Clinical Characteristics and Treatment of Chest Tightness Variant Asthma
NCT04322422 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 300
Last updated 2020-05-12
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.
Conditions
- Asthma
- Chest Syndrome
- Clinical Anxiety
- Clinical Depression
- Lung Function
- Quality of Life
- Eosinophilia
- Nitric Oxide
- Airway Responsiveness
- Induced Sputum
Interventions
- DRUG
-
Inhaled corticosteriod/long-acting beta-agonist plus Montelukast
Inhaled corticosteriod/long-acting beta-agonist are regular inhaled drugs for classic asthma; Montelukast is benefitial for allergic disease
- DRUG
-
Inhaled corticosteriod/long-acting beta-agonist only
Inhaled corticosteriod/long-acting beta-agonist are regular inhaled drugs for classic asthma
Sponsors & Collaborators
-
Second Affiliated Hospital, School of Medicine, Zhejiang University
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 14 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-06-01
- Primary Completion
- 2022-07-01
- Completion
- 2022-12-31
Countries
- China
Study Locations
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