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Clinical Characteristics, Treatment and Prognosis of Chest Tightness Variant Asthma

NCT03237221 — Completed, 76 participants, Second Affiliated Hospital, Zhejiang University, School of Medicine

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RegistryNCT03237221
StatusCompleted
Study typeObservational
Enrollment76 (Actual)
SponsorSecond Affiliated Hospital, Zhejiang University, School of Medicine (Other)
ConditionsAsthma, Chest Syndrome, Clinical Anxiety, Clinical Depression, Lung Function, Quality of Life, Eosinophilia, Nitric Oxide, Airway Responsiveness, Induced Sputum
InterventionsTreat patient according to Global Initiative for Asthma (GINA) guideline (Drug)
Datesstart 2015-03-01, primary completion 2019-12-12, completion 2020-10-23, first posted 2017-08-02, last updated 2020-10-27
Locations34 sites in China

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-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.

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+Arms and interventions

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

+Outcome measures

Primary outcomes

  • Asthma control questionnaire (ACQ) [Change from Baseline ACQ score at 36 months]: Asthma control questionnaire (ACQ)

Secondary outcomes

  • Forced expiratory volume in one second [Change from Baseline ACQ score at 36 months]: Forced expiratory volume in one second
  • Airway responsiveness [Change from Baseline ACQ score at 36 months]: Airway responsiveness
  • Peak expiratory flow [Change from Baseline ACQ score at 36 months]: Peak expiratory flow
  • Asthma quality of life questionnaire [Change from Baseline ACQ score at 36 months]: Asthma quality of life questionnaire
  • Acute asthma episode [Change from Baseline ACQ score at 36 months]: Acute asthma episode
  • Numbers of emergency or hospitalization [Change from Baseline ACQ score at 36 months]: Numbers of emergency or hospitalization

+Eligibility

Sex: All, ages: 14 Years to 80 Years

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.

+Locations (34)

FacilityCityCountryStatus
Beijing Chao-Yang HospitalBeijing, Beijing MunicipalityChina
Beijing Tongren Hospital, Capital Medical UniversityBeijing, Beijing MunicipalityChina
China-Japan Friendship HospitalBeijing, Beijing MunicipalityChina
Xinqiao Hospital,Third Military Medical UniversityChongqing, Chongqing MunicipalityChina
The Second Affiliated Hospital,Fujian Medical UniversityFuzhou, FujianChina
Nanfang Hospital, Nanfang Medical UniversityGuangzhou, GuangdongChina
The First Affiliated Hospital,Guangzhou Medical UniversityGuangzhou, GuangdongChina
People's Hospital of ShenzhenShenzhen, GuangdongChina
Affiliated Hospital,Zhanjiang Medical CollegeZhanjiang, GuangdongChina
Guizhou Provincial People's HospitalGuiyang, GuizhouChina
Henan Provincial People's HospitalZhengzhou, HenanChina
Tongji Hospital,Tongji Medical College,Huazhong University of Science and TechnologyWuhan, HubeiChina
The Second Xiangya Hospital of Central South UniversityChangsha, HunanChina
Xiangya Hospital of Central South UniversityChangsha, HunanChina
Jiangsu Province HospitalNanjing, JiangsuChina
The Central Hospital of Shenyang MilitaryShenyang, LiaoningChina
The First Affiliated Hospital, China Medical UniversityShenyang, LiaoningChina
Xijing HospitalXi'an, ShaanxiChina
Qilu Hospital, Shandong UniversityJinan, ShandongChina
Shandong Provincal HospitalJinan, ShandongChina
Qingdao Municipal HospitalQingdao, ShandongChina
Weifang Asthma HospitalWeifang, ShandongChina
Yantai liuhuanding HospitalYantai, ShandongChina
Changhai Hospital, Second Military Medical UniversityShanghai, Shanghai MunicipalityChina
No.1 Hospital, Shanghai Jiaotong UniversityShanghai, Shanghai MunicipalityChina
Ruijin Hospital, Shanghai Jiaotong UniversityShanghai, Shanghai MunicipalityChina
Tongji Hospital, Tongji UniversityShanghai, Shanghai MunicipalityChina
Xinhua Hospital, Shanghai Jiaotong UniversityShanghai, Shanghai MunicipalityChina
Zhongshan Hospital, Fudan UniversityShanghai, Shanghai MunicipalityChina
West China Hospital,Sichuan UniversityChengdu, SichuanChina
Sir Run Run Shaw hospital, College of Medicine,Zhejiang UniversityHangzhou, ZhejiangChina
Second Affiliated Hospital, School of Medicine, Zhejiang UniversityHanzhou, ZhejiangChina
Huzhou Central HospitalHuzhou, ZhejiangChina
The Second Affiliated Hospital,Wenzhou Medical UniversityWenzhou, ZhejiangChina

+Investigators

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

My Notes