Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04322422
Other study ID # CTVA-ZJU
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date June 1, 2020
Est. completion date December 31, 2022

Study information

Verified date March 2020
Source Second Affiliated Hospital, School of Medicine, Zhejiang University
Contact fugui Yan
Phone 13757158676
Email yfg0726@163.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Asthma, abbreviation for bronchial asthma, is one of the common chronic airways disease that threatens human health. Typical symptoms of asthma are recurrent wheezing, shortness of breath, chest tightness and cough, usually occurring at night or early morning. However, there are still some patients with only persistent clinical manifestations of chest tightness. Concerned about this group of patients, investigators presented a subgroup of bronchial asthma, namely, chest tightness variant asthma (CTVA). This asthma subgroup usually lacks asthma-specific clinical features such as wheezing, shortness of breath, wheezing, and therefore often misdiagnosed for a long time. However, there is lack of definite treatment strategy for CTVA. In order to further understand the clinical characteristics and treatment of patients with CTVA, investigators conducted a national multicenter randomized control trial(RCT) study that compares inhaled corticosteroid(ICS)/ long-acting beta2-agonist(LABA) + Montelukast with ICS/LABA. Finally, investigators plan to clarify whether ICS/LABA plus Montelukast is more appropriate treatment than only ICS/LABA in CTVA patients.


Recruitment information / eligibility

Status Recruiting
Enrollment 300
Est. completion date December 31, 2022
Est. primary completion date July 1, 2022
Accepts healthy volunteers No
Gender All
Age group 14 Years to 80 Years
Eligibility Inclusion Criteria:

1. all subjects agreed to participate, understand the project, observe the use of drugs, agree to follow-up, and signed informed consent;

2. the age of more than 14 and less 80 years old, gender and ethnicity are not limited;

3. the duration time was more than 6 months,and chest tightness was the only complaint, without breathing, short of breath, chronic cough;

4. no wheezing;

5. a diagnosis of asthma supported by one or more other characteristics:

- bronchial provocation test positive;

- improvement in forced expiratory volume at one second (FEV1) of more than 12% and 200 mL after inhaled salbutamol;

- variability in diurnal peak expiratory flow (PEF) of more than 10% for one day during one week.

6. bronchodilator and glucocorticoid treatment is effective;

7. exclude the following diseases by the corresponding doctors: coronary heart disease, myocarditis, heart failure, gastroesophageal reflux disease(GERD), neuromuscular disease, and mental disease.

Exclusion Criteria:

1. can not cooperate with related inspection or for other reasons;

2. patients with chronic obstructive pulmonary disease, interstitial pneumonia, active tuberculosis, community acquired pneumonia, lung cancer, bronchiectasis, cor pulmonale, pulmonary embolism, and accompanied with serious systematic disease (such as coronary heart disease, myocarditis, heart failure, gastroesophageal reflux disease, neuromuscular disease, etc);

3. history of drug abuse, alcohol abuse or anesthesia or with a history of mental illness (schizophrenia, obsessive-compulsive disorder, depression) and against personality, motivation, suspicious, or other emotional or mental issues that may affect participation in the study;

4. taking part in other drug clinical trial project, or drop out less than 3 months;

5. during pregnancy, lactation women;

6. obvious abnormal of High Resolution CT.

Study Design


Intervention

Drug:
Inhaled corticosteriod/long-acting beta-agonist plus Montelukast
Inhaled corticosteriod/long-acting beta-agonist are regular inhaled drugs for classic asthma; Montelukast is benefitial for allergic disease
Inhaled corticosteriod/long-acting beta-agonist only
Inhaled corticosteriod/long-acting beta-agonist are regular inhaled drugs for classic asthma

Locations

Country Name City State
China Beijing Chao-Yang Hospital Beijing Beijing
China China-Japan Friendship Hospital Beijing Beijing
China The Second Xiangya Hospital of Central South University Changsha Hunan
China Xiangya Hospital of Central South University Changsha Hunan
China West China Hospital,Sichuan University Chengdu Sichuan
China Xinqiao Hospital,Third Military Medical University Chongqing Chongqing
China The Second Affiliated Hospital,Fujian Medical University Fuzhou Fujian
China Nanfang Hospital, Nanfang Medical University Guangzhou Guangdong
China The First Affiliated Hospital,Guangzhou Medical University Guangzhou Guangdong
China Guizhou Provincial People's Hospital Guiyang Guizhou
China Second Affiliated Hospital, School of Medicine, Zhejiang University Hangzhou Zhejiang
China Sir Run Run Shaw hospital, College of Medicine,Zhejiang University Hangzhou Zhejiang
China Huzhou Central Hospital Huzhou Zhejiang
China Qilu Hospital, Shandong University Jinan Shandong
China Shandong Provincal Hospital Jinan Shandong
China Jiangsu Province Hospital Nanjing Jiangsu
China Qingdao Municipal Hospital Qingdao Shandong
China Changhai Hospital, Second Military Medical University Shanghai Shanghai
China No.1 Hospital, Shanghai Jiaotong University Shanghai Shanghai
China Ruijin Hospital, Shanghai Jiaotong University Shanghai Shanghai
China Tongji Hospital, Tongji University Shanghai Shanghai
China Xinhua Hospital, Shanghai Jiaotong University Shanghai Shanghai
China Zhongshan Hospital, Fudan University Shanghai Shanghai
China The Central Hospital of Shenyang Military Shenyang Liaoning
China The First Affiliated Hospital, China Medical University Shenyang Liaoning
China People's Hospital of Shenzhen Shenzhen Guangdong
China Weifang Asthma Hospital Weifang Shandong
China The Second Affiliated Hospital,Wenzhou Medical University Wenzhou Zhejiang
China Tongji Hospital,Tongji Medical College,Huazhong University of Science and Technology Wuhan Hubei
China Xijing Hospital Xi'an Shaanxi
China Yantai liuhuanding Hospital Yantai Shandong
China Affiliated Hospital,Zhanjiang Medical College Zhanjiang Guangdong
China Henan Provincial People's Hospital Zhengzhou Henan

