Clinical Characteristics and Treatment of Chest Tightness Variant Asthma

NCT04322422 — Not applicable, Unknown, 300 participants, Second Affiliated Hospital, Zhejiang University, School of Medicine

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RegistryNCT04322422
StatusUnknown
PhaseNot applicable
Study typeInterventional; randomized, parallel, masking: double, treatment
Enrollment300 (Estimated)
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
InterventionsInhaled corticosteriod/long-acting beta-agonist plus Montelukast, Inhaled corticosteriod/long-acting beta-agonist only (Drug)
Datesstart 2020-06-01 (estimated), primary completion 2022-07-01 (estimated), completion 2022-12-31 (estimated), first posted 2020-03-26, last updated 2020-05-12
Locations33 sites in China

Related Papers Related Patents Related Grants Related Experts
All trials for Asthma All trials for Chest Syndrome All trials of Inhaled corticosteriod/long-acting beta-agonist plus Montelukast All trials of Inhaled corticosteriod/long-acting beta-agonist only

-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.

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+Arms and interventions

ArmTypeInterventionsDescription
ICS/LABA plus MontelukastExperimentalDrug: Inhaled corticosteriod/long-acting beta-agonist plus Montelukast
ICS/LABA onlyActive comparatorDrug: Inhaled corticosteriod/long-acting beta-agonist only
  • Inhaled corticosteriod/long-acting beta-agonist plus Montelukast (Drug): 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 (Drug): Inhaled corticosteriod/long-acting beta-agonist are regular inhaled drugs for classic asthma

+Outcome measures

Primary outcomes

  • Asthma control questionnaire (ACQ) [Change from baseline intervention therapy at 3 months]: Scores of asthma control questionnaire (ACQ)

Secondary outcomes

  • Forced expiratory volume in one second [Change from baseline intervention therapy at 3 months]: Value of forced expiratory volume in one second
  • Airway responsiveness [Change from baseline intervention therapy at 3 months]: Value of airway responsiveness
  • Peak expiratory flow [Change from baseline intervention therapy at 3 months]: Value of peak expiratory flow
  • Asthma quality of life questionnaire [Change from baseline intervention therapy at 3 months]: Scores of asthma quality of life questionnaire
  • Acute asthma episode [Change from baseline intervention therapy at 3 months]: Numbers of acute asthma episode
  • Numbers of emergency or hospitalization [Change from baseline intervention therapy at 3 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, 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.

+Locations (33)

FacilityCityCountryStatus
Beijing Chao-Yang HospitalBeijing, Beijing MunicipalityChinaRecruiting
China-Japan Friendship HospitalBeijing, Beijing MunicipalityChinaRecruiting
Xinqiao Hospital,Third Military Medical UniversityChongqing, Chongqing MunicipalityChinaRecruiting
The Second Affiliated Hospital,Fujian Medical UniversityFuzhou, FujianChinaRecruiting
Nanfang Hospital, Nanfang Medical UniversityGuangzhou, GuangdongChinaRecruiting
The First Affiliated Hospital,Guangzhou Medical UniversityGuangzhou, GuangdongChinaRecruiting
People's Hospital of ShenzhenShenzhen, GuangdongChinaRecruiting
Affiliated Hospital,Zhanjiang Medical CollegeZhanjiang, GuangdongChinaRecruiting
Guizhou Provincial People's HospitalGuiyang, GuizhouChinaRecruiting
Henan Provincial People's HospitalZhengzhou, HenanChinaRecruiting
Tongji Hospital,Tongji Medical College,Huazhong University of Science and TechnologyWuhan, HubeiChinaRecruiting
The Second Xiangya Hospital of Central South UniversityChangsha, HunanChinaRecruiting
Xiangya Hospital of Central South UniversityChangsha, HunanChinaRecruiting
Jiangsu Province HospitalNanjing, JiangsuChinaRecruiting
The Central Hospital of Shenyang MilitaryShenyang, LiaoningChinaRecruiting
The First Affiliated Hospital, China Medical UniversityShenyang, LiaoningChinaRecruiting
Xijing HospitalXi'an, ShaanxiChinaRecruiting
Qilu Hospital, Shandong UniversityJinan, ShandongChinaRecruiting
Shandong Provincal HospitalJinan, ShandongChinaRecruiting
Qingdao Municipal HospitalQingdao, ShandongChinaRecruiting
Weifang Asthma HospitalWeifang, ShandongChinaRecruiting
Yantai liuhuanding HospitalYantai, ShandongChinaRecruiting
Changhai Hospital, Second Military Medical UniversityShanghai, Shanghai MunicipalityChinaRecruiting
No.1 Hospital, Shanghai Jiaotong UniversityShanghai, Shanghai MunicipalityChinaRecruiting
Ruijin Hospital, Shanghai Jiaotong UniversityShanghai, Shanghai MunicipalityChinaRecruiting
Tongji Hospital, Tongji UniversityShanghai, Shanghai MunicipalityChinaRecruiting
Xinhua Hospital, Shanghai Jiaotong UniversityShanghai, Shanghai MunicipalityChinaRecruiting
Zhongshan Hospital, Fudan UniversityShanghai, Shanghai MunicipalityChinaRecruiting
West China Hospital,Sichuan UniversityChengdu, SichuanChinaRecruiting
Second Affiliated Hospital, School of Medicine, Zhejiang UniversityHangzhou, ZhejiangChinaRecruiting
Sir Run Run Shaw hospital, College of Medicine,Zhejiang UniversityHangzhou, ZhejiangChinaRecruiting
Huzhou Central HospitalHuzhou, ZhejiangChinaRecruiting
The Second Affiliated Hospital,Wenzhou Medical UniversityWenzhou, ZhejiangChinaRecruiting