The Efficacy of Budesonide/Formoterol in Cough Variant Asthma
Status:
Recruiting
Trial end date:
2023-05-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 4
Details
Lead Sponsor:
Second Affiliated Hospital, School of Medicine, Zhejiang University
Collaborators:
Central South University China-Japan Friendship Hospital Shanghai Tongji Hospital, Tongji University School of Medicine Shenzhen People's Hospital Tongji Hospital Zunyi Medical College
Treatments:
Budesonide Budesonide, Formoterol Fumarate Drug Combination Formoterol Fumarate