THERMotherapy Against Persistent Bacterial LUNG Infections
NCT05351242
Asthma, Bronchial Diseases
Hellerup, Capital Region, Denmark
View Trial DetailsNCT Number: NCT06938022
This study,Respiratory microbiota, infection characteristics and imaging manifestations in patients with chronic airway inflammation, adopted a prospective, observational, multi-omics study design to comprehensively evaluate the effects of respiratory microbiota, infection characteristics and imaging manifestations on disease outcomes and quality of life in patients with chronic airway inflammation. Involving six parallel sub-studies, These include: (1) the differences and mechanisms of lung microecology in ICS treatment sensitivity and resistance in patients with chronic airway inflammation, (2) the study of respiratory viral infection and inflammatory markers in patients with acute exacerbation of chronic obstructive pulmonary disease, (3) the effect of respiratory viral infection on the airway inflammation and disease severity of asthma in acute exacerbation, (4) the clinical significance of fungal infection in acute exacerbation of bronchiectasis, (5) the role of pulmonary function test and chest CT in predicting acute exacerbation of chronic obstructive pulmonary disease, and (6) the predictive value of baseline pulmonary function and radiomics in acute exacerbation of bronchiectasis, Each sub-study targeted a different study purpose and a specific patient population. All sub-studies followed uniform research principles, including scientificity, ethics, and consistency. All subjects were required to sign an informed consent form before enrollment to ensure that they understood the purpose, process, possible risks and privacy protection measures of the study. The study plans to enroll about 1,000 eligible patients covering chronic airway inflammatory diseases such as asthma, chronic obstructive pulmonary disease (COPD) and bronchiectasis.
In this study, multi-omics techniques, including microbiome, metabolomics, radiomics, and transcriptomics, were used to comprehensively evaluate the effects of respiratory microbiota, infection characteristics, and imaging manifestations on disease outcomes and quality of life in patients with chronic airway inflammation.
Trial opening soon.
Get Notified18 year–80 year
All sexes
Observational
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
(1) Age: 18 to 80 years old (inclusive), without restrictions on gender or ethnicity.
(2) Disease Diagnosis:
(3) Disease Status:
(4) Treatment Status:
(5) Others:
Exclusion criteria
(1) Recent Medication Use:
(2) Other Significant Diseases:
(3) Disease Status:
[1] Patients who have experienced any degree of acute exacerbation within the last 4 weeks before screening for the stable phase study.
(4) Special Populations:
[1] Patients with contraindications to pulmonary function tests and chest CT, such as chest metal, history of myocardial infarction, stroke, aortic aneurysm, or ocular surgery or retinal detachment within the last 3 months.
Time frame: Baseline, Week 4 (mid-intervention), and Week 8 (end of intervention) follow-up.
Multiplex RT-qPCR analysis was performed to analyze the microbial species and abundance of respiratory tract microorganisms in sputum samples, nasopharyngeal swabs or exhaled air condensate of patients with chronic airway inflammation
Time frame: Baseline, Week 4 , Week 8 , and 3-month follow-up.
In the research group of ICS treatment sensitivity and resistance in Chronic Airway Inflammation, Asthma symptom control will be assessed using the Asthma Control Test (ACT), a validated questionnaire with scores ranging from 5 to 25. Higher scores indicate better asthma control.
Time frame: Baseline, Week 4 , Week 8 , and 3-month follow-up.
In the research group of ICS treatment sensitivity and resistance in Chronic Airway Inflammation, Chronic Obstructive Pulmonary Disease Assessment Test(CAT) is a tool used to assess the severity of chronic obstructive pulmonary disease (COPD) and the quality of life of patients. The scoring range is 0 - 10 points. Grade division: 0 - 2 points: Mild. 3 - 5 points: Moderate. 6 - 10 points: Severe.
Time frame: Baseline, Week 4, Week 8 follow-up.
Detection of airway inflammatory factors by ELISA, such as IL-4, IL-5, IL-6, IL-8, IL-13, IL-33, TNF-α, IL-1β, etc.The concentration of Airway Inflammation Markers is measured in pg/mL.
Time frame: Baseline, Week 4 , Week 8 , and 3-month follow-up.
Pulmonary function FEV1 index was evaluated in liters (L). It refers to the volume of air exhaled in the first second by the subject exhaling at the fastest rate after the maximum inspiration.
