Cough Variant AsthmaPhase 4NCT04171180
The Efficacy of Budesonide/Formoterol in Cough Variant Asthma
A Phase 4 study testing budesonide/formoterol in people with Cough Variant Asthma, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
Cough variant asthma (CVA), subtype of bronchial asthma, is considered to be one of the most common causes of chronic cough in different cough guidelines of United States, Europe, China and other countries. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Cough Variant Asthma
- What is being tested?
- budesonide/formoterol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2020to May 2023
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Outpatients, with age ≥18，≤70 years old.
- Diagnose with CVA
- CSS(cough symptom score, daytime + nighttime) ≥ 3 points
Who cannot join
- Participated in any interventional clinical trial during the last 90 days.
- Pregnancy
- Associated with a clear history of other lung diseases, or combined with other systems severe illness.
- A abuse history of alcohol or narcotic drug, or have a mental history, confrontation personality, adverse motives, suspicious or other emotional or intellectual problems that may affect the informed validity of the study
- With a history of upper respiratory tract infection acute exacerbation within 4 weeks before enrolment.
- Clinical abnormalities associated with symptoms in chest radiology.
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- Smokers
- On medications of ACEI or ARB
- Not suitable for study observation judged by investigators
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
the Second Affiliated Hospital of Zhejiang University School of Medicin
Hangzhou, Zhejiang, 310000
Wen Li, Prof.
Huahao Shen, Prof.
About this study
Official title: The Efficacy of Budesonide/Formoterol in Cough Variant Asthma -- A Multi-center Randomized, Controlled Clinical Trial
Cough variant asthma (CVA), subtype of bronchial asthma, is considered to be one of the most common causes of chronic cough in different cough guidelines of United States, Europe, China and other countries. From a multicenter survey in China, over one third of chronic cough is caused by CVA, which is higher than western countries. CVA differs from classic asthma, usually manifesting a symptom of only coughing without wheezing or dyspnea and particularly coughing at night. With less clinical manifestation and medical intervention, CVA patients are easily be neglected and misdiagnosed, and 30-40% of them will develop to typical asthma in the next few years. Currently there's no specific therapy recommendation for CVA in GINA. Although cough guidelines in China recommend that CVA patients should be treated as typical asthma, no recommendation on details about ICS/LABA dosage and duration. There are only a few sporadic CVA therapy researches with small sample size. Two studiesfound that CVA patients can't get cough symptom relief even after treating by low dose of ICS/LABA for 3 months. Some patients' cough symptom relapses during the 24-week follow-up phase after treating by ICS/LABA for 3 months. Overall, the best treatment of CVA is not yet clear.
GINA 2018 emphasize that asthma need long-term management. Euro-SMART study found that budesonide/formoterol 2 inhalation twice daily plus as needed can reduce daytime asthma symptoms and night-time awakenings, as well as reduce exacerbation risk more than 1 inhalation twice daily. Based on the above reasons, We assume that increase the dosage of ICS/LABA can decrease relapse rate in CVA patients with severe cough. This multi-center, randomized, controlled clinical trial can help to clarify the best dosage of budesonide/formoterol of CVA in China.
- Conditions
- Cough Variant Asthma
- Being tested
- budesonide/formoterol
- Medical subject headings
- Cough-Variant Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
budesonide/formoterolDrug
apply different dosage of budesonide/formoterol in two groups and evaluate the treatment effects.
| Study group | Role | What they receive |
|---|---|---|
| Controlled group | Active comparator | Controlled group: budesonide/formoterol(SYM) 160/4.5ug 1 inhalation bid* 3 months (n=250). Receives: Drug: budesonide/formoterol |
| Study group | Experimental | Study group: SYM 160/4.5ug 2 inhalation bid* 3 months (n=250). Receives: Drug: budesonide/formoterol |
What is being measured
The primary outcome is the main question the study is designed to answer.
the proportion of CVA patient with symptom relapse
Relapse rate during the 6-months' follow-up phase after treating by different doses of budesonide/formoterol for 3 months.
Measured: during 6-months' follow-up phase
Secondary outcomes (1)
the proportion of CVA patient with symptom relief
symptom relief rate after treating by different doses of budesonide/formoterol for 3 months.
