Clinical Characteristics, Treatment and Prognosis of Chest Tightness Variant Asthma

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.

Study Overview

• Status: Completed
• Conditions: Quality of Life; Asthma; Eosinophilia; Nitric Oxide; Airway Responsiveness; Clinical Depression; Chest Syndrome; Lung Function; Clinical Anxiety; Induced Sputum
• Intervention / Treatment: Drug: Treat patient according to Global Initiative for Asthma (GINA) guideline

• Study Type: Observational
• Enrollment (Actual): 76

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China
      • China-Japan Friendship Hospital
    • Beijing, Beijing, China
      • Beijing Tongren Hospital, Capital Medical University
    • Beijing, Beijing, China
      • Beijing Chao-Yang Hospital
  • Chongqing
    • Chongqing, Chongqing, China
      • Xinqiao Hospital，Third Military Medical University
  • Fujian
    • Fuzhou, Fujian, China
      • The Second Affiliated Hospital，Fujian Medical University
  • Guangdong
    • Guangzhou, Guangdong, China
      • The First Affiliated Hospital,Guangzhou Medical University
    • Guangzhou, Guangdong, China
      • Nanfang Hospital, Nanfang Medical University
    • Shenzhen, Guangdong, China
      • People's Hospital of Shenzhen
    • Zhanjiang, Guangdong, China
      • Affiliated Hospital,Zhanjiang Medical College
  • Guizhou
    • Guiyang, Guizhou, China
      • Guizhou Provincial People's Hospital
  • Henan
    • Zhengzhou, Henan, China
      • HeNan Provincial People's Hospital
  • Hubei
    • Wuhan, Hubei, China
      • Tongji Hospital,Tongji Medical College,Huazhong University of Science and Technology
  • Hunan
    • Changsha, Hunan, China
      • The Second Xiangya Hospital of Central South University
    • Changsha, Hunan, China
      • Xiangya Hospital of Central South University
  • Jiangsu
    • Nanjing, Jiangsu, China
      • Jiangsu Province Hospital
  • Liaoning
    • Shenyang, Liaoning, China
      • The Central Hospital of Shenyang Military
    • Shenyang, Liaoning, China
      • The First Affiliated Hospital, China Medical University
  • Shaanxi
    • Xi'an, Shaanxi, China
      • Xijing Hospital
  • Shandong
    • Jinan, Shandong, China
      • Qilu Hospital, Shandong University
    • Jinan, Shandong, China
      • Shandong Provincal Hospital
    • Qingdao, Shandong, China
      • QingDao Municipal Hospital
    • Weifang, Shandong, China
      • Weifang Asthma Hospital
    • Yantai, Shandong, China
      • Yantai liuhuanding Hospital
  • Shanghai
    • Shanghai, Shanghai, China
      • Zhongshan Hospital, Fudan University
    • Shanghai, Shanghai, China
      • Changhai Hospital, Second Military Medical University
    • Shanghai, Shanghai, China
      • Ruijin Hospital, Shanghai Jiaotong University
    • Shanghai, Shanghai, China
      • No.1 Hospital, Shanghai Jiaotong University
    • Shanghai, Shanghai, China
      • Tongji Hospital, Tongji University
    • Shanghai, Shanghai, China
      • Xinhua Hospital, Shanghai Jiaotong University
  • Sichuan
    • Chengdu, Sichuan, China
      • West China Hospital,Sichuan University
  • Zhejiang
    • Hangzhou, Zhejiang, China
      • Sir Run Run Shaw hospital, College of Medicine，Zhejiang University
    • Hanzhou, Zhejiang, China, 310000
      • Second Affiliated Hospital, School of Medicine, Zhejiang University
    • Huzhou, Zhejiang, China
      • Huzhou Central Hospital
    • Wenzhou, Zhejiang, China
      • The Second Affiliated Hospital,Wenzhou Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 80 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients with only symptom of chest tightness and bronchial provocation test positive according to eligibility criteria.

Description

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, 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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Asthma control questionnaire (ACQ)	Asthma control questionnaire (ACQ)	Change from Baseline ACQ score at 36 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Forced expiratory volume in one second	Forced expiratory volume in one second	Change from Baseline ACQ score at 36 months
Airway responsiveness	Airway responsiveness	Change from Baseline ACQ score at 36 months
Peak expiratory flow	Peak expiratory flow	Change from Baseline ACQ score at 36 months
Asthma quality of life questionnaire	Asthma quality of life questionnaire	Change from Baseline ACQ score at 36 months
Acute asthma episode	Acute asthma episode	Change from Baseline ACQ score at 36 months
Numbers of emergency or hospitalization	Numbers of emergency or hospitalization	Change from Baseline ACQ score at 36 months

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2015
• Primary Completion (Actual): December 12, 2019
• Study Completion (Actual): October 23, 2020

Study Registration Dates

• First Submitted: July 24, 2017
• First Submitted That Met QC Criteria: July 28, 2017
• First Posted (Actual): August 2, 2017

Study Record Updates

• Last Update Posted (Actual): October 27, 2020
• Last Update Submitted That Met QC Criteria: October 24, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Hematologic Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Leukocyte Disorders; Asthma; Eosinophilia
• Other Study ID Numbers: CTVA-China

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No