Time frame: Baseline, Week 4 , Week 8 , and 3-month follow-up.
PEF is measured in liters per minute (L/min). It refers to the maximum flow rate that can be achieved when exhaling at the fastest speed after the maximum inspiration. This indicator can reflect how open the airway is.
Time frame: Baseline, Week 4 , Week 8 , and 3-month follow-up.
MMEF75/25 is measured in liters per minute (L/min). This is the average expiratory flow rate over the course of 75% to 25% of the forced expiratory volume. It is primarily used to assess the function of the small airways.
Time frame: Baseline, Week 4 , Week 8 , and 3-month follow-up.
FVC is measured in liters (L). It is the maximum volume of air that can be exhaled by exhaling forcefully as fast as possible after the maximum inhalation. This indicator reflects the ventilatory function of the lungs. FVC is generally around 3.5 - 5 L in normal adult males and slightly lower in females. FVC can be used to assess the elasticity of the lungs, the patency of the airways, etc.
Time frame: Baseline, Week 4 , Week 8 , and 3-month follow-up.
The unit of FEV1/FVC is %. It is mainly used to determine if there is an airflow obstruction. Normally, FEV1/FVC should be greater than 70%.
Time frame: Baseline, Week 4 , Week 8 follow-up.
Including CRP, WBC, Neu, Mono, Eos, RBC, Hb, and PLT.
Time frame: Baseline, Week 4 , Week 8 follow-up.
The serum viral antibody titer is measured by ELISA, which is a commonly used method for detecting and quantifying antibodies in patient samples. Then, these results will be used to analyze the relationship between viral infection and disease status, severity, or treatment response.
Time frame: Baseline, Week 4 , Week 8 , and 3-month follow-up.
Anxiety symptoms will be assessed using the Hamilton Anxiety Rating Scale (HAMA), a validated scale with scores ranging from 0 to 56, where higher scores indicate greater anxiety severity.
Time frame: Baseline, Week 4 , Week 8 , and 3-month follow-up.
Depressive symptoms will be observed using the Hamilton Depression Rating Scale (HAMD), which scores from 0 to 52, with higher scores indicating more severe depression.
Time frame: Baseline, Week 4, Week 8,3-month,6-month,9-month,and 12-month follow-up.
The safety will be assessed by monitoring and recording the incidence of treatment-emergent serious adverse events (SAEs) using the Serious Adverse Event Report Form (SAE Report). The research team will document, analyze, and provide appropriate medical responses to any incidents.
Time frame: Baseline, Week 4, Week 8,3-month,6-month,9-month,and 12-month follow-up.
Record the number of emergency visits and hospitalizations to evaluate the clinical effectiveness of treatment.
Time frame: Baseline, Week 4, Week 8,3-month,6-month,9-month,and 12-month follow-up.
The unit of Number of Acute Exacerbations is number of events. Total count of acute exacerbations experienced by participants.
Time frame: Baseline, Week 4, Week 8,3-month,6-month,9-month,and 12-month follow-up.
Acute exacerbation events of the disease will be assessed using Asthma, COPD, Bronchiectasis exacerbation records, recording the timing, frequency, and severity of each exacerbation. and grade the severity as mild, moderate, or severe.
Time frame: Baseline, Week 4, Week 8,3-month,6-month,9-month,and 12-month follow-up.
The number of emergency department visits due to acute exacerbations of Asthma, Chronic Obstructive Pulmonary Disease (COPD), and Bronchiectasis will be tracked using patients' self-reports and verified through medical records. This measure helps to evaluate the severity of the diseases.
Time frame: Baseline, Week 4, Week 8,3-month,6-month,9-month,and 12-month follow-up.
The number of people hospitalized due to acute exacerbations of Asthma, COPD (Chronic Obstructive Pulmonary Disease), and Bronchiectasis will be recorded, including detailed information such as the length of hospital stay and the treatments administered.
Time frame: Baseline, Week 4, Week 8, 3-month, 6-month, 9-month, and 12-month follow-up.
The unit of Severity Grading of Acute Exacerbations is units on a severity scale. Severity of each acute exacerbation categorized by a standardized scale (e.g., mild/moderate/severe or graded numerically, such as Grade 1-3).
Time frame: Baseline, Week 4, Week 8,3-month,6-month,9-month,and 12-month follow-up.
Documentation of respiratory failure events during hospital stays, including clinical criteria for diagnosis and management details.
