AsthmaPhase 4NCT05596721
Azithromycin Treatment for Non-eosinophilic Chest Tightness Variant Asthma
A Phase 4 study testing Azithromycin and ICS/LABA in people with Asthma and Chest Syndrome, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 13 sites in China.
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. Read more about this study
- Who is it for?
- Ages 14 to 80 years
- Conditions the study is for
- Asthma, Chest Syndrome, Azithromycin
- What is being tested?
- Azithromycin and ICS/LABA
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 248 participants
- Where
- 13 sitesChina
- Study dates
- 1 Jan 2023to 31 Mar 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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;
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- 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.
- blood eosinophils < 150/µl and FeNO < 20 ppb;
- exclude the following diseases by the corresponding doctors: coronary heart disease, myocarditis, heart failure, GERD, neuromuscular disease, and mental disease.
Who cannot join
- 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 chronic hepatic kidney or neurologic disorder;
- 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;
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- obvious abnormal of High Resolution CT;
- macrolide allergy;
- received azithromycin treatment in the past 2 weeks;
- hearing impairment or abnormally prolonged QTc interval.
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
China13 sites
China-Japan Friendship Hospital
Beijing, Beijing Municipality
Nan Su, M.D.
The Second Xiangya Hospital of Central South University
Changsha, Hunan
Xudong Xiang, M.D.
Xinqiao Hospital, Third Military Medical University
Chongqing, Chongqing Municipality
Changzheng Wang, M.D.
The First Affiliated Hospital,Guangzhou Medical University
Guangzhou, Guangdong
Nanshan Zhong, M.D.
The Second Affiliated Hospital, School of Medicine, Zhejiang University, China
Hanzhou, Zhejiang
Wen Hua, M.D.
Qilu Hospital, Shandong University
Jinan, Shandong
Jiangsu Province Hospital
Nanjing, Jiangsu
Mao Huang, M.D.
Changhai Hospital, Second Military Medical University
Shanghai, Shanghai Municipality
Yan Shang, M.D.
Ruijin Hospital, Shanghai Jiaotong University
Shanghai, Shanghai Municipality
Huanying Wan, M.D.
Shanghai General Hospital
Shanghai, Shanghai Municipality
Xin Zhou, M.D.
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality
The Central Hospital of Shenyang Military
Shenyang, Liaoning
Hua Xie, M.D.
Xijing Hospital
Xi'an, Shaanxi
Changgui Wu, M.D.
About this study
Official title: Effect of Azithromycin With ICS/LABA in Non-eosinophilic Chest Tightness Variant Asthma: a Multicentre Randomized Trial
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.
Read the detailed 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.
- Conditions
- Asthma, Chest Syndrome, Azithromycin, Effect of Drug
- Being tested
- Azithromycin, ICS/LABA
- Keywords
- non-eosinophilic, chest tightness variant asthma, azithromycin, asthma control
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AzithromycinDrug
Treat patient with azithromycin for 12w.
ICS/LABADrug
Treat patient with ICS/LABA according to Global Initiative for Asthma (GINA) guideline.
| Study group | Role | What they receive |
|---|---|---|
| Azithromycin + ICS/LABA | Experimental | Azithromycin: 500mg, po, 3 times per week for 12w ICS/LABA: Budesonide and Formoterol Fum arate Powder for Inhalation, 1 inhale, bid for 12w Receives: Drug: Azithromycin; Drug: ICS/LABA |
| ICS/LABA | Placebo comparator | ICS/LABA: Budesonide and Formoterol Fum arate Powder for Inhalation, 1 inhale, bid for 12w Receives: Drug: ICS/LABA |
What is being measured
The primary outcome is the main question the study is designed to answer.
r-ACQ
Revised-asthma control questionnaire.
Measured: Change from Baseline ACQ at 12 weeks
Secondary outcomes (7)
FEV1
Perform pulmonary function tests of patients and record the forced expiratory volume in one second.