Measured: after treating by different doses of budesonide/formoterol for 3 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2019
- Study start1 May 2020 (estimated)
- Primary completionSep 2020 (estimated)
- Study completionMay 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cough Variant AsthmaStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Tongji Hospital, Tongji University School of Medicine, Tongji Hospital, Zunyi Medical College, Central South University, China-Japan Friendship Hospital, Shenzhen People's Hospital
- Responsible party
- Sponsor
- Investigators
- Huahao Shen, Prof., Principal investigator, the Second Affiliated Hospital of Zhejiang University School of Medicin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04171180
- Sponsor's protocol ID
- ESR-17-13270
- Status last verified
- Dec 2019
- First submitted
- 21 Apr 2019
- Last updated
- 12 May 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Budesonide/Formoterol in Cough Variant Asthma -- A Multi-center Randomized, Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT04171180
- Acronym / sponsor ID
- ESR-17-13270
- Conditions
- Cough Variant Asthma
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Collaborators
- Shanghai Tongji Hospital, Tongji University School of Medicine, Tongji Hospital, Zunyi Medical College, Central South University, China-Japan Friendship Hospital, Shenzhen People's Hospital
- Study start
- 1 May 2020 (estimated)
- Primary completion
- Sep 2020 (estimated)
- Study completion
- May 2023 (estimated)
- First posted
- 20 Nov 2019 (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.
Cough variant asthma (CVA), subtype of bronchial asthma, is considered to be one of the most common causes of chronic cough in different cough guidelines of United States, Europe, China and other countries. From a multicenter survey in China, over one third of chronic cough is caused by CVA, which is higher than western countries. CVA differs from classic asthma, usually manifesting a symptom of only coughing without wheezing or dyspnea and particularly coughing at night. With less clinical manifestation and medical intervention, CVA patients are easily be neglected and misdiagnosed, and 30-40% of them will develop to typical asthma in the next few years. Currently there's no specific therapy recommendation for CVA in GINA. Although cough guidelines in China recommend that CVA patients should be treated as typical asthma, no recommendation on details about ICS/LABA dosage and duration. There are only a few sporadic CVA therapy researches with small sample size. Two studiesfound that CVA patients can't get cough symptom relief even after treating by low dose of ICS/LABA for 3 months. Some patients' cough symptom relapses during the 24-week follow-up phase after treating by ICS/LABA for 3 months. Overall, the best treatment of CVA is not yet clear.
GINA 2018 emphasize that asthma need long-term management. Euro-SMART study found that budesonide/formoterol 2 inhalation twice daily plus as needed can reduce daytime asthma symptoms and night-time awakenings, as well as reduce exacerbation risk more than 1 inhalation twice daily. Based on the above reasons, We assume that increase the dosage of ICS/LABA can decrease relapse rate in CVA patients with severe cough. This multi-center, randomized, controlled clinical trial can help to clarify the best dosage of budesonide/formoterol of CVA in China.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Controlled group | Active comparator | Drug: budesonide/formoterolControlled group: budesonide/formoterol(SYM) 160/4.5ug 1 inhalation bid* 3 months (n=250). |
| Study group | Experimental | Drug: budesonide/formoterolStudy group: SYM 160/4.5ug 2 inhalation bid* 3 months (n=250). |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Outpatients, with age ≥18，≤70 years old.
- Diagnose with CVA
- CSS(cough symptom score, daytime + nighttime) ≥ 3 points
Key exclusion criteria (9 listed)
- Participated in any interventional clinical trial during the last 90 days.
- Pregnancy
- Associated with a clear history of other lung diseases, or combined with other systems severe illness.
- A abuse history of alcohol or narcotic drug, or have a mental history, confrontation personality, adverse motives, suspicious or other emotional or intellectual problems that may affect the informed validity of the study
- With a history of upper respiratory tract infection acute exacerbation within 4 weeks before enrolment.
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/formoterolapply different dosage of budesonide/formoterol in two groups and evaluate the treatment effects. | Drug | Controlled group, Study group |
Primary outcome
the proportion of CVA patient with symptom relapse
Time frame: during 6-months' follow-up phase
Relapse rate during the 6-months' follow-up phase after treating by different doses of budesonide/formoterol for 3 months.
1 secondary outcome
the proportion of CVA patient with symptom relief
Time frame: after treating by different doses of budesonide/formoterol for 3 months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2020.
Related trials for Cough Variant 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.
Huahao Shen, Prof. principal investigator
the Second Affiliated Hospital of Zhejiang University School of Medicin
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/formoterol in people with Cough Variant Asthma, run by Second Affiliated Hospital, Zhejiang University, School of Medicine 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 9 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 12 May 2020. 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 Wen Li, Prof. (86-571-87783570, liwenzjhz0408@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the proportion of CVA patient with symptom relapse (time frame: during 6-months' follow-up phase). 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 12 May 2020.