A Phase 4 interventional study of Azithromycin and ICS/LABA in Asthma, Chest Syndrome and Azithromycin, sponsored by Second Affiliated Hospital, Zhejiang University, School of Medicine. Status unknown at 13 sites in China. Open to participants aged 14 Years to 80 Years. Per ClinicalTrials.gov, last updated 2022-11-04.
Sponsored by Second Affiliated Hospital, Zhejiang University, School of Medicine · Phase 4, Interventional, and Treatment
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.
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.
4,010 studies on the registry are indexed under Asthma; 514 are open to participants now.
This study's planned enrollment of 248 is above the median of 83 across 2,814 interventional studies indexed under Asthma.
Browse Asthma studies →Second Affiliated Hospital, Zhejiang University, School of Medicine is the lead sponsor of 90 studies on the registry; 60 are open to participants now.
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a diagnosis of asthma supported by one or more other characteristics:
Exclusion Criteria:
Azithromycin: 500mg, po, 3 times per week for 12w ICS/LABA: Budesonide and Formoterol Fum arate Powder for Inhalation, 1 inhale, bid for 12w
Drug: Azithromycin · Drug: ICS/LABA
ICS/LABA: Budesonide and Formoterol Fum arate Powder for Inhalation, 1 inhale, bid for 12w
Drug: ICS/LABA
Treat patient with azithromycin for 12w.
Treat patient with ICS/LABA according to Global Initiative for Asthma (GINA) guideline.
r-ACQ
Revised-asthma control questionnaire.
Time frame: Change from Baseline ACQ at 12 weeks
FEV1
Perform pulmonary function tests of patients and record the forced expiratory volume in one second.
Time frame: Change from Baseline at 4 weeks, 8 weeks, and 12 weeks
Airway responsiveness
Perform pulmonary function tests of patients and record the PD20-FEV1.
Time frame: Change from Baseline at 4 weeks, 8 weeks, and 12 weeks
PEF
Perform pulmonary function tests of patients and record the peak expiratory flow.
Time frame: Change from Baseline at 4 weeks, 8 weeks, and 12 weeks
AQLQ
Asthma quality of life questionnaire.
Time frame: Change from Baseline at 4 weeks, 8 weeks, and 12 weeks
SAS
Self-rating Anxiety Scale.
Time frame: Change from Baseline at 4 weeks, 8 weeks, and 12 weeks
SDS
Self-rating Depression Scale.
Time frame: Change from Baseline at 4 weeks, 8 weeks, and 12 weeks
Numbers of emergency or hospitalization
Record the numbers of emergency or hospitalization because asthma.
Time frame: Change from Baseline at 4 weeks, 8 weeks, and 12 weeks
This study is status unknown, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Azithromycin
Second Affiliated Hospital, Zhejiang University, School of Medicine