The Efficacy of Budesonide/Formoterol in Cough Variant Asthma

Cough Variant Asthma Clinical Trial

Official title:

The Efficacy of Budesonide/Formoterol in Cough Variant Asthma -- A Multi-center Randomized, Controlled Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04171180
• Other study ID #: ESR-17-13270
• Status: Recruiting
• Phase: Phase 4
• Start date: May 1, 2020
• Est. completion date: May 2023

Study information

• Verified date: December 2019
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: Wen Li, Prof.
• Phone: 86-571-87783570
• Email: liwenzjhz0408[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: May 2023
• Est. primary completion date: September 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Outpatients, with age =18,=70 years old.

• Diagnose with CVA

• CSS(cough symptom score, daytime + nighttime) = 3 points

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Asthma
• Cough
• Cough Variant Asthma

Intervention

Drug:
• budesonide/formoterol
apply different dosage of budesonide/formoterol in two groups and evaluate the treatment effects.

Locations

Country	Name	City	State
China	the Second Affiliated Hospital of Zhejiang University School of Medicin	Hangzhou	Zhejiang

Sponsors (7)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University	Central South University, China-Japan Friendship Hospital, Shanghai Tongji Hospital, Tongji University School of Medicine, Shenzhen People's Hospital, Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology, Zunyi Medical College

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	change in lung function	value of pulmonary function index such as FEV1% Pred, FVC% Pred, PD20-FEV1 and PEF	during 6-months' follow-up phase
Other	assess different phenotypes of CVA	investigate inflammation characteristics consist of differential count of inflammatory cells in induced sputum	during 6-months' follow-up phase
Other	assess safety of different doses of budesonide/formoterol	evaluate adverse events of different doses of budesonide/formoterol	during 6-months' follow-up phase
Primary	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	the proportion of CVA patient with symptom relief	symptom relief rate after treating by different doses of budesonide/formoterol for 3 months.	after treating by different doses of budesonide/formoterol for 3 months.