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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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.

Shuyu Chen, M.D contact

+8613580421202

1137968694@qq.com

Jielu Liu, M.D contact

China1 site, 1 recruiting
  • Zhujiang Hospital of Southern Medical University

    Guangzhou, Guangdong, 510282

    Shuyu Chen, M.D, 13580421202, 1137968694@qq.com

    Jielu Liu, M.D

    Recruiting

Other trials in China

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.

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 groups in NCT02934945
Study groupRoleWhat they receive
patients with CVA(CVA group)Otherbudesonide 160μg and formoterol 4.5ug,1 inhalation ,twice daily ,for six months
Receives: Drug: budesonide 160μg/formoterol 4.5μg
patients with TA(TA group)Otherbudesonide 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.

  1. Forced Expiratory Volume in first second

    Measured: up to six months

Secondary outcomes (4)
  1. forced vital capacity

    Measured: up to six months

  2. Fractional Exhaled Nitric Oxide

    Measured: up to six months

  3. Asthma Controlled Test

    Measured: up to six months

  4. 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.

  1. First posted17 Oct 2016 (estimated)
  2. Study startSep 2015
  3. Primary completionJan 2017 (estimated)
  4. Study completionMar 2017 (estimated)

Resources

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)
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

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.

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