Sponsors (1)

Lead Sponsor Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Asthma control questionnaire (ACQ) Scores of asthma control questionnaire (ACQ) Change from baseline intervention therapy at 3 months
Secondary Forced expiratory volume in one second Value of forced expiratory volume in one second Change from baseline intervention therapy at 3 months
Secondary Airway responsiveness Value of airway responsiveness Change from baseline intervention therapy at 3 months
Secondary Peak expiratory flow Value of peak expiratory flow Change from baseline intervention therapy at 3 months
Secondary Asthma quality of life questionnaire Scores of asthma quality of life questionnaire Change from baseline intervention therapy at 3 months
Secondary Acute asthma episode Numbers of acute asthma episode Change from baseline intervention therapy at 3 months
Secondary Numbers of emergency or hospitalization Numbers of emergency or hospitalization Change from baseline intervention therapy at 3 months
See also
  Status Clinical Trial Phase
Terminated NCT04410523 - Study of Efficacy and Safety of CSJ117 in Patients With Severe Uncontrolled Asthma Phase 2
Completed NCT04624425 - Additional Effects of Segmental Breathing In Asthma N/A
Active, not recruiting NCT03927820 - A Pharmacist-Led Intervention to Increase Inhaler Access and Reduce Hospital Readmissions (PILLAR) N/A
Completed NCT04617015 - Defining and Treating Depression-related Asthma Early Phase 1
Recruiting NCT03694158 - Investigating Dupilumab's Effect in Asthma by Genotype Phase 4
Terminated NCT04946318 - Study of Safety of CSJ117 in Participants With Moderate to Severe Uncontrolled Asthma Phase 2
Completed NCT04450108 - Vivatmo Pro™ for Fractional Exhaled Nitric Oxide (FeNO) Monitoring in U.S. Asthmatic Patients N/A
Completed NCT03086460 - A Dose Ranging Study With CHF 1531 in Subjects With Asthma (FLASH) Phase 2
Completed NCT01160224 - Oral GW766944 (Oral CCR3 Antagonist) Phase 2
Completed NCT03186209 - Efficacy and Safety Study of Benralizumab in Patients With Uncontrolled Asthma on Medium to High Dose Inhaled Corticosteroid Plus LABA (MIRACLE) Phase 3
Completed NCT02502734 - Effect of Inhaled Fluticasone Furoate on Short-term Growth in Paediatric Subjects With Asthma Phase 3
Completed NCT01715844 - L-Citrulline Supplementation Pilot Study for Overweight Late Onset Asthmatics Phase 1
Terminated NCT04993443 - First-In-Human Study to Evaluate the Safety, Tolerability, Immunogenicity, and Pharmacokinetics of LQ036 Phase 1
Completed NCT02787863 - Clinical and Immunological Efficiency of Bacterial Vaccines at Adult Patients With Bronchopulmonary Pathology Phase 4
Recruiting NCT06033833 - Long-term Safety and Efficacy Evaluation of Subcutaneous Amlitelimab in Adult Participants With Moderate-to-severe Asthma Who Completed Treatment Period of Previous Amlitelimab Asthma Clinical Study Phase 2
Completed NCT03257995 - Pharmacodynamics, Safety, Tolerability, and Pharmacokinetics of Two Orally Inhaled Indacaterol Salts in Adult Subjects With Asthma. Phase 2
Completed NCT02212483 - Clinical Effectiveness and Economical Impact of Medical Indoor Environment Counselors Visiting Homes of Asthma Patients N/A
Recruiting NCT04872309 - MUlti-nuclear MR Imaging Investigation of Respiratory Disease-associated CHanges in Lung Physiology
Withdrawn NCT01468805 - Childhood Asthma Reduction Study N/A
Recruiting NCT05145894 - Differentiation of Asthma/COPD Exacerbation and Stable State Using Automated Lung Sound Analysis With LungPass Device