Exhaled Breath Condensate Assessment in Stable Non-Cystic Fibrotic Bronchiectasis

Completed

• Conditions: Bronchiectasis

• Registration Number: NCT03643263
• Lead Sponsor: Shanghai Pulmonary Hospital, Shanghai, China

Brief Summary

The measurement of markers in the expired breath condensate has proven to be a useful method for assessing and monitoring airway inflammation. The aim of this study is to determine the amounts of pH in the expired breath condensate of patients with bronchiectasis, and the relationship between pH and the severity of bronchiectasis.

Detailed Description

The aim of this study is to determine the amounts of pH in the expired breath condensate of patients with bronchiectasis, and the relationship between pH and the severity of bronchiectasis. Further clarify the link between EBC pH and the risk of future acute exacerbations, mortality and lung function decline through a one-year follow-up. Hoping to explore new validated biomarkers of the disease severity and progression in bronchiectasis. During the observation, EBC pH and other valid indicators will be measured when patients were enrolled.

Study Timeline

• Study Start: 2018-06-25
• Study First Submitted: 2018-08-21
• Study First Submitted QC: 2018-08-21
• Study First Posted: 2018-08-22
• Primary Completion: 2020-07-02
• Study Completion: 2020-07-02
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-07
• Last Update Posted: 2022-07-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 121

Inclusion Criteria

Each subject must meet all of the following criteria to be included in this study:

1. Willing to join in and sign the informed consent form.
2. Age>18 years, the diagnosis of bronchiectasis need reference to the definition of "non-cystic fibrosis bronchiectasis guideline" published by British Thoracic Society in 2010 or 2012 China bronchiectasis expert consensus, clinical symptoms of cough and expectoration, with or without intermittent hemoptysis, and chest CT showed bronchiectasis there.
3. All patients were clinically stable and had no evidence of infection or acute infective exacerbation (lower or upper respiratory tract) for at least 4 weeks before the study.
4. Patients with good compliance: the subject must be willing to follow the test plan requirements in the research center to complete all the assessment of the visit.

Control Subjects:

1. All normal subjects had a negative history of allergy (negative skin prick tests to common allergens);
2. Normal lung function, and normal bronchial reactivity.
3. No history of any lung disease (except for the history of pneumonia in the past time and small pulmonary nodules).

Exclusion Criteria

Subjects who meet any of the following criteria should be excluded from this study:

1. Patients with a history of other respiratory diseases (cystic fibrosis, allergic bronchopulmonary aspergillosis, asthma, 1-antitrypsin deficiency, pulmonary tuberculosis, COPD, lung cancer, interstitial lung disease)and atopic diseases were excluded；
2. Serious comorbidities (chronic renal failure, hepatic disease, etc.) ;
3. Patients were on inhaled or oral mucolytics, or were receiving oxygen therapy or long-term oral antibiotics；
4. Poor compliance or cannot cooperate judged by doctors;
5. Participated in other clinical trials for nearly three months;

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Exhaled breath condensate pH and the disease severity	One year	The Relationship between pH of exhaled breath condensate and disease severity of Bronchiectasis

Secondary Outcome Measures

Name	Time	Method
Sputum bacteriological evaluation	One year	Sputum bacteriological (pseudomonas aeruginosa and others) will be evaluated at the time of admission
Blood gases parameters （PaO2, SaO2, PaCO2, pH）	30 days	Blood gases will be assessed at the time of admission
SGRQ scores	30 days	Assessment of the quality of life of non-cystic fibrosis bronchiectasis according by the St.George respiratory questionnaire at the time of admission
Time to first exacerbation during the one-year follow up	30 days	The time to first exacerbation within one year after start of the study
Frequency of acute exacerbation during one year	30 days	The number of acute exacerbation will be recorded by telephone follow-up monthly. The definition of acute exacerbation: if there are at least one symptoms (increased sputum volume or purulent sputum, increased dyspnea, increased cough, lung function decline, increased fatigue) or new symptoms (fever, pleurisy, hemoptysis, require antimicrobial therapy), then prompted acute exacerbation.
The number of hospitalizations for exacerbation	30 days	The number of hospitalizations for exacerbation within one year after start of the study
BSI scores	30 days	Assessment of the non-cystic fibrosis bronchiectasis severity according by the BSI score at the time of admission
Lung function (FEV1 %, FVC %, FEV1/FVC %)	One year	Lung function will be measured at the time of admission
Chest high-resolution computed tomography (CT)	One year	Chest high-resolution computed tomography (CT) will be evaluated at the time of admission
Sputum and peripheral blood inflammatory index (including IL-6, IL-8, IL-1β, TNF-a)	One year	Sputum and peripheral blood inflammatory index will be assessed at the time of admission
Sputum neutrophil cell	One year	Sputum neutrophil cell count and percentage will be assessed at the time of admission

Trial Locations

Locations (1)

Shanghai Pulmonary Hospital , Tongji University; 🇨🇳 Shanghai, Shanghai, China