- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT04865861
The Characteristic of Airway Microbiome Profiling of COPD-bronchiectasis Overlap Patients and Its Association With Acute Exacerbation
The Characteristic of Airway Microbiome Profiling of Chronic Obstructive Pulmonary Disease-bronchiectasis Overlap Patients and Its Association With Acute Exacerbation
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.
Panoramica dello studio
Stato
Tipo di studio
Iscrizione (Anticipato)
Contatti e Sedi
Luoghi di studio
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Guangdong
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Guangzhou, Guangdong, Cina
- Reclutamento
- The First Affiliated Hospital of Guangzhou Medical University.
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Descrizione
Inclusion Criteria:
- Diagnosed as COPD, bronchiectasis or overlap based on HRCT and lung function test.
- Aged between 18 and 80 years.
Exclusion Criteria:
- Patients with active tuberculosis, traction bronchiectasis, malignancy, and severe systemic diseases.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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The number of exacerbation events
Lasso di tempo: 1 year
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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.
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1 year
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
α-diversity
Lasso di tempo: 1 hