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Sponsor study identifier
observational
220
1 country
1
Study Start
May 1, 2021
Actual (reported)Primary Completion
June 30, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
June 30, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
The overlap between chronic obstructive pulmonary disease (COPD) and bronchiectasis is a neglected area of research, and it is not covered by guidelines for clinical practice. COPD and bronchiectasis share common symptoms of cough with sputum production and susceptibility to recurrent exacerbations driven by new or persistent infection. Physiological criteria for the diagnosis of COPD and structural criteria for the diagnosis of bronchiectasis create the possibility for individual patients to fulfil both, resulting conceptually in either co-diagnosis or an overlap syndrome between the two conditions. The prevalence of this overlap will vary depending on the respective prevalence of COPD and bronchiectasis in the population under consideration. A recent study of 201 COPD patients with airway wall abnormalities typical of bronchiectasis confirmed an association with exacerbations and was predictive of mortality over 48 months. A further, single-centre study demonstrated a near three-fold increased mortality rate, with patients with bronchiectasis and associated COPD having a 5-year mortality of 55%, compared with 20% in those with bronchiectasis without COPD. Airflow obstruction is perhaps best considered one marker of disease severity in bronchiectasis. Disease-associated exacerbations have a major effect on patient healthcare costs as well as quality of life due to increased lung damage and mortality risk. Microorganisms such as Pseudomonas aeruginosa and, to a lesser extent, other Gram-negative and Gram-positive microorganisms identified in culture, have been linked to disease progression, poor clinical outcomes in bronchiectasis and driving airway neutrophil-mediated inflammation. The microbiome has the potential to provide valuable information regarding disease phenotype/endotype, treatment responses and targets for future therapy.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 30, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 25, 2021
Actual (reported)April 29, 2021
Actual (reported)May 1, 2021
Actual (reported)June 30, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
June 30, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
The number of exacerbation events
The exacerbation of bronchiectasis is defined as a deterioration in three or more of the following key symptoms for at least 48 h: cough; sputum volume and/or consistency; sputum purulence; breathlessness and/or exercise tolerance; fatigue and/or malaise; haemoptysis AND a clinician determines that a change in bronchiectasis treatment is required.
1 year
α-diversity
1 hour
β-diversity
1 hour
This is a single-center prospective observational study in which we will enroll the patients diagnosed as COPD, bronchiectasis or overlap (with or without chronic cough, daily sputum production) from the First Affiliated Hospital of Guangzhou Medical University between May 2020 and June 2023.
The First Affiliated Hospital of Guangzhou Medical University.
Guangzhou, Guangdong, China
serum; plasma; blood cell; sputum
Weijie Guan, PhD
The First Affiliated Hospital of Guangzhou Medical University
Nanshan Zhong, PhD
The First Affiliated Hospital of Guangzhou Medical University
First Submitted
April 25, 2021
First Posted
April 29, 2021
Study Start
May 1, 2021
Actual (reported)Primary Completion
June 30, 2023
Estimated (date passed)The positive result of bacteria culture and viral PCR.
1 hour
Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
June 30, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
May 4, 2021
Record last verified: 2021-05
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Source: ClinicalTrials.gov.
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