The Efficacy of Budesonide/Formoterol in Cough Variant Asthma

NCT ID: NCT04171180

Last Updated: 2020-05-12

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 500 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-05-01
• Study Completion Date: 2023-05-31

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.

Conditions

Cough Variant Asthma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Controlled group

Controlled group: budesonide/formoterol(SYM) 160/4.5ug 1 inhalation bid\* 3 months (n=250).

Group Type: ACTIVE_COMPARATOR

budesonide/formoterol

Intervention Type: DRUG

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

Study group

Study group: SYM 160/4.5ug 2 inhalation bid\* 3 months (n=250).

Group Type: EXPERIMENTAL

budesonide/formoterol

Intervention Type: DRUG

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

Interventions

budesonide/formoterol

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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Tongji Hospital, Tongji University School of Medicine

OTHER

Sponsor Role: collaborator

Tongji Hospital

OTHER

Sponsor Role: collaborator

Zunyi Medical College

OTHER

Sponsor Role: collaborator

Central South University

OTHER

Sponsor Role: collaborator

China-Japan Friendship Hospital

OTHER

Sponsor Role: collaborator

Shenzhen People's Hospital

OTHER

Sponsor Role: collaborator

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Huahao Shen, Prof.

Role: PRINCIPAL_INVESTIGATOR

the Second Affiliated Hospital of Zhejiang University School of Medicin

Locations

the Second Affiliated Hospital of Zhejiang University School of Medicin

Hangzhou, Zhejiang, China

Site Status: RECRUITING

Countries

China

Central Contacts

Wen Li, Prof.

Role: CONTACT

liwenzjhz0408@163.com

86-571-87783570

Facility Contacts

Wen Li, Prof.

Role: primary

Other Identifiers

ESR-17-13270

Identifier Type: -

Identifier Source: org_study_id