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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05596721
Other study ID # AZNECTVA
Secondary ID
Status Not yet recruiting
Phase Phase 4
First received
Last updated
Start date January 1, 2023
Est. completion date March 31, 2024

Study information

Verified date October 2022
Source Second Affiliated Hospital, School of Medicine, Zhejiang University
Contact Wen Hua, M.D.
Phone +86 0571 87783552
Email hw1983@126.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Bronchial asthma (abbr. asthma) is one of common airway chronic inflammatory disease which usually threatens human health. Typical symptoms of asthma are recurrent wheezing, shortness of breath, chest tightness and cough, usually happened at night or in early morning. However, there are still some patients who persist only clinical manifestations of chest tightness, namely, chest tightness variant asthma (CTVA). This subgroup of asthma usually lacks asthma-specific clinical features, therefore, often misdiagnosed and lack of effective treatment for a long time. The investigators' previous studies have found that CTVA has eosinophilic and non-eosinophilic subtypes. These patients with non-eosinophilic CTVA (NE-CTVA) are not sensitive to ICS/LABA, which guidelines recommend. At present, the specific treatment plan for NE-CTVA is urgently needed to elucidate. Azithromycin has immunomodulatory and anti-inflammatory effects in addition to their antibacterial effects. Maintenance treatment with azithromycin has been proved to be effective in chronic neutrophilic airway diseases and severe asthma. However, there are no clinical studies to confirm the effectiveness of azithromycin in non-eosinophilic asthma, especially atypical asthma such as NE-CTVA. Now the investigators performed a national multi-center study to explore whether azithromycin improves asthma symptom control and improves quality of life in people with NE-CTVA. Finally, to find an optimal treatment for NE-CTVA.


Description:

Bronchial asthma (abbr. asthma) is one of common airway chronic inflammatory disease which usually threatens human health. Typical symptoms of asthma are recurrent wheezing, shortness of breath, chest tightness and cough, usually happened at night or in early morning. However, there are still some patients who persist only clinical manifestations of chest tightness. Focus on this group of patients, the investigators proposed a subgroup of bronchial asthma, namely, chest tightness variant asthma (CTVA). This subgroup of asthma usually lacks asthma-specific clinical features such as wheezing, shortness of breath, wheezing, therefore, often misdiagnosed for a long time. The investigators' previous studies have found that CTVA is like the clinical classification of common asthma and cough variant asthma (CVA), and there are also eosinophilic and non-eosinophilic subtypes in CTVA. These patients with non-eosinophilic CTVA (NE-CTVA) are not sensitive to ICS/LABA, which guidelines recommend, and have lower FeNO values than sensitive CTVAs. At present, the specific treatment plan for NE-CTVA is a special clinical asthma phenotype, and further clinical studies are urgently needed to elucidate. Azithromycin has immunomodulatory and anti-inflammatory effects in addition to their antibacterial effects. Maintenance treatment with azithromycin has been proved to be effective in chronic neutrophilic airway diseases including chronic obstructive pulmonary disease, cystic fibrosis, bronchiectasis and diffuse panbronchiolitis. Whilst azithromycin is effective and recommended in current American Thoracic Society (ATS) / European Respiratory Society (ERS) and Global Initiative for Asthma (GINA) guidelines for selected persistently symptomatic adults with severe asthma. However, there are no clinical studies to confirm the effectiveness of azithromycin in non-eosinophilic asthma, especially atypical asthma such as NE-CTVA. The investigators conduct a national multi-center, prospective randomized trial to test the hypothesis that azithromycin improves symptom control and improves quality of life in people with NE-CTVA. To this end, the recruited participants will be randomly divided into ICS/LABA + azithromycin group and ICS/LABA group. The treatment period is 12 weeks, and then to evaluate the revised-asthma control questionnaire (r-ACQ) score, asthma quality of life questionnaire (AQLQ) score, self-rating anxiety scale (SAS), self-rating depression scale (SDS), lung function, and numbers of emergency or hospitalization. Provide clinical evidence for the optimal treatment of NE-CTVA.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 248
Est. completion date March 31, 2024
Est. primary completion date March 31, 2024
Accepts healthy volunteers No
Gender All
Age group 14 Years to 80 Years
Eligibility 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. blood eosinophils < 150/µl and FeNO < 20 ppb; 7. exclude the following diseases by the corresponding doctors: coronary heart disease, myocarditis, heart failure, 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 chronic hepatic kidney or neurologic disorder; 4. 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; 5. taking part in other drug clinical trial project, or drop out less than 3 months; 6. during pregnancy, lactation women; 7. obvious abnormal of High Resolution CT; 8. macrolide allergy; 9. received azithromycin treatment in the past 2 weeks; 10. hearing impairment or abnormally prolonged QTc interval.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Azithromycin
Treat patient with azithromycin for 12w.
ICS/LABA
Treat patient with ICS/LABA according to Global Initiative for Asthma (GINA) guideline.

Locations

Country Name City State
China China-Japan Friendship Hospital Beijing Beijing
China The Second Xiangya Hospital of Central South University Changsha Hunan
China Xinqiao Hospital, Third Military Medical University Chongqing Chongqing
China The First Affiliated Hospital,Guangzhou Medical University Guangzhou Guangdong
China The Second Affiliated Hospital, School of Medicine, Zhejiang University, China Hanzhou Zhejiang
China Qilu Hospital, Shandong University Jinan Shandong
China Jiangsu Province Hospital Nanjing Jiangsu
China Changhai Hospital, Second Military Medical University Shanghai Shanghai
China Ruijin Hospital, Shanghai Jiaotong University Shanghai Shanghai
China Shanghai General Hospital Shanghai Shanghai
China Zhongshan Hospital, Fudan University Shanghai Shanghai
China The Central Hospital of Shenyang Military Shenyang Liaoning
China Xijing Hospital Xi'an Shaanxi

Sponsors (1)

Lead Sponsor Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary r-ACQ Revised-asthma control questionnaire. Change from Baseline ACQ at 12 weeks
Secondary FEV1 Perform pulmonary function tests of patients and record the forced expiratory volume in one second. Change from Baseline at 4 weeks, 8 weeks, and 12 weeks
Secondary Airway responsiveness Perform pulmonary function tests of patients and record the PD20-FEV1. Change from Baseline at 4 weeks, 8 weeks, and 12 weeks
Secondary PEF Perform pulmonary function tests of patients and record the peak expiratory flow. Change from Baseline at 4 weeks, 8 weeks, and 12 weeks
Secondary AQLQ Asthma quality of life questionnaire. Change from Baseline at 4 weeks, 8 weeks, and 12 weeks
Secondary SAS Self-rating Anxiety Scale. Change from Baseline at 4 weeks, 8 weeks, and 12 weeks
Secondary SDS Self-rating Depression Scale. Change from Baseline at 4 weeks, 8 weeks, and 12 weeks
Secondary Numbers of emergency or hospitalization Record the numbers of emergency or hospitalization because asthma. Change from Baseline at 4 weeks, 8 weeks, and 12 weeks
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