AsthmaPhase 4NCT02574975
Assessment of Airway Responsiveness and Treatment Efficacy in Asthmatics
A Phase 4 study testing methacholine, adenosine monophosphate and leukotriene D4 in people with Asthma, run by Zhujiang Hospital at 1 site in China.
Trial summary
Bronchial asthma is a common chronic respiratory disease. Patients usually manifest variable symptoms (such as short of breath, chest tightness, cough, etc.) and variable airflow limitation and often associated with airway hyper-responsiveness and airway inflammation. Read more about this study
- Who is it for?
- Ages 14 to 65 years
- Conditions the study is for
- Asthma
- What is being tested?
- methacholine, adenosine monophosphate and leukotriene D4
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- Apr 2015to May 2016
- Phase
- Phase 4
- 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 14 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Clinically diagnosed Asthmatic patients aged from14 to 65 years；
- Had a had a normal chest radiographic result；
- Had a baseline spirometry with the forced expiratory volume in one second (FEV1) of not less than 60% predicted；
- Without acute upper respiratory tract infection for the past 2 weeks
Who cannot join
- Smokers；
- Had a poor cooperation to the test or limited understandings;
- Had a past confirmed history of respiratory disease other than bronchial asthma (COPD, bronchiectasis, pulmonary thromboembolism, etc.) or other severe systemic disease（myocardial infarction, malignant tumor, etc.）;
- Pregnancy or breast-feeding women;
- Taken related drugs before measurements（Leukotriene receptor antagonists (LTRA) for 5 days，oral glucocorticosteroid or anti-histamine for 3 days，oral xanthenes or long-acting bronchodilators for 2 days，inhaled corticosteroid or long-acting bronchodilator for a day , short-acting bronchodilator for 4 hours ）
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhujiang Hospital
Guangzhou, Guangdong, 510280
Shuhan Wu, Master, 13268268627, 664397041@qq.com
About this study
Official title: Comparison of Different Methodologies Assessing Airway Responsiveness and Investigation of Treatment Efficacy of Budesonide /Formoterol in Asthmatics
Bronchial asthma is a common chronic respiratory disease. Patients usually manifest variable symptoms (such as short of breath, chest tightness, cough, etc.) and variable airflow limitation and often associated with airway hyper-responsiveness and airway inflammation. About 1-18% of the global population suffered from the disease, causing huge economic burden for patients and countries. Airway reactivity measurement is an important way of diagnosis of asthma. Methacholine (Mch) bronchial provocation test(BPT) is the "gold standard" for the determination of airway reactivity, and other measuring methods(like adenosine monophosphate(AMP)-BPT, leukotriene D4(LTD4)-BPT, Astograph-BPT, etc.) were also brought into hot research fields. The investigators' purposes were to compare different kinds of methodologies(Mch,AMP,LTD4-BPT, Astograph-BPT) assessing airway responsiveness and to investigate treatment efficacy of budesonide /formoterol in asthmatics.
Read the detailed description
This study composed of two parts, that were the diagnosing part and the treatment part.
- Conditions
- Asthma
- Being tested
- methacholine, adenosine monophosphate, leukotriene D4, Astograph Jupiter-21 airway reaction testing apparatus, budesonide /formoterol
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
methacholineDrug
Methacholine,inhaled cumulative dosage 2.5mg
adenosine monophosphateDrug
Adenosine monophosphate ,inhaled cumulative dosage 40mg
leukotriene D4Drug
Leukotriene D4,inhaled cumulative dosage 2.4 μg
Astograph Jupiter-21 airway reaction testing apparatusDevice
Methacholine bronchial provocation test was performed by using Astograph Jupiter-21 airway reaction testing apparatus
budesonide /formoterolDrug
Also called Symbicort
budesonide 160μg and formoterol 4.5ug,1 inhalation ,twice daily ,for three months in all participants (80 Anticipated)
| Study group | Role | What they receive |
|---|---|---|
| Methacholine diagnosing group | Active comparator | Methacholine bronchial provocation test was performed by using Jaeger spirometry with Aerosol Provocation System Receives: Drug: methacholine |
| Adenosine monophosphate diagnosing group | Experimental | Adenosine monophosphate bronchial provocation test was performed by using Jaeger spirometry with Aerosol Provocation System Receives: Drug: adenosine monophosphate |
| Leukotriene D4 diagnosing group | Experimental | Leukotriene D4 bronchial provocation test was performed by using Jaeger spirometry with Aerosol Provocation System Receives: Drug: leukotriene D4 |
| Astograh diagnosing group | Experimental | Methacholine bronchial provocation test was performed by using Astograph Jupiter-21 airway reaction testing apparatus Receives: Device: Astograph Jupiter-21 airway reaction testing apparatus |
| budesonide /formoterol treatment group | Experimental | budesonide 160μg and formoterol 4.5ug,1 inhalation ,twice daily ,for three month Receives: Drug: budesonide /formoterol |
What is being measured
The primary outcome is the main question the study is designed to answer.
positive rate of BPT in each group
comparing positive rates of BPT in experimental groups and control group
Measured: 3months
Secondary outcomes (3)
Forced expiratory volume at one second（FEV1）
change of FEV1 measured by pulmonary function test（PFT）at one month interval for 3 consecutive months
Measured: 3months
Fractional exhaled nitric oxide(FeNO)
change of FeNO at one month interval for 3 consecutive months
Measured: 3months
Provocative dosage causing a 20% fall in FEV1(PD20-FEV1)
change of PD20-FEV1 at one month interval for 3 consecutive months in each group
Measured: 3months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2015 (estimated)
- Study startApr 2015
- Primary completionMay 2016 (estimated)
- Study completionMay 2016 (estimated)
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.