Measured: Change from Baseline at 4 weeks, 8 weeks, and 12 weeks
Airway responsiveness
Perform pulmonary function tests of patients and record the PD20-FEV1.
Measured: Change from Baseline at 4 weeks, 8 weeks, and 12 weeks
PEF
Perform pulmonary function tests of patients and record the peak expiratory flow.
Measured: Change from Baseline at 4 weeks, 8 weeks, and 12 weeks
AQLQ
Asthma quality of life questionnaire.
Measured: Change from Baseline at 4 weeks, 8 weeks, and 12 weeks
SAS
Self-rating Anxiety Scale.
Measured: Change from Baseline at 4 weeks, 8 weeks, and 12 weeks
SDS
Self-rating Depression Scale.
Measured: 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.
Measured: Change from Baseline at 4 weeks, 8 weeks, and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2022
- Study start1 Jan 2023 (estimated)
- Primary completion31 Mar 2024 (estimated)
- Study completion31 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 248 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Huahao Shen, M.D., Study chair, The Second Affiliated Hospital, School of Medicine, Zhejiang University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05596721
- Sponsor's protocol ID
- AZNECTVA
- Status last verified
- Oct 2022
- First submitted
- 25 Oct 2022
- Last updated
- 4 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Azithromycin With ICS/LABA in Non-eosinophilic Chest Tightness Variant Asthma: a Multicentre Randomized Trial
- ClinicalTrials.gov ID
- NCT05596721
- Acronym / sponsor ID
- AZNECTVA
- Conditions
- Asthma, Chest Syndrome, Azithromycin, Effect of Drug
- Keywords
- non-eosinophilic, chest tightness variant asthma, azithromycin, asthma control
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 248 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 Jan 2023 (estimated)
- Primary completion
- 31 Mar 2024 (estimated)
- Study completion
- 31 Mar 2024 (estimated)
- First posted
- 27 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Azithromycin + ICS/LABA | Experimental | Drug: Azithromycin, Drug: ICS/LABAAzithromycin: 500mg, po, 3 times per week for 12w ICS/LABA: Budesonide and Formoterol Fum arate Powder for Inhalation, 1 inhale, bid for 12w |
| ICS/LABA | Placebo comparator | Drug: ICS/LABAICS/LABA: Budesonide and Formoterol Fum arate Powder for Inhalation, 1 inhale, bid for 12w |
Who may qualify
- Ages
- 14 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- 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:
Key exclusion criteria (10 listed)
- 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 chronic hepatic kidney or neurologic disorder;
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AzithromycinTreat patient with azithromycin for 12w. | Drug | Azithromycin + ICS/LABA |
| ICS/LABATreat patient with ICS/LABA according to Global Initiative for Asthma (GINA) guideline. | Drug | Azithromycin + ICS/LABA, ICS/LABA |
Primary outcome
r-ACQ
Time frame: Change from Baseline ACQ at 12 weeks
Revised-asthma control questionnaire.
7 secondary outcomes
FEV1
Time frame: Change from Baseline at 4 weeks, 8 weeks, and 12 weeks
Airway responsiveness
Time frame: Change from Baseline at 4 weeks, 8 weeks, and 12 weeks
PEF
Time frame: Change from Baseline at 4 weeks, 8 weeks, and 12 weeks
AQLQ
Time frame: Change from Baseline at 4 weeks, 8 weeks, and 12 weeks
SAS
Time frame: Change from Baseline at 4 weeks, 8 weeks, and 12 weeks
SDS
Time frame: Change from Baseline at 4 weeks, 8 weeks, and 12 weeks
Numbers of emergency or hospitalization
Time frame: Change from Baseline at 4 weeks, 8 weeks, and 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Huahao Shen, M.D. study chair
The Second Affiliated Hospital, School of Medicine, Zhejiang University, China
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Azithromycin and ICS/LABA in people with Asthma and Chest Syndrome, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 13 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wen Hua, M.D. (+86 0571 87783552, hw1983@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
r-ACQ (time frame: Change from Baseline ACQ at 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2022.