Bronchial AsthmaPhase 4NCT02934945
Treatment Efficacy of Budesonide/Formoterol in Cough Variant Asthma and Typical Asthma Patients
A Phase 4 study testing budesonide 160μg/formoterol 4.5μg in people with Bronchial Asthma, run by Zhujiang Hospital at 1 site in China.
Trial summary
Bronchial asthma is a common respiratory disease characterized by chronic airway inflammation, which have been affecting about 1-18% of the population in the world, causing tremendous economic burden for the patients and countries. Read more about this study
- Who is it for?
- Ages 15 to 75 years
- Conditions the study is for
- Bronchial Asthma
- What is being tested?
- budesonide 160μg/formoterol 4.5μg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- Sep 2015to Mar 2017
- 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 15 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- aged 15-75
- first diagnosed corresponding to the diagnostic standards established by Asthma Committee, Respiratory Society, Chinese Medical Association, or previously diagnosed asthma without regular treatment
- Mch bronchial provocation test is positive
- the chest X-ray is normal.
Who cannot join
- accompanied by other disease of respiratory system
- combined with serious illness of other system, such as myocardial infarction, severe arrhythmia, malignant tumors and so on
- women with pregnancy or lactation.
Trial locations and contacts
1 site in 1 country.
Jielu Liu, M.D contact
China1 site, 1 recruiting
- Recruiting
Zhujiang Hospital of Southern Medical University
Guangzhou, Guangdong, 510282
Shuyu Chen, M.D, 13580421202, 1137968694@qq.com
Jielu Liu, M.D
About this study
Bronchial asthma is a common respiratory disease characterized by chronic airway inflammation, which have been affecting about 1-18% of the population in the world, causing tremendous economic burden for the patients and countries. Generally, asthma is a heterogeneous disease, and it could be classified into many types on the basis of symptoms, that is, typical asthma, cough variant asthma, and chest tightness variant asthma etc. Typical asthma (TA) is defined according to the history of repeated respiratory symptoms such as wheeze, shortness of breath, chest tightness, and cough, usually with reversible airflow limitation, airway hyper-responsiveness, and airway remodeling. Cough variant asthma (CVA) is characterized by the single manifestation, recurrent cough, which could be improved after the use of bronchodilators. However, according to different guidelines, it is still controversial on the treatment of CVA and TA. The guidelines of Global Initiative for Asthma(GINA) in 2014 put forward the treatment of TA patients, but did not list the treatment specific to CVA. The guideline of ACCP(American College of Chest Physicians) and cough guidelines of China are proposed to treat the CVA effectively with bronchial diastolic drug. Inhaled corticosteroids (ICS) and leukotriene receptor antagonists are effective for the treatment of CVA. Currently, more and more studies supported that application of ICS combined with bronchial dilation agents is more beneficial to CVA patients. Budesonide/formoterol is a compound of ICS and long-acting beta2-agonist(LABA), which can not only be used as a maintenance medication, but also be used as a relief medication, namely, budesonide/formoterol treatment regimen for SMART (Symbicort as both maintenance and reliever therapy). Most studies show that SMART treatment can be used in the treatment of TA patients. But the study on whether budesonide/formoterol can be used to treat CVA is still little. To provide basis for clinical medication guidance for patients with CVA and TA, this study will enroll 30 patients with TA or CVA , who will be required to adopt the SMART regimen in the following 6 months.The symptom score, airway inflammation, pulmonary function and airway reactivity changes, will be measured every mouth. After the study finished, the investigators will compare the difference between the two groups.
