AsthmaNCT03467776
Bronchial Dilation Test in Wheezy Infants
An observational study of Asthma, run by Guangzhou Institute of Respiratory Disease at 1 site in China.
Trial summary
The purpose of the study is to establish the methodology of bronchial dilation test by salbutamol MDI with Spacer in wheezy infants with asthma and to evaluate the effects of atopy on the exacerbation of wheeze in wheezy infants. Read more about this study
- Who is it for?
- Ages 5 to 36 monthsHealthy volunteers can take part
- Conditions the study is for
- Asthma
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- Jul 2018to Dec 2019
- 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 5 to 36 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: all the subjects will be recurited from the First Affiliated Hospital of Guangzhou Medical University
Who may be able to join
- normal term infants.Recurrent wheezing with or without atopy,none of the subjects had a history of respiratory illness, congenital heart disease,dysphagia,oxygen saturation≤90% on room air,an active seizure disorder,or upper airway obstruction,or requirement for assisted ventilation in the neonatal periods,all infants were asymptomatic for at least 2 weeks preceding the test.
Who cannot join
- subjects had a history of respiratory illness, congenital heart disease,dysphagia,oxygen saturation≤90% on room air,an active seizure disorder,or upper airway obstruction,;all infants were asymptomatic for at least 2 weeks preceding the test.
Trial locations and contacts
1 site in 1 country.
China1 site
State Key Laboratory of Respiratory Disease;China Clinical Research Center of Respiratory Disease;First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510120
About this study
Official title: Brochial Dilation Test by Salbutamol Metered Dose Inhaler(MDI) With Spacer in Wheezy Infants With Asthma Risk Factors
The purpose of the study is to establish the methodology of bronchial dilation test by salbutamol MDI with Spacer in wheezy infants with asthma and to evaluate the effects of atopy on the exacerbation of wheeze in wheezy infants.
Read the detailed description
After screening,each participant undergo baseline pulmonary function test(Jaeger Master Screen Baby Body, Germany)and post-bronchodilator measurements that performed 10min after 200ug of salbutamol administered using a metered-dose inhaler and a spacer.
The participants undergo baseline lung function test and bronchial dilation tests on the second and third visits with one-month interval,and whenever there is an exacerbation.
- Conditions
- Asthma
- Keywords
- infants, asthma, bronchial dilation test, plethysmography
- Medical subject headings
- Asthma
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 |
|---|---|---|
| healthy | healthy control, 5 months to 3 years | |
| wheezing with atopy | suspected asthma with wheezing (>3 episodes per year) and atopy | |
| wheezing without atopy | wheezing without atopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
airway resistance(Raw) performed by body plethysmography before and after bronchial dilation test.
airway resistance(Raw) at rest
Measured: Change from baseline at 20 mins after inhalation of salbutamol
Secondary outcomes (1)
airway resistance(Raw) performed by body plethysmography
airway resistance(Raw) measured within 24 hours whenever there is an exacerbation of wheeze.
Measured: at 24 hours of the exacerbation of wheeze
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2018
- Study startJul 2018 (estimated)
- Primary completionMay 2019 (estimated)
- Study completionDec 2019 (estimated)
Why it stopped: have to adjust recuriting paticipants projects and have to halted the research
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 90 participants (estimated)
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, Guangzhou Institute of Respiratory Disease
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03467776
- Sponsor's protocol ID
- GIRD201535
- Status last verified
- Mar 2018
- First submitted
- 14 Feb 2018
- Last updated
- 16 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brochial Dilation Test by Salbutamol Metered Dose Inhaler(MDI) With Spacer in Wheezy Infants With Asthma Risk Factors
- ClinicalTrials.gov ID
- NCT03467776
- Acronym / sponsor ID
- GIRD201535
- Conditions
- Asthma
- Keywords
- infants, asthma, bronchial dilation test, plethysmography
- Study type
- Observational
- Recruitment status
- SuspendedReason stopped: have to adjust recuriting paticipants projects and have to halted the research
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Guangzhou Institute of Respiratory DiseaseUniversity, hospital or other
- Collaborators
- Firestone Institute for Respiratory Health
- Study start
- Jul 2018 (estimated)
- Primary completion
- May 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 16 Mar 2018 (actual)
- 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 the study is to establish the methodology of bronchial dilation test by salbutamol MDI with Spacer in wheezy infants with asthma and to evaluate the effects of atopy on the exacerbation of wheeze in wheezy infants.
Detailed description
After screening,each participant undergo baseline pulmonary function test(Jaeger Master Screen Baby Body, Germany)and post-bronchodilator measurements that performed 10min after 200ug of salbutamol administered using a metered-dose inhaler and a spacer.
The participants undergo baseline lung function test and bronchial dilation tests on the second and third visits with one-month interval,and whenever there is an exacerbation.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| healthy | – | –healthy control, 5 months to 3 years |
| wheezing with atopy | – | –suspected asthma with wheezing (>3 episodes per year) and atopy |
| wheezing without atopy | – | –wheezing without atopy |
Who may qualify
- Ages
- 5 to 36 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- all the subjects will be recurited from the First Affiliated Hospital of Guangzhou Medical University
Key inclusion criteria (1 listed)
- normal term infants.Recurrent wheezing with or without atopy,none of the subjects had a history of respiratory illness, congenital heart disease,dysphagia,oxygen saturation≤90% on room air,an active seizure disorder,or upper airway obstruction,or requirement for assisted ventilation in the neonatal periods,all infants were asymptomatic for at least 2 weeks preceding the test.
Key exclusion criteria (1 listed)
- subjects had a history of respiratory illness, congenital heart disease,dysphagia,oxygen saturation≤90% on room air,an active seizure disorder,or upper airway obstruction,;all infants were asymptomatic for at least 2 weeks preceding the test.
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
airway resistance(Raw) performed by body plethysmography before and after bronchial dilation test.
Time frame: Change from baseline at 20 mins after inhalation of salbutamol
airway resistance(Raw) at rest
1 secondary outcome
airway resistance(Raw) performed by body plethysmography
Time frame: at 24 hours of the exacerbation of wheeze
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2018.
- Individual participant dataSharing planned: No
Related trials for Asthma
Enrolling by invitationObservational study
Allergy, Asthma, and Atopic Eczema in Finland
Asthma, Asthma in Children
RecruitingPhase 2
Rademikibart IV for Acute Asthma and COPD Exacerbation
Asthma Acute, COPD Exacerbation Acute
Active, not recruiting
Community Health Equity Accelerator (CHEA) Pediatric Asthma Intervention
Asthma in Children
Enrolling by invitationObservational study
Firefighter's Longitudinal Airway and Respiratory Exposome/Multiome Study (FLARES)
Anosmia, Chronic Obstructive Pulmonary Disease
RecruitingObservational study
NHALES (Natural History of Asthma With Longitudinal Environmental Sampling)
Asthma
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
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 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 1 inclusion and 1 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: paused, as of the sponsor's last update on 16 Mar 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?
Results are not available in the source record.
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?
airway resistance(Raw) performed by body plethysmography before and after bronchial dilation test. (time frame: Change from baseline at 20 mins after inhalation of salbutamol). 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 16 Mar 2018.