Allergic AsthmaNCT02504528
Bronchial Allergen Provocation Tests in Asthmatics in Guangzhou
A study testing house dust mites in people with Allergic Asthma, run by Guangzhou Institute of Respiratory Disease at 1 site in China.
Trial summary
The purpose of this study is to establish the methodology of bronchial provocation tests with house dust mites in China, and to evaluate its safety and effects on upper and lower airways inflammation. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Allergic Asthma
- What is being tested?
- house dust mites
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2015to 1 Feb 2018
- 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Clinical diagnosis of asthma;
- Sensitive to house dust mite;
- Stable for more than 4 weeks with FEV1≥70%pred
Who cannot join
- exacerbation within 3 months;
- upper airway infections within 6 weeks;
- concomitant of hypertension or heart diseases;
- pregnancy
Trial locations and contacts
1 site in 1 country.
China1 site
Guangzhou institute of respiratory disease
Guangzhou, Guangdong, 510120
About this study
Official title: Bronchial Provocation Tests With House Dust Mite in Allergic Asthma in Guangzhou
The purpose of this study is to establish the methodology of bronchial provocation tests with house dust mites in China, and to evaluate its safety and effects on upper and lower airways inflammation.
Read the detailed description
After screening,each participant undergo baseline lung function test,airway inflammation evaluation (blood and sputum eosinophils count,interleukin-13 (IL-13),FeNO)and airway responsiveness tests(methacholine bronchial provocation,nasal histamine provocation).
On the second day,the participant undergo bronchial house dust mites challenge tests.
On the third day,the participant undergo the lung function test,airway inflammation evaluation (blood and sputum eosinophils count,IL-13,FeNO)and airway responsiveness tests(methacholine bronchial provocation,nasal histamine provocation).
- Conditions
- Allergic Asthma
- Being tested
- house dust mites
- Keywords
- asthma, allergy, bronchial hyperresponsiveness, provocation
- Medical subject headings
- Asthma, Hypersensitivity, Bronchial Hyperreactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
house dust mitesOther
house dust mites(two-fold increasing concentration of house dust mite (HDM) extract, dilutions prepared starting from 1:8, 1:16, 1:32, 1:64, 1:128, 1: 256, 1:512, 1:1024,……)
| Study group | Role | What they receive |
|---|---|---|
| allergic asthma | Experimental | asthma patients that sensitive to house dust mites. Receives: Other: house dust mites |
| normal controls | Experimental | normal controls with or without sensitive to house dust mites. Receives: Other: house dust mites |
What is being measured
The primary outcome is the main question the study is designed to answer.
percentages of the participants that tested positive to house dust mites bronchial provocation
Measured: 30 minutes after house dust mites bronchial provocation
Secondary outcomes (4)
Changes of the percentages of eosinophils in sputum, nasal lavage and fractional exhaled nitric oxide (FeNO) from baseline
Measured: 30mins, 7 and 24 hours after bronchial challenge
Changes of provocative concentration induced a 20% decrease in forced expiratory volume at one second (FEV1) to methacholine before and after house dust mites bronchial provocation
Measured: 24 hours after house dust mites bronchial challenge
percentages of the participants that tested positive to house dust mites bronchial provocation measured by impulse oscillometry
Measured: 10 minutes after house dust mites bronchial provocation
Changes of provocative concentration induced a 60% increase in nasal airway resistance to histamine before and after house dust mites bronchial provocation
By Comparison with methacholine provocation test
Measured: 24 hours after house dust mites bronchial challenge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2015 (estimated)
- Study start1 Jul 2015
- Primary completion1 Jul 2017
- Study completion1 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergic AsthmaStudies 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guangzhou Institute of Respiratory Disease
- Sponsor type
- University, hospital or other
- Collaborators
- Firestone Institute for Respiratory Health
- Responsible party
- Principal investigator, Jinping Zheng, Guangzhou Institute of Respiratory Disease
- Investigators
- Jinping Zheng, Principal investigator, State Key Laboratory of Respiratory Disease; China Clinical Research Center of Respiratory Disease; First Affiliated Hospital of Guangzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02504528
- Sponsor's protocol ID
- GIRD201534
- Other IDs
- BAPT201534
- Status last verified
- Feb 2018
- First submitted
- 8 Jul 2015
- Last updated
- 19 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bronchial Provocation Tests With House Dust Mite in Allergic Asthma in Guangzhou
- ClinicalTrials.gov ID
- NCT02504528
- Acronym / sponsor ID
- GIRD201534
- Conditions
- Allergic Asthma
- Keywords
- asthma, allergy, bronchial hyperresponsiveness, provocation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Guangzhou Institute of Respiratory DiseaseUniversity, hospital or other
- Collaborators
- Firestone Institute for Respiratory Health
- Study start
- 1 Jul 2015
- Primary completion
- 1 Jul 2017 (actual)
- Study completion
- 1 Feb 2018 (actual)
- First posted
- 22 Jul 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 establish the methodology of bronchial provocation tests with house dust mites in China, and to evaluate its safety and effects on upper and lower airways inflammation.
