Brief Title
Exhaled Breath Condensate Assessment in Stable Non-Cystic Fibrotic Bronchiectasis
Official Title
Exploring the Relationship Between pH of Exhaled Breath Condensate and Disease Severity as Well as Prognosis of Bronchiectasis
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. In the subgroup study, these indicators were tested repeatedly in exacerbation
start, exacerbation recovery (after 14 days of antibiotic therapy), stable2 (at the second
stable measurement 6 months later). To determine whether it could be used as an "signal
searching" or "early efficacy" end-point for new antibiotics or anti-inflammatory therapies
Study Type
Observational
Primary Outcome
Exhaled breath condensate pH and the disease severity
Secondary Outcome
BSI scores
Condition
Bronchiectasis
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Estimated Enrollment
121
Start Date
June 25, 2018
Completion Date
July 2, 2020
Primary Completion Date
July 2, 2020
Eligibility Criteria
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. All subjects had a negative history of allergy (negative skin prick tests to common
aeroallergens). None of our patients had reversibility with inhaled salbutamol of 12%
or more of predicted FEV1.
5. 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. None of the patients were on inhaled or oral mucolytics, and none 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;
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Contacts
Jin-fu Xu, MD, ,
Location Countries
China
Location Countries
China
Administrative Informations
NCT ID
NCT03643263
Organization ID
20180323
Responsible Party
Principal Investigator
Study Sponsor
Shanghai Pulmonary Hospital, Shanghai, China
Study Sponsor
Jin-fu Xu, MD, Principal Investigator, Shanghai Pulmonary Hospital, Shanghai, China
Verification Date
August 2020