Time frame: Baseline, Week 4, Week 8, 3-month, 6-month, 9-month, and 12-month follow-up.
The unit of Number of Moderate to Severe Acute Exacerbations is number of events. Count of exacerbations classified as moderate or severe based on the severity grading scale.
Time frame: Baseline, Week 4, Week 8,3-month,6-month,9-month,and 12-month follow-up.
Documentation of the use of non-invasive ventilation during hospitalization, including indications and duration of use.
Time frame: Baseline, Week 4, Week 8,3-month,6-month,9-month,and 12-month follow-up.
Records of ICU admissions and whether intubation was required during hospitalization, including associated clinical details.
Time frame: Baseline, Week 4, Week 8,3-month,6-month,9-month,and 12-month follow-up.
Documentation of systemic corticosteroid use during hospital stays, including dosage and duration.
Time frame: Baseline, Week 4, Week 8,3-month,6-month,9-month,and 12-month follow-up.
Total duration of each hospital stay will be recorded to assess the impact of the intervention on hospitalization length.
Time frame: Baseline, Week 4 , Week 8 , and 3-month follow-up.
It is used to evaluate the quality of life of COPD patients in groups other than the chronic airway inflammation ICS research group. It includes 8 items, involving dyspnea, exercise ability, cough, sputum, chest tightness, sleep quality, self - confidence and energy level. The scoring range is 0 - 10 points.
Grade division:
0 - 2 points: Mild. 3 - 5 points: Moderate. 6 - 10 points: Severe.
Time frame: Baseline, Week 4 , Week 8 , and 3-month follow-up.
The SGRQ is used to evaluate the quality of life of patients with chronic respiratory diseases. It consists of three parts: symptoms, activities, and impact on daily life. The scoring range is 0 - 100 points. The higher the total score, the poorer the patient's quality of life.
Time frame: Baseline, Week 4 , Week 8 , and 3-month follow-up.
The mMRC Score is used to assess the severity of dyspnoea and is divided into grades 0 - 4. The higher the score, the more severe the dyspnoea.
Grade 0: Dyspnoea occurs only during strenuous exercise. Grade 1: Dyspnoea occurs when walking fast on flat ground or climbing a gentle slope.
Grade 2: Dyspnoea causes the patient to stop and rest when walking on flat ground.
Grade 3: Dyspnoea causes the patient to stop and rest after walking less than 100 metres or for a few minutes on flat ground.
Grade 4: The patient is unable to leave home due to dyspnoea, or dyspnoea occurs when dressing or undressing.
Time frame: Baseline, Week 4 , Week 8 , and 3-month follow-up.
The ACT Score is used to evaluate the quality of life of asthma patients in groups other than the chronic airway inflammation ICS research group. The scoring range is 5 - 25 points.
Grade division:
20 - 25 points: Asthma is well - controlled. 16 - 19 points: Asthma is partially - controlled. Less than 16 points: Asthma is uncontrolled.
Time frame: Baseline, Week 4 , Week 8 , and 3-month follow-up.
The Asthma Quality of Life Questionnaire is used to evaluate the quality of life of asthma patients. The scoring range is 1 - 7 points. The higher the score, the better the quality of life.
Time frame: Baseline, Week 4 , Week 8 , and 3-month follow-up.
FACED Score includes Forced Expiratory Volume in 1 second (FEV1)、Age、Chronic colonization by Pseudomonas aeruginosa (PA)、Extension (number of pulmonary lobes affected)、Dyspnea (mMRC score).It is used to assess the severity of bronchiectasis. The scoring range is from 0 to 10 points.
Grade classification:
0 - 2 points: Mild. 3 - 5 points: Moderate. 6 - 10 points: Severe.
Time frame: Baseline, Week 4 , Week 8 , and 3-month follow-up.
The BEST Score is used to assess the symptoms of dyspnea and cough. The scoring range is from 0 to 10 points.
Grade classification:
0 - 2 points: Mild. 3 - 5 points: Moderate. 6 - 10 points: Severe.
Contact information is provided by the study sponsor or research team.
Chao Cao
CONTACT
Shiyi He
CONTACT
First Affiliated Hospital of Ningbo University
Network
Chronic Airway Inflammation: The Impact of Respiratory Microbiota, Infection Characteristics, and Imaging Features on Disease Progression and Quality of Life-A Multomic and Comprehensive Study
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