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Completed

NCT Number: NCT03643263

Exhaled Breath Condensate Assessment in Stable Non-Cystic Fibrotic Bronchiectasis

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Shanghai Pulmonary Hospital , Tongji University

Shanghai, Shanghai Municipality, 200000, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

  • Willing to join in and sign the informed consent form.
  • 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.
  • 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.
  • 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:

  • All normal subjects had a negative history of allergy (negative skin prick tests to common allergens);
  • Normal lung function, and normal bronchial reactivity.
  • 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:

  • 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;
  • Serious comorbidities (chronic renal failure, hepatic disease, etc.) ;
  • Patients were on inhaled or oral mucolytics, or were receiving oxygen therapy or long-term oral antibiotics;
  • Poor compliance or cannot cooperate judged by doctors;
  • Participated in other clinical trials for nearly three months;

Treatment and study plan

Primary outcomes

  1. Exhaled breath condensate pH and the disease severity

    Time frame: One year

    The Relationship between pH of exhaled breath condensate and disease severity of Bronchiectasis

Secondary outcomes

  1. BSI scores

    Time frame: 30 days

    Assessment of the non-cystic fibrosis bronchiectasis severity according by the BSI score at the time of admission

  2. SGRQ scores

    Time frame: 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

  3. Lung function (FEV1 %, FVC %, FEV1/FVC %)

    Time frame: One year

    Lung function will be measured at the time of admission

  4. Sputum and peripheral blood inflammatory index (including IL-6, IL-8, IL-1β, TNF-a)

    Time frame: One year

    Sputum and peripheral blood inflammatory index will be assessed at the time of admission

  5. Sputum neutrophil cell

    Time frame: One year

    Sputum neutrophil cell count and percentage will be assessed at the time of admission

  6. Sputum bacteriological evaluation

    Time frame: One year

    Sputum bacteriological (pseudomonas aeruginosa and others) will be evaluated at the time of admission

  7. Blood gases parameters (PaO2, SaO2, PaCO2, pH)

    Time frame: 30 days

    Blood gases will be assessed at the time of admission

  8. Chest high-resolution computed tomography (CT)

    Time frame: One year

    Chest high-resolution computed tomography (CT) will be evaluated at the time of admission

  9. Frequency of acute exacerbation during one year

    Time frame: 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.

  10. Time to first exacerbation during the one-year follow up

    Time frame: 30 days

    The time to first exacerbation within one year after start of the study

  11. The number of hospitalizations for exacerbation

    Time frame: 30 days

    The number of hospitalizations for exacerbation within one year after start of the study

Sponsors and collaborators

Lead sponsor

Shanghai Pulmonary Hospital, Shanghai, China

Other

Registry information

Official study title

Exploring the Relationship Between pH of Exhaled Breath Condensate and Disease Severity as Well as Prognosis of Bronchiectasis

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Aug 22, 2018
Registry last updated
Jul 11, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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