Exhaled Breath Condensate Assessment in Stable Non-Cystic Fibrotic Bronchiectasis

NCT ID: NCT03643263

Last Updated: 2022-07-11

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 121 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-06-25
• Study Completion Date: 2020-07-02

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.

Conditions

Bronchiectasis

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

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

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;

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Shanghai Pulmonary Hospital, Shanghai, China

OTHER

Sponsor Role: lead

Responsible Party

Jin-Fu Xu

Director, Head of respiratory medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jin-fu Xu, MD

Role: PRINCIPAL_INVESTIGATOR

Shanghai Pulmonary Hospital, Shanghai, China

Locations

Shanghai Pulmonary Hospital , Tongji University

Shanghai, Shanghai Municipality, China

Countries

China

Other Identifiers

20180323

Identifier Type: -

Identifier Source: org_study_id