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NCT Number: NCT03237221

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.

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Key information

Conditions

Asthma Airway Responsiveness Bronchial Diseases Chest Syndrome Clinical Anxiety Clinical Depression Depressive Disorder Depressive Disorder, Major Eosinophilia Hematologic Diseases Hemic and Lymphatic Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Induced Sputum Leukocyte Disorders Lung Diseases Lung Diseases, Obstructive Lung Function Mental Disorders Mood Disorders Nitric Oxide Quality of Life Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

14 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Beijing Chao-Yang Hospital, Beijing, Beijing Municipality, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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, 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.

Treatment and study plan

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

Drug

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

Primary outcomes

  1. Asthma control questionnaire (ACQ)

    Time frame: Change from Baseline ACQ score at 36 months

    Asthma control questionnaire (ACQ)

Secondary outcomes

  1. Forced expiratory volume in one second

    Time frame: Change from Baseline ACQ score at 36 months

    Forced expiratory volume in one second

  2. Airway responsiveness

    Time frame: Change from Baseline ACQ score at 36 months

    Airway responsiveness

  3. Peak expiratory flow

    Time frame: Change from Baseline ACQ score at 36 months

    Peak expiratory flow

  4. Asthma quality of life questionnaire

    Time frame: Change from Baseline ACQ score at 36 months

    Asthma quality of life questionnaire

  5. Acute asthma episode

    Time frame: Change from Baseline ACQ score at 36 months

    Acute asthma episode

  6. Numbers of emergency or hospitalization

    Time frame: Change from Baseline ACQ score at 36 months

    Numbers of emergency or hospitalization

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Other

Registry information

Important dates

Study start
2015
Primary completion
2019
Study completion
2020
First posted
Aug 2, 2017
Registry last updated
Oct 27, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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