Detailed description
After screening,each participant undergo baseline lung function test,airway inflammation evaluation (blood and sputum eosinophils count,interleukin-13 (IL-13),FeNO)and airway responsiveness tests(methacholine bronchial provocation,nasal histamine provocation).
On the second day,the participant undergo bronchial house dust mites challenge tests.
On the third day,the participant undergo the lung function test,airway inflammation evaluation (blood and sputum eosinophils count,IL-13,FeNO)and airway responsiveness tests(methacholine bronchial provocation,nasal histamine provocation).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| allergic asthma | Experimental | Other: house dust mitesasthma patients that sensitive to house dust mites. |
| normal controls | Experimental | Other: house dust mitesnormal controls with or without sensitive to house dust mites. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Clinical diagnosis of asthma;
- Sensitive to house dust mite;
- Stable for more than 4 weeks with FEV1≥70%pred
Key exclusion criteria (4 listed)
- exacerbation within 3 months;
- upper airway infections within 6 weeks;
- concomitant of hypertension or heart diseases;
- pregnancy
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 |
|---|---|---|
| house dust miteshouse dust mites(two-fold increasing concentration of house dust mite (HDM) extract, dilutions prepared starting from 1:8, 1:16, 1:32, 1:64, 1:128, 1: 256, 1:512, 1:1024,……) | Other | allergic asthma, normal controls |
Primary outcome
percentages of the participants that tested positive to house dust mites bronchial provocation
Time frame: 30 minutes after house dust mites bronchial provocation
4 secondary outcomes
Changes of the percentages of eosinophils in sputum, nasal lavage and fractional exhaled nitric oxide (FeNO) from baseline
Time frame: 30mins, 7 and 24 hours after bronchial challenge
Changes of provocative concentration induced a 20% decrease in forced expiratory volume at one second (FEV1) to methacholine before and after house dust mites bronchial provocation
Time frame: 24 hours after house dust mites bronchial challenge
percentages of the participants that tested positive to house dust mites bronchial provocation measured by impulse oscillometry
Time frame: 10 minutes after house dust mites bronchial provocation
Changes of provocative concentration induced a 60% increase in nasal airway resistance to histamine before and after house dust mites bronchial provocation
Time frame: 24 hours after house dust mites bronchial challenge
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 19 Feb 2018.
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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.
Jinping Zheng principal investigator
State Key Laboratory of Respiratory Disease; China Clinical Research Center of Respiratory Disease; First Affiliated Hospital of Guangzhou Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing house dust mites in people with Allergic 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 3 inclusion and 4 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 19 Feb 2018. 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?
percentages of the participants that tested positive to house dust mites bronchial provocation (time frame: 30 minutes after house dust mites bronchial provocation). 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 19 Feb 2018.