Azithromycin Treatment for Non-eosinophilic Chest Tightness Variant Asthma

NCT05596721 | Unknown Phase 4 DMC

• 1 other identifier: AZNECTVA
• Study Type: interventional
• Target: 248
• Locations: 1 country
• Sites: 13

Brief 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.

Conditions

Asthma; Chest Syndrome; Azithromycin; Effect of Drug

Keywords

non-eosinophilic; chest tightness variant asthma; azithromycin; asthma control

Outcome Measures

Primary Outcomes (1)

• r-ACQ

  Revised-asthma control questionnaire.

  Change from Baseline ACQ at 12 weeks

Secondary Outcomes (7)

• FEV1

  Change from Baseline at 4 weeks, 8 weeks, and 12 weeks

• Airway responsiveness

  Change from Baseline at 4 weeks, 8 weeks, and 12 weeks

• PEF

  Change from Baseline at 4 weeks, 8 weeks, and 12 weeks

• AQLQ

  Change from Baseline at 4 weeks, 8 weeks, and 12 weeks

• SAS

  Change from Baseline at 4 weeks, 8 weeks, and 12 weeks

Study Arms (2)

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

Drug: Azithromycin; Drug: ICS/LABA

ICS/LABA

PLACEBO COMPARATOR

ICS/LABA: Budesonide and Formoterol Fum arate Powder for Inhalation, 1 inhale, bid for 12w

Drug: ICS/LABA

Interventions

Azithromycin DRUG

Treat patient with azithromycin for 12w.

Azithromycin + ICS/LABA

ICS/LABA DRUG

Treat patient with ICS/LABA according to Global Initiative for Asthma (GINA) guideline.

Azithromycin + ICS/LABA; ICS/LABA

Eligibility Criteria

• Age: 14 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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;
• obvious abnormal of High Resolution CT;
• macrolide allergy;
• received azithromycin treatment in the past 2 weeks;
• hearing impairment or abnormally prolonged QTc interval.

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (13)

China-Japan Friendship Hospital

Beijing, Beijing Municipality, China

Location

Xinqiao Hospital, Third Military Medical University

Chongqing, Chongqing Municipality, China

Location

The First Affiliated Hospital,Guangzhou Medical University

Guangzhou, Guangdong, China

Location

The Second Xiangya Hospital of Central South University

Changsha, Hunan, China

Location

Jiangsu Province Hospital

Nanjing, Jiangsu, China

Location

The Central Hospital of Shenyang Military

Shenyang, Liaoning, China

Location

Xijing Hospital

Xi'an, Shaanxi, China

Location

Qilu Hospital, Shandong University

Jinan, Shandong, China

Location

Changhai Hospital, Second Military Medical University

Shanghai, Shanghai Municipality, China

Location

Ruijin Hospital, Shanghai Jiaotong University

Shanghai, Shanghai Municipality, China

Location

Shanghai General Hospital

Shanghai, Shanghai Municipality, China

Location

Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, China

Location

The Second Affiliated Hospital, School of Medicine, Zhejiang University, China

Hanzhou, Zhejiang, China

Location

MeSH Terms

Conditions

Asthma

Interventions

Azithromycin

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Erythromycin; Macrolides; Polyketides; Lactones; Organic Chemicals

Study Officials

• Huahao Shen, M.D.

  The Second Affiliated Hospital, School of Medicine, Zhejiang University, China

  STUDY CHAIR

Central Study Contacts

Wen Hua, M.D.

CONTACT

+86 0571 87783552; hw1983@126.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2022
• First Posted: October 27, 2022
• Study Start: January 1, 2023
• Primary Completion: March 31, 2024
• Study Completion: March 31, 2024
• Last Updated: November 4, 2022

Record last verified: 2022-10

Locations

CN (13)