Exhaled Breath Condensate Assessment in Stable Non-Cystic Fibrotic Bronchiectasis

NCT03643263 | Completed

• 1 other identifier: 20180323
• Study Type: observational
• Target: 121
• Locations: 1 country
• Sites: 1

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.

Conditions

Bronchiectasis

Outcome Measures

Primary Outcomes (1)

• Exhaled breath condensate pH and the disease severity

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

  One year

Secondary Outcomes (11)

• BSI scores

  30 days

• SGRQ scores

  30 days

• Lung function (FEV1 %, FVC %, FEV1/FVC %)

  One year

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

  One year

• Sputum neutrophil cell

  One year

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The age of all subjects are older than 18 . The diagnosis of bronchiectasis need reference to the guideline published by BTS 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 exacerbation for at least 4 weeks before the study and had a negative history of allergy. None of patients had reversibility with inhaled salbutamol of 12% or more of predicted FEV1; All normal subjects had a negative history of allergy and normal lung function, they have no history of any lung disease (except for the history of pneumonia in the past time and small pulmonary nodules).

You may qualify if:

• 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).

You may not qualify if:

• 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;

Sponsors & Collaborators

• Shanghai Pulmonary Hospital, Shanghai, China: lead

Study Sites (1)

Shanghai Pulmonary Hospital , Tongji University

Shanghai, Shanghai Municipality, 200000, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

Collected exhaled breath condensate specimens for pH test

MeSH Terms

Conditions

Bronchiectasis

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases

Study Officials

• Jin-fu Xu, MD

  Shanghai Pulmonary Hospital, Shanghai, China

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Head of respiratory medicine

Study Record Dates

• First Submitted: August 21, 2018
• First Posted: August 22, 2018
• Study Start: June 25, 2018
• Primary Completion: July 2, 2020
• Study Completion: July 2, 2020
• Last Updated: July 11, 2022

Record last verified: 2022-07

Locations

CN (1)