Cystic Fibrosis, Pulmonary Clinical Trial
Official title:
The Clinical and Genetic Characteristics of Cystic Fibrosis and Cystic Fibrosis Disorders in Chinese Adults With Bronchiectasis
The study carries out Sweet Tests and CFTR-mutation screening to explore the prevalence, clinical characteristics, and prognosis of cystic fibrosis, as well as the CFTR-mutation spectrum in Chinese adults with bronchiectasis. The study is multi-centered, prospective, non-interventional, and observational.
Status | Recruiting |
Enrollment | 1000 |
Est. completion date | December 31, 2024 |
Est. primary completion date | December 31, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Age>18 years, the diagnosis of bronchiectasis needs a reference to the definition of "non-cystic fibrosis bronchiectasis guideline" published by the British Thoracic Society in 2017 or 2021 China bronchiectasis expert consensus, clinical symptoms of cough and expectoration, with or without intermittent hemoptysis, and chest CT showed bronchiectasis - Patients who are willing to sign the consent form and participate in the study. Exclusion Criteria: - Patients with incomplete essential information, which is needed for the integrity of data analysis. Essential information includes CT images, respiratory sample cultures, spirometry, and exacerbation history for at least one year. - Patients under 18 years old. Sweat Test Exclusion Criteria: - Patients with an implanted device, such as a defibrillator, neurostimulator, pacemaker, or ECG monitor. - Patients with a history of epilepsy or seizures. - Patients who are pregnant. - Patients that have a known sensitivity or allergy to any ingredient. - Over-damaged, denuded skin or other recent scar tissue. - Patients with Cardiac Conditions or with suspected heart problems. |
Country | Name | City | State |
---|---|---|---|
China | Shanghai pulmonary hospital | Shanghai | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Shanghai Pulmonary Hospital, Shanghai, China |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Prevelance of CF or CFTR dysfunction | The CF and CFTR dysfunction diagnosis is according to the results of sweat tests combined with CFTR sequencing results. CF is defined as a chloride concentration above 59 mmol/L combined with more than one CFTR mutation, while CFTR dysfunction is defined as a chloride concentration between 30-59mmol/L combined with one or two CFTR mutations. | 1 year | |
Other | Microbiology | Sputum or bronchoalveolar lavage fluid culture | through study completion, an average of 1 year | |
Other | Bronchiectasis severity Score (BSI) | The scale is presented online. It consists of 9 items including Age, BMI(Body Mass Index), % FEV1 Predicted, Previous Hospital Admission in the past 2 years, number of exacerbations in previous year, MRC Breathlessness Score, Pseudomonas Colonisation, Colonisation with other organisms,affected lobes.
0-4 Mild Bronchiectasis. 5 - 8 Moderate Bronchiectasis. 9 + Severe Bronchiectasis. |
At baseline and updated once a year for 3 years | |
Other | Lung function (FEV1 %, FVC %, FEV1/FVC %) | Lung function would be tested by spirometry when patients visit the clinic. | 1 year | |
Other | E-FACED score | It consists of 6 items including exacerbation history in the past year, % FEV1 predicted, Age, Chronic colonization by Pseudomonas aeruginosa, n° of pulmonary lobes affected,and Dyspnea (measured by mMRC score) mild: 0-3 points, moderate: 4-6 points; and severe: 7-9 points | At baseline and updated once a year for 3 years | |
Other | Comorbidity | Comorbidity would be recorded. | At baseline and updated every year for up to 3 years | |
Primary | Sweat chloride and conductivity | Sweat chloride and conductivity is the measured analyte most directly related to the abnormal function of the cystic fibrosis transmembrane regulator (CFTR), the chloride channel that is defective in cystic fibrosis patients | within 14 days after sweat collection | |
Secondary | CFTR-mutation screening | CFTR-mutation screening will be carried out in Patients with abnormal results of Sweat Test. Mutation detection analysis will be performed in Next Generation Sequencing method using the genomic DNA extracted from peripheral whole blood. | 1 year |
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