Investigating the Clinical Features and Prognosis of Bronchiectasis Adult Patients

Investigating the Clinical Features and Prognosis of Bronchiectasis Adult Patients: a Multi-center, Primary Data, Cohort Study (ICON)

Bronchiectasis is a chronic respiratory disease characterized by permanent bronchiectasis.The incidence and prevalence of bronchiectasis have assumed continuously grows in global. Different from overseas, bronchiectasis is common disease in China. This study will collect data from the real-world bronchiectasis database and follow up for one year, describe the bronchiectasis exacerbation rate and proportions for frequent exacerbation, clinical features and prognosis of bronchiectasis exacerbation, the treatment pattern (when clinically stable) during follow-up period; and describe characteristics of bronchiectasis at baseline. This study will also explore potential baseline risk factors for bronchiectasis exacerbation during follow-up period.

Study Overview

• Status: Not yet recruiting
• Conditions: Bronchiectasis Adult
• Intervention / Treatment: Other: No intervention

Detailed Description

Bronchiectasis is a chronic respiratory disease characterized by permanent bronchiectasis, its main clinical symptoms are cough, dyspnea, hemoptysis and recurrent respiratory tract infections. The incidence and prevalence of bronchiectasis have assumed continuously grows in global. Different from overseas, bronchiectasis is common disease in China. In 2013, the prevalence rate of bronchiectasis in Chinese residents over 40 years old was 1,200/100,000. As lack of large epidemiological data in China, the prevalence rate may still be underestimated, which needs more attention and research.

Bronchiectasis has heavy disease burden, characterized by recurrent acute exacerbations, high mortality, poor prognosis and heavy economic burden. The key points of bronchiectasis treatment strategy include exacerbation prevention, number of exacerbations reduction, prognosis improvement and then the quality of patients' life improvement. Therefore, it is important to describe the clinical features and prognosis of bronchiectasis (especially the incidence of acute exacerbations and the proportion of frequent exacerbations), and it would be helpful to understand the characteristics of bronchiectasis and standardize related diagnosis and treatment strategy.

This study will collect data from the real-world bronchiectasis database and follow up for one year, describe the bronchiectasis exacerbation rate and proportions for frequent exacerbation, clinical features and prognosis of bronchiectasis exacerbation, the treatment pattern (when clinically stable) during follow-up period; and describe characteristics of bronchiectasis at baseline. This study will also explore potential baseline risk factors for bronchiectasis exacerbation during follow-up period.

• Study Type: Observational
• Enrollment (Anticipated): 1250

Contacts and Locations

• Study Contact: Name: Jieming Qu; Phone Number: 86-021-64370045; Email: jmqu0906@163.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200025
      • Ruijin Hospital, Medical School of Shanghai Jiaotong University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

It is designed that from 2021 Q4 to 2022 Q2, 1,250 bronchiectasis patients will be enrolled from 30 participating sites in China.

*Bronchiectasis exacerbation defined as patients have three or more of the following six symptoms including cough, expectoration, purulent sputum, dyspnoea, fatigue, haemoptysis, and these symptoms persist more than 48 hours, and physicians prescribe systemic antibiotics due to these symptoms.

Description

Inclusion Criteria:

• Patients diagnosed with bronchiectasis (according to the Chinese consensus, patient's previous chest CT examination must show bronchiectasis).
• Patients with age ≥18 years old.

Exclusion Criteria:

• Bronchiectasis due to known cystic fibrosis.
• With acute bronchiectasis exacerbation within 4 weeks before enrolment.
• Participated in any interventional clinical trial within 6 months before enrolment.
• Patients who are unable or unwilling to provide informed consent.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bronchiectasis exacerbation times	Bronchiectasis exacerbation times (per person per year) during one year follow up.	one year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportions of different bronchiectasis exacerbations	Proportions of different bronchiectasis exacerbations(0, 1, 2, 3, ≥4 exacerbations per person per year) during one year follow-up.	one year

Collaborators and Investigators

• Sponsor: Ruijin Hospital
• Collaborators: AstraZeneca Investment (China) Co., Ltd

Study record dates

Study Major Dates

• Study Start (Anticipated): November 1, 2021
• Primary Completion (Anticipated): April 30, 2022
• Study Completion (Anticipated): June 30, 2023

Study Registration Dates

• First Submitted: July 9, 2021
• First Submitted That Met QC Criteria: August 1, 2021
• First Posted (Actual): August 3, 2021

Study Record Updates

• Last Update Posted (Actual): August 3, 2021
• Last Update Submitted That Met QC Criteria: August 1, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: Bronchiectasis; Non-Interventional Study
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Bronchial Diseases; Bronchiectasis
• Other Study ID Numbers: ICON

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No