AzTrials
AzTrials

BronchiectasisNCT03643263

Exhaled Breath Condensate Assessment in Stable Non-Cystic Fibrotic Bronchiectasis

An observational study of Bronchiectasis, run by Shanghai Pulmonary Hospital, Shanghai, China at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Bronchiectasis
How many people
121 participants
Where
1 siteChina
Study dates
25 Jun 2018to 2 Jul 2020
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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).

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. 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. 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;

Trial locations and contacts

1 site in 1 country.

China1 site

  • Shanghai Pulmonary Hospital , Tongji University

    Shanghai, Shanghai Municipality, 200000

Other trials in China

About this study

Official title: Exploring the Relationship Between pH of Exhaled Breath Condensate and Disease Severity as Well as Prognosis of 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.

Read the 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
Medical subject headings
Bronchiectasis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Exhaled breath condensate pH and the disease severity

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

    Measured: One year

Secondary outcomes (11)

  1. BSI scores

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

    Measured: 30 days

  2. SGRQ scores

    Assessment of the quality of life of non-cystic fibrosis bronchiectasis according by the St.George respiratory questionnaire at the time of admission

    Measured: 30 days

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

    Lung function will be measured at the time of admission

    Measured: One year

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

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

    Measured: One year

  5. Sputum neutrophil cell

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

    Measured: One year

  6. Sputum bacteriological evaluation

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

    Measured: One year

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

    Blood gases will be assessed at the time of admission

    Measured: 30 days

  8. Chest high-resolution computed tomography (CT)

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

    Measured: One year

  9. Frequency of acute exacerbation during one year

    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.

    Measured: 30 days

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

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

    Measured: 30 days

  11. The number of hospitalizations for exacerbation

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

    Measured: 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Aug 2018
  2. Study start25 Jun 2018
  3. Primary completion2 Jul 2020
  4. Study completion2 Jul 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
121 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03643263
Sponsor's protocol ID
20180323
Status last verified
Jul 2022
First submitted
21 Aug 2018
Last updated
11 Jul 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Bronchiectasis, run by Shanghai Pulmonary Hospital, Shanghai, China at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Exhaled breath condensate pH and the disease severity (time frame: One year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03643263.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2022.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in