- 1 siteChina
- Study dates
- Sep 2014to Oct 2015
- Phase
- Interventional
- 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 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- clinical diagnosis of allergic rhinitis without asthma
- sensitized to more than 1 common aeroaller¬gens
- FeNO >20ppb and/or induced sputum Eosinophil>2.5%
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
- Use of antihistamines 7 days 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 Evaluate Airway Inflammation in Children With Allergic Rhinitis and To Examine the Effects of Nasal Corticosteroids Therapy on Lower Airway Inflammation of Rhinitis.
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.
Read the detailed 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.
- Being tested
- Budesonide nasal spray, Placebo
- Keywords
- allergic rhinitis；airway inflammation；hyperreactivity
- Medical subject headings
- Rhinitis, Allergic, Inflammation, Respiratory Tract Diseases, Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Budesonide nasal sprayDrug
Also called intanasal corticosteroids
64mcg/1putt, 1 putt/nostril,b.i.d
PlaceboDrug
Also called Placebo nasal spray
1 putt/nostril,b.i.d
| Study group | Role | What they receive |
|---|---|---|
| Budesonide nasal spray | Active comparator | Budesonide nasal spray ,64mcg/putt,1 spray/nostril, 2 times/day,for 12 consecutive weeks. Receives: Drug: Budesonide nasal spray |
| Placebo | Placebo comparator | Placebo:nasal placebo spray,1spray/nostril, 2 times/day,for 12 consecutive weeks. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 months after treatment
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
Measured: 3 months after treatment
Secondary outcomes (9)
Changes of lower airway resistance (Z5,R5,X5,R5-20,R20 and Fres) using impulse oscillation
Measured: 0 w,4 w,8 w and 12 w after treatment
Change of upper airway inflammation biomarker such as eosinophils in nasal lavage
Measured: 0 w,4 w,8 w and 12 w after treatment
Change of cumulative dosage of methacholine causing a 20% fall in forced expiratory volume in 1 second (PD20FEV1-MCH)
Measured: 0 w,4 w,8 w and 12 w after treatment
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).
Measured: 0 w,4 w,8 w and 12 w after treatment
The change in visual analogue scale score for symptoms of rhinitis
Measured: 0 w,4 w,8 w and 12 w after treatment
Juniper mini RQLQ
Measured: 0 w,4 w,8 w and 12 w after treatment
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
Measured: At baseline and 12 w after treatment
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.
Measured: 0 w,4 w,8 w and 12 w after treatment
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).
Measured: At the inclusion visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2015 (estimated)
- Study startSep 2014
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergic 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 68 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
- Nanshanzhong Zhong, master, Principal investigator, Guangzhou Institute of Respiratory Disease
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02352168
- Sponsor's protocol ID
- GuangzhouIRD-LSUN
- Status last verified
- Mar 2021
- First submitted
- 21 Jan 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 Evaluate Airway Inflammation in Children With Allergic Rhinitis and To Examine the Effects of Nasal Corticosteroids Therapy on Lower Airway Inflammation of Rhinitis.
- ClinicalTrials.gov ID
- NCT02352168
- Acronym / sponsor ID
- GuangzhouIRD-LSUN
- Keywords
- allergic rhinitis；airway inflammation；hyperreactivity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Guangzhou Institute of Respiratory DiseaseUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 2 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.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Budesonide nasal spray | Active comparator | Drug: Budesonide nasal sprayBudesonide nasal spray ,64mcg/putt,1 spray/nostril, 2 times/day,for 12 consecutive weeks. |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo:nasal placebo spray,1spray/nostril, 2 times/day,for 12 consecutive weeks. |
Who may qualify
- Ages
- 6 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- clinical diagnosis of allergic rhinitis without asthma
- sensitized to more than 1 common aeroaller¬gens
- FeNO >20ppb and/or induced sputum Eosinophil>2.5%
Key exclusion criteria (8 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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Budesonide nasal sprayAlso: intanasal corticosteroids64mcg/1putt, 1 putt/nostril,b.i.d | Drug | Budesonide nasal spray |
| PlaceboAlso: Placebo nasal spray1 putt/nostril,b.i.d | Drug | Placebo |
Primary outcome
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
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
9 secondary outcomes
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
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
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
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 change in visual analogue scale score for symptoms of rhinitis
Time frame: 0 w,4 w,8 w and 12 w after treatment
Juniper mini RQLQ
Time frame: 0 w,4 w,8 w and 12 w after treatment
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
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
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
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.
Nanshanzhong Zhong, master principal investigator
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?
A study testing Budesonide nasal spray in people with Allergic Rhinitis and Inflammation, 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 3 inclusion and 8 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. Some participants in this study may receive a placebo. 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?
Change from baseline fractional exhaled nitric oxide (FeNO) at 3 months (time frame: 3 months after treatment). The study lists 2 primary outcomes in all. 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.