Screening for cystic fibrosis in Chinese adults with bronchiectasis

The Clinical and Genetic Characteristics of Cystic Fibrosis and Cystic Fibrosis Disorders in Chinese Adults With Bronchiectasis

This study is trying to see how common cystic fibrosis is in Chinese adults with bronchiectasis and to understand their specific symptoms and genetic factors to improve diagnosis and treatment.

Quick facts

• Study type: Observational
• Enrollment: 1000 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Shanghai Pulmonary Hospital, Shanghai, China (other)
• Locations: 1 site (Shanghai, Shanghai)
• Trial ID: NCT05604495 on ClinicalTrials.gov

What this trial studies

This observational study aims to investigate the prevalence and clinical characteristics of cystic fibrosis (CF) and CFTR mutations in Chinese adults diagnosed with bronchiectasis. It employs sweat tests and CFTR-mutation screening to gather data on the incidence and prognosis of CF in this population. The study is multi-centered and prospective, focusing on understanding the unique genetic factors and disease progression in Chinese patients, who often misdiagnose their condition. By identifying CF and CFTR dysfunction, the study seeks to improve diagnostic accuracy and treatment approaches for affected individuals.

Who should consider this trial

Good fit: Ideal candidates for this study are adults over 18 years old who have been diagnosed with bronchiectasis and exhibit relevant clinical symptoms.

Not a fit: Patients under 18 years old or those with incomplete essential information for data analysis will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to better diagnosis and management of cystic fibrosis in Chinese adults, ultimately improving patient outcomes.

How similar studies have performed: While the prevalence of cystic fibrosis has been well-studied in Western populations, this approach is novel in the context of Chinese adults with bronchiectasis, making it an important and untested area of research.

Eligibility criteria

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.

Where this trial is running

Shanghai, Shanghai

• Shanghai pulmonary hospital — Shanghai, Shanghai, China (RECRUITING)

Study contacts

• Study coordinator: Jin-fu Xu, MD

Conditions: Cystic Fibrosis, Pulmonary