- Conditions
- Bronchial Asthma
- Being tested
- budesonide 160μg/formoterol 4.5μg
- Keywords
- Budesonide/formoterol, Typical asthma, Cough variant asthma
- Medical subject headings
- Asthma, Cough-Variant Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
budesonide 160μg/formoterol 4.5μgDrug
Also called Symbicort
SMART regimen
| Study group | Role | What they receive |
|---|---|---|
| patients with CVA(CVA group) | Other | budesonide 160μg and formoterol 4.5ug,1 inhalation ,twice daily ,for six months Receives: Drug: budesonide 160μg/formoterol 4.5μg |
| patients with TA(TA group) | Other | budesonide 160μg and formoterol 4.5ug,1 inhalation ,twice daily ,for six months Receives: Drug: budesonide 160μg/formoterol 4.5μg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Forced Expiratory Volume in first second
Measured: up to six months
Secondary outcomes (4)
forced vital capacity
Measured: up to six months
Fractional Exhaled Nitric Oxide
Measured: up to six months
Asthma Controlled Test
Measured: up to six months
Bronchial Provocation Test
Measured: up to six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2016 (estimated)
- Study startSep 2015
- Primary completionJan 2017 (estimated)
- Study completionMar 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bronchial 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhujiang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Huapeng Yu, Ph.D, Study director, Southern Medical University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02934945
- Sponsor's protocol ID
- 2015-HXNK-004
- Status last verified
- Jul 2016
- First submitted
- 7 Oct 2016
- Last updated
- 17 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment Efficacy of Budesonide/Formoterol in Cough Variant Asthma and Typical Asthma Patients
- ClinicalTrials.gov ID
- NCT02934945
- Acronym / sponsor ID
- 2015-HXNK-004
- Conditions
- Bronchial Asthma
- Keywords
- Budesonide/formoterol, Typical asthma, Cough variant asthma
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Zhujiang HospitalUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Jan 2017 (estimated)
- Study completion
- Mar 2017 (estimated)
- First posted
- 17 Oct 2016 (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 respiratory disease characterized by chronic airway inflammation, which have been affecting about 1-18% of the population in the world, causing tremendous economic burden for the patients and countries. Generally, asthma is a heterogeneous disease, and it could be classified into many types on the basis of symptoms, that is, typical asthma, cough variant asthma, and chest tightness variant asthma etc. Typical asthma (TA) is defined according to the history of repeated respiratory symptoms such as wheeze, shortness of breath, chest tightness, and cough, usually with reversible airflow limitation, airway hyper-responsiveness, and airway remodeling. Cough variant asthma (CVA) is characterized by the single manifestation, recurrent cough, which could be improved after the use of bronchodilators. However, according to different guidelines, it is still controversial on the treatment of CVA and TA. The guidelines of Global Initiative for Asthma(GINA) in 2014 put forward the treatment of TA patients, but did not list the treatment specific to CVA. The guideline of ACCP(American College of Chest Physicians) and cough guidelines of China are proposed to treat the CVA effectively with bronchial diastolic drug. Inhaled corticosteroids (ICS) and leukotriene receptor antagonists are effective for the treatment of CVA. Currently, more and more studies supported that application of ICS combined with bronchial dilation agents is more beneficial to CVA patients. Budesonide/formoterol is a compound of ICS and long-acting beta2-agonist(LABA), which can not only be used as a maintenance medication, but also be used as a relief medication, namely, budesonide/formoterol treatment regimen for SMART (Symbicort as both maintenance and reliever therapy). Most studies show that SMART treatment can be used in the treatment of TA patients. But the study on whether budesonide/formoterol can be used to treat CVA is still little. To provide basis for clinical medication guidance for patients with CVA and TA, this study will enroll 30 patients with TA or CVA , who will be required to adopt the SMART regimen in the following 6 months.The symptom score, airway inflammation, pulmonary function and airway reactivity changes, will be measured every mouth. After the study finished, the investigators will compare the difference between the two groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients with CVA(CVA group) | Other | Drug: budesonide 160μg/formoterol 4.5μgbudesonide 160μg and formoterol 4.5ug,1 inhalation ,twice daily ,for six months |
| patients with TA(TA group) | Other | Drug: budesonide 160μg/formoterol 4.5μgbudesonide 160μg and formoterol 4.5ug,1 inhalation ,twice daily ,for six months |
Who may qualify
- Ages
- 15 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- aged 15-75
- first diagnosed corresponding to the diagnostic standards established by Asthma Committee, Respiratory Society, Chinese Medical Association, or previously diagnosed asthma without regular treatment
- Mch bronchial provocation test is positive
- the chest X-ray is normal.
Key exclusion criteria (3 listed)
- accompanied by other disease of respiratory system
- combined with serious illness of other system, such as myocardial infarction, severe arrhythmia, malignant tumors and so on
- women with pregnancy or lactation.
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 160μg/formoterol 4.5μgAlso: SymbicortSMART regimen | Drug | patients with CVA(CVA group), patients with TA(TA group) |
Primary outcome
Forced Expiratory Volume in first second
Time frame: up to six months
4 secondary outcomes
forced vital capacity
Time frame: up to six months
Fractional Exhaled Nitric Oxide
Time frame: up to six months
Asthma Controlled Test
Time frame: up to six months
Bronchial Provocation Test
Time frame: up to six months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2016.
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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.
Jielu Liu, M.D contact
Huapeng Yu, Ph.D study director
Southern Medical University, China
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 budesonide 160μg/formoterol 4.5μg in people with Bronchial 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 3 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 17 Oct 2016. 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 Shuyu Chen, M.D (+8613580421202, 1137968694@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Forced Expiratory Volume in first second (time frame: up to six months). 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 17 Oct 2016.