- More trials run by Zhujiang HospitalThe sponsor's other registered studies.
- 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 4
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhujiang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Huizhen Fan, Doctor, Study chair, Zhujiang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02574975
- Sponsor's protocol ID
- ZhujiangH
- Status last verified
- Oct 2015
- First submitted
- 8 Oct 2015
- Last updated
- 16 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Different Methodologies Assessing Airway Responsiveness and Investigation of Treatment Efficacy of Budesonide /Formoterol in Asthmatics
- ClinicalTrials.gov ID
- NCT02574975
- Acronym / sponsor ID
- ZhujiangH
- Conditions
- Asthma
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Zhujiang HospitalUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- May 2016 (estimated)
- Study completion
- May 2016 (estimated)
- First posted
- 14 Oct 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.
Bronchial asthma is a common chronic respiratory disease. Patients usually manifest variable symptoms (such as short of breath, chest tightness, cough, etc.) and variable airflow limitation and often associated with airway hyper-responsiveness and airway inflammation. About 1-18% of the global population suffered from the disease, causing huge economic burden for patients and countries. Airway reactivity measurement is an important way of diagnosis of asthma. Methacholine (Mch) bronchial provocation test(BPT) is the "gold standard" for the determination of airway reactivity, and other measuring methods(like adenosine monophosphate(AMP)-BPT, leukotriene D4(LTD4)-BPT, Astograph-BPT, etc.) were also brought into hot research fields. The investigators' purposes were to compare different kinds of methodologies(Mch,AMP,LTD4-BPT, Astograph-BPT) assessing airway responsiveness and to investigate treatment efficacy of budesonide /formoterol in asthmatics.
Detailed description
This study composed of two parts, that were the diagnosing part and the treatment part.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Methacholine diagnosing group | Active comparator | Drug: methacholineMethacholine bronchial provocation test was performed by using Jaeger spirometry with Aerosol Provocation System |
| Adenosine monophosphate diagnosing group | Experimental | Drug: adenosine monophosphateAdenosine monophosphate bronchial provocation test was performed by using Jaeger spirometry with Aerosol Provocation System |
| Leukotriene D4 diagnosing group | Experimental | Drug: leukotriene D4Leukotriene D4 bronchial provocation test was performed by using Jaeger spirometry with Aerosol Provocation System |
| Astograh diagnosing group | Experimental | Device: Astograph Jupiter-21 airway reaction testing apparatusMethacholine bronchial provocation test was performed by using Astograph Jupiter-21 airway reaction testing apparatus |
| budesonide /formoterol treatment group | Experimental | Drug: budesonide /formoterolbudesonide 160μg and formoterol 4.5ug,1 inhalation ,twice daily ,for three month |
Who may qualify
- Ages
- 14 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Clinically diagnosed Asthmatic patients aged from14 to 65 years；
- Had a had a normal chest radiographic result；
- Had a baseline spirometry with the forced expiratory volume in one second (FEV1) of not less than 60% predicted；
- Without acute upper respiratory tract infection for the past 2 weeks
Key exclusion criteria (5 listed)
- Smokers；
- Had a poor cooperation to the test or limited understandings;
- Had a past confirmed history of respiratory disease other than bronchial asthma (COPD, bronchiectasis, pulmonary thromboembolism, etc.) or other severe systemic disease（myocardial infarction, malignant tumor, etc.）;
- Pregnancy or breast-feeding women;
- Taken related drugs before measurements（Leukotriene receptor antagonists (LTRA) for 5 days，oral glucocorticosteroid or anti-histamine for 3 days，oral xanthenes or long-acting bronchodilators for 2 days，inhaled corticosteroid or long-acting bronchodilator for a day , short-acting bronchodilator for 4 hours ）
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 |
|---|---|---|
| methacholineMethacholine,inhaled cumulative dosage 2.5mg | Drug | Methacholine diagnosing group |
| adenosine monophosphateAdenosine monophosphate ,inhaled cumulative dosage 40mg | Drug | Adenosine monophosphate diagnosing group |
| leukotriene D4Leukotriene D4,inhaled cumulative dosage 2.4 μg | Drug | Leukotriene D4 diagnosing group |
| Astograph Jupiter-21 airway reaction testing apparatusMethacholine bronchial provocation test was performed by using Astograph Jupiter-21 airway reaction testing apparatus | Device | Astograh diagnosing group |
| budesonide /formoterolAlso: Symbicortbudesonide 160μg and formoterol 4.5ug,1 inhalation ,twice daily ,for three months in all participants (80 Anticipated) | Drug | budesonide /formoterol treatment group |
Primary outcome
positive rate of BPT in each group
Time frame: 3months
comparing positive rates of BPT in experimental groups and control group
3 secondary outcomes
Forced expiratory volume at one second（FEV1）
Time frame: 3months
Fractional exhaled nitric oxide(FeNO)
Time frame: 3months
Provocative dosage causing a 20% fall in FEV1(PD20-FEV1)
Time frame: 3months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2015.
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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.
Huizhen Fan, Doctor study chair
Zhujiang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing methacholine, adenosine monophosphate and leukotriene D4 in people with Asthma, run by Zhujiang Hospital 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 4 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 16 Oct 2015. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Shuhan Wu, Master (13268268627, 664397041@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
positive rate of BPT in each group (time frame: 3months). 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 Oct 2015.