Clinical Characteristics and Treatment of Chest Tightness Variant Asthma

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04322422
• Collaborator: (none)
• Enrollment: 300
• Locations: 33
• Arms: 2
• Anticipated Duration (Months): 31
• Patients Per Site: 9.1
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Asthma; Chest Syndrome; Clinical Anxiety; Clinical Depression; Lung Function; Quality of Life; Eosinophilia; Nitric Oxide; Airway Responsiveness; Induced Sputum	Drug: Inhaled corticosteriod/long-acting beta-agonist plus Montelukast; Drug: Inhaled corticosteriod/long-acting beta-agonist only	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 300 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Care Provider)
• Primary Purpose: Treatment
• Official Title: Clinical Characteristics and Treatment of Chest Tightness Variant Asthma
• Anticipated Study Start Date: Jun 1, 2020
• Anticipated Primary Completion Date: Jul 1, 2022
• Anticipated Study Completion Date: Dec 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: ICS/LABA plus Montelukast	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
Active Comparator: ICS/LABA only	Drug: Inhaled corticosteriod/long-acting beta-agonist only; Inhaled corticosteriod/long-acting beta-agonist are regular inhaled drugs for classic asthma

Outcome Measures

Primary Outcome Measures

1. Asthma control questionnaire (ACQ) [Change from baseline intervention therapy at 3 months]

   Scores of asthma control questionnaire (ACQ)

Secondary Outcome Measures

1. Forced expiratory volume in one second [Change from baseline intervention therapy at 3 months]

   Value of forced expiratory volume in one second

2. Airway responsiveness [Change from baseline intervention therapy at 3 months]

   Value of airway responsiveness

3. Peak expiratory flow [Change from baseline intervention therapy at 3 months]

   Value of peak expiratory flow

4. Asthma quality of life questionnaire [Change from baseline intervention therapy at 3 months]

   Scores of asthma quality of life questionnaire

5. Acute asthma episode [Change from baseline intervention therapy at 3 months]

   Numbers of acute asthma episode

6. Numbers of emergency or hospitalization [Change from baseline intervention therapy at 3 months]

   Numbers of emergency or hospitalization

Eligibility Criteria

Criteria

• Ages Eligible for Study: 14 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

1. bronchodilator and glucocorticoid treatment is effective;

2. 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Beijing Chao-Yang Hospital	Beijing	Beijing	China
2	China-Japan Friendship Hospital	Beijing	Beijing	China
3	Xinqiao Hospital，Third Military Medical University	Chongqing	Chongqing	China
4	The Second Affiliated Hospital，Fujian Medical University	Fuzhou	Fujian	China
5	Nanfang Hospital, Nanfang Medical University	Guangzhou	Guangdong	China
6	The First Affiliated Hospital,Guangzhou Medical University	Guangzhou	Guangdong	China
7	People's Hospital of Shenzhen	Shenzhen	Guangdong	China
8	Affiliated Hospital,Zhanjiang Medical College	Zhanjiang	Guangdong	China
9	Guizhou Provincial People's Hospital	Guiyang	Guizhou	China
10	Henan Provincial People's Hospital	Zhengzhou	Henan	China
11	Tongji Hospital，Tongji Medical College，Huazhong University of Science and Technology	Wuhan	Hubei	China
12	The Second Xiangya Hospital of Central South University	Changsha	Hunan	China
13	Xiangya Hospital of Central South University	Changsha	Hunan	China
14	Jiangsu Province Hospital	Nanjing	Jiangsu	China
15	The Central Hospital of Shenyang Military	Shenyang	Liaoning	China
16	The First Affiliated Hospital, China Medical University	Shenyang	Liaoning	China
17	Xijing Hospital	Xi'an	Shaanxi	China
18	Qilu Hospital, Shandong University	Jinan	Shandong	China
19	Shandong Provincal Hospital	Jinan	Shandong	China
20	Qingdao Municipal Hospital	Qingdao	Shandong	China
21	Weifang Asthma Hospital	Weifang	Shandong	China
22	Yantai liuhuanding Hospital	Yantai	Shandong	China
23	Changhai Hospital, Second Military Medical University	Shanghai	Shanghai	China
24	No.1 Hospital, Shanghai Jiaotong University	Shanghai	Shanghai	China
25	Ruijin Hospital, Shanghai Jiaotong University	Shanghai	Shanghai	China
26	Tongji Hospital, Tongji University	Shanghai	Shanghai	China
27	Xinhua Hospital, Shanghai Jiaotong University	Shanghai	Shanghai	China
28	Zhongshan Hospital, Fudan University	Shanghai	Shanghai	China
29	West China Hospital，Sichuan University	Chengdu	Sichuan	China
30	Second Affiliated Hospital, School of Medicine, Zhejiang University	Hangzhou	Zhejiang	China	310000
31	Sir Run Run Shaw hospital, College of Medicine，Zhejiang University	Hangzhou	Zhejiang	China
32	Huzhou Central Hospital	Huzhou	Zhejiang	China
33	The Second Affiliated Hospital,Wenzhou Medical University	Wenzhou	Zhejiang	China

Sponsors and Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Second Affiliated Hospital, School of Medicine, Zhejiang University
• ClinicalTrials.gov Identifier: NCT04322422
• Other Study ID Numbers: CTVA-ZJU
• First Posted: Mar 26, 2020
• Last Update Posted: May 12, 2020
• Last Verified: Mar 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Asthma; Eosinophilia; Montelukast

Study Results

No Results Posted as of May 12, 2020