The Efficacy of Budesonide/Formoterol in Cough Variant Asthma
1 other identifier
interventional
500
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started May 2020
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 21, 2019
CompletedFirst Posted
Study publicly available on registry
November 20, 2019
CompletedStudy Start
First participant enrolled
May 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2023
CompletedMay 12, 2020
December 1, 2019
4 months
April 21, 2019
May 9, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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.
during 6-months' follow-up phase
Secondary Outcomes (1)
the proportion of CVA patient with symptom relief
after treating by different doses of budesonide/formoterol for 3 months.
Other Outcomes (3)
change in lung function
during 6-months' follow-up phase
assess different phenotypes of CVA
during 6-months' follow-up phase
assess safety of different doses of budesonide/formoterol
during 6-months' follow-up phase
Study Arms (2)
Controlled group
ACTIVE COMPARATORControlled group: budesonide/formoterol(SYM) 160/4.5ug 1 inhalation bid\* 3 months (n=250).
Study group
EXPERIMENTALStudy group: SYM 160/4.5ug 2 inhalation bid\* 3 months (n=250).
Interventions
apply different dosage of budesonide/formoterol in two groups and evaluate the treatment effects.
Eligibility Criteria
You may qualify if:
- Outpatients, with age ≥18，≤70 years old.
- Diagnose with CVA
- CSS(cough symptom score, daytime + nighttime) ≥ 3 points
You may not qualify if:
- 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.
- Smokers
- On medications of ACEI or ARB
- Not suitable for study observation judged by investigators
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Second Affiliated Hospital, School of Medicine, Zhejiang Universitylead
- Shanghai Tongji Hospital, Tongji University School of Medicinecollaborator
- Tongji Hospitalcollaborator
- Zunyi Medical Collegecollaborator
- Central South Universitycollaborator
- China-Japan Friendship Hospitalcollaborator
- Shenzhen People's Hospitalcollaborator
Study Sites (1)
the Second Affiliated Hospital of Zhejiang University School of Medicin
Hangzhou, Zhejiang, 310000, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Huahao Shen, Prof.
the Second Affiliated Hospital of Zhejiang University School of Medicin
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 21, 2019
First Posted
November 20, 2019
Study Start
May 1, 2020
Primary Completion
September 1, 2020
Study Completion
May 1, 2023
Last Updated
May 12, 2020
Record last verified: 2019-12