Clinical Characteristics and Treatment of Chest Tightness Variant Asthma

  • STATUS
    Recruiting
  • End date
    Dec 31, 2022
  • participants needed
    300
  • sponsor
    Second Affiliated Hospital, School of Medicine, Zhejiang University
Updated on 25 January 2021
corticosteroids
COPD
montelukast
pulmonary disease
cough
wheezing
airways disease
bronchodilator
forced expiratory volume
albuterol
chest tightness
peak expiratory flow

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.

Details
Condition Eosinophilia, White blood cell disorder, White Cell Disorders, Respiratory physiology, Pulmonary Function Test, Nitric Oxide, Quality of life, Asthma, Asthma, Asthma (Pediatric), Allergies & Asthma, Allergies & Asthma, White Cell Disorders, Asthma (Pediatric), Chest Syndrome, Clinical Anxiety, Clinical Depression, Airway Responsiveness, Induced Sputum, asthmatic, bronchial asthma, eosinophilic disorders, pulmonary function tests, lung function, lung function tests, quality-of-life
Treatment Inhaled corticosteriod/long-acting beta-agonist plus Montelukast, Inhaled corticosteriod/long-acting beta-agonist only
Clinical Study IdentifierNCT04322422
SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University
Last Modified on25 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

all subjects agreed to participate, understand the project, observe the use of drugs, agree to follow-up, and signed informed consent
the age of more than 14 and less 80 years old, gender and ethnicity are not limited
the duration time was more than 6 months,and chest tightness was the only complaint, without breathing, short of breath, chronic cough
no wheezing
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
bronchodilator and glucocorticoid treatment is effective
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

can not cooperate with related inspection or for other reasons
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)
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
taking part in other drug clinical trial project, or drop out less than 3 months
during pregnancy, lactation women
obvious abnormal of High Resolution CT
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