Clinical Characteristics and Treatment of Chest Tightness Variant Asthma

Study Overview
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Brief Summary
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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.

Official Title
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Clinical Characteristics and Treatment of Chest Tightness Variant Asthma

Conditions
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Asthma, Chest Syndrome, Clinical Anxiety, Clinical Depression, Lung Function, Quality of Life, Eosinophilia, Nitric Oxide, Airway Responsiveness, Induced Sputum

Intervention / Treatment
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* Drug: Inhaled corticosteriod/long-acting beta-agonist plus Montelukast
* Drug: Inhaled corticosteriod/long-acting beta-agonist only


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ICS/LABA plus Montelukast<br> | Drug: Inhaled corticosteriod/long-acting beta-agonist plus Montelukast<br>* Inhaled corticosteriod/long-acting beta-agonist are regular inhaled drugs for classic asthma; Montelukast is benefitial for allergic disease<br>|
| Active Comparator: ICS/LABA only<br> | Drug: Inhaled corticosteriod/long-acting beta-agonist only<br>* Inhaled corticosteriod/long-acting beta-agonist are regular inhaled drugs for classic asthma<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Asthma control questionnaire (ACQ) | Scores of asthma control questionnaire (ACQ) | Change from baseline intervention therapy at 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Forced expiratory volume in one second | Value of forced expiratory volume in one second | Change from baseline intervention therapy at 3 months | 
| Airway responsiveness | Value of airway responsiveness | Change from baseline intervention therapy at 3 months | 
| Peak expiratory flow | Value of peak expiratory flow | Change from baseline intervention therapy at 3 months | 
| Asthma quality of life questionnaire | Scores of asthma quality of life questionnaire | Change from baseline intervention therapy at 3 months | 
| Acute asthma episode | Numbers of acute asthma episode | Change from baseline intervention therapy at 3 months | 
| Numbers of emergency or hospitalization | Numbers of emergency or hospitalization | Change from baseline intervention therapy at 3 months |