Exhaled Breath Condensate Assessment in Stable Non-Cystic Fibrotic Bronchiectasis

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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