Clinical Characteristics, Treatment and Prognosis of Chest Tightness Variant Asthma

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University (Other)
• Overall Status: Completed
• CT.gov ID: NCT03237221
• Collaborator: (none)
• Enrollment: 76
• Locations: 34
• Actual Duration (Months): 67.8
• Patients Per Site: 2.2
• Patients Per Site Per Month: 0

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, we 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. In order to further understand the clinical characteristics, pathogenesis, and prognosis of patients with CTVA, we conducted a national multicenter observation study to further understand CTVA. Finally, we plan to clarify whether CTVA is a relatively independent asthma phenotype. Meanwhile, reducing misdiagnosis and perform an appropriate treatment of CTVA.

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: Treat patient according to Global Initiative for Asthma (GINA) guideline

Study Design

• Study Type: Observational
• Actual Enrollment: 76 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: Clinical Characteristics, Treatment and Prognosis of Chest Tightness Variant Asthma
• Actual Study Start Date: Mar 1, 2015
• Actual Primary Completion Date: Dec 12, 2019
• Actual Study Completion Date: Oct 23, 2020

Outcome Measures

Primary Outcome Measures

1. Asthma control questionnaire (ACQ) [Change from Baseline ACQ score at 36 months]

   Asthma control questionnaire (ACQ)

Secondary Outcome Measures

1. Forced expiratory volume in one second [Change from Baseline ACQ score at 36 months]

   Forced expiratory volume in one second

2. Airway responsiveness [Change from Baseline ACQ score at 36 months]

   Airway responsiveness

3. Peak expiratory flow [Change from Baseline ACQ score at 36 months]

   Peak expiratory flow

4. Asthma quality of life questionnaire [Change from Baseline ACQ score at 36 months]

   Asthma quality of life questionnaire

5. Acute asthma episode [Change from Baseline ACQ score at 36 months]

   Acute asthma episode

6. Numbers of emergency or hospitalization [Change from Baseline ACQ score at 36 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, 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	Beijing Tongren Hospital, Capital Medical University	Beijing	Beijing	China
3	China-Japan Friendship Hospital	Beijing	Beijing	China
4	Xinqiao Hospital，Third Military Medical University	Chongqing	Chongqing	China
5	The Second Affiliated Hospital，Fujian Medical University	Fuzhou	Fujian	China
6	Nanfang Hospital, Nanfang Medical University	Guangzhou	Guangdong	China
7	The First Affiliated Hospital,Guangzhou Medical University	Guangzhou	Guangdong	China
8	People's Hospital of Shenzhen	Shenzhen	Guangdong	China
9	Affiliated Hospital,Zhanjiang Medical College	Zhanjiang	Guangdong	China
10	Guizhou Provincial People's Hospital	Guiyang	Guizhou	China
11	Henan Provincial People's Hospital	Zhengzhou	Henan	China
12	Tongji Hospital，Tongji Medical College，Huazhong University of Science and Technology	Wuhan	Hubei	China
13	The Second Xiangya Hospital of Central South University	Changsha	Hunan	China
14	Xiangya Hospital of Central South University	Changsha	Hunan	China
15	Jiangsu Province Hospital	Nanjing	Jiangsu	China
16	The Central Hospital of Shenyang Military	Shenyang	Liaoning	China
17	The First Affiliated Hospital, China Medical University	Shenyang	Liaoning	China
18	Xijing Hospital	Xi'an	Shaanxi	China
19	Qilu Hospital, Shandong University	Jinan	Shandong	China
20	Shandong Provincal Hospital	Jinan	Shandong	China
21	Qingdao Municipal Hospital	Qingdao	Shandong	China
22	Weifang Asthma Hospital	Weifang	Shandong	China
23	Yantai liuhuanding Hospital	Yantai	Shandong	China
24	Changhai Hospital, Second Military Medical University	Shanghai	Shanghai	China
25	No.1 Hospital, Shanghai Jiaotong University	Shanghai	Shanghai	China
26	Ruijin Hospital, Shanghai Jiaotong University	Shanghai	Shanghai	China
27	Tongji Hospital, Tongji University	Shanghai	Shanghai	China
28	Xinhua Hospital, Shanghai Jiaotong University	Shanghai	Shanghai	China
29	Zhongshan Hospital, Fudan University	Shanghai	Shanghai	China
30	West China Hospital，Sichuan University	Chengdu	Sichuan	China
31	Sir Run Run Shaw hospital, College of Medicine，Zhejiang University	Hangzhou	Zhejiang	China
32	Second Affiliated Hospital, School of Medicine, Zhejiang University	Hanzhou	Zhejiang	China	310000
33	Huzhou Central Hospital	Huzhou	Zhejiang	China
34	The Second Affiliated Hospital,Wenzhou Medical University	Wenzhou	Zhejiang	China

Sponsors and Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University

Investigators

• Study Chair: Huahao Shen, Second Affiliated Hospital, School of Medicine, Zhejiang University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: yanfugui, Vice Director，Respiratory and Critical Care Medicine，Clinical Vice Professor, Second Affiliated Hospital, School of Medicine, Zhejiang University
• ClinicalTrials.gov Identifier: NCT03237221
• Other Study ID Numbers: CTVA-China
• First Posted: Aug 2, 2017
• Last Update Posted: Oct 27, 2020
• Last Verified: Oct 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

Study Results

No Results Posted as of Oct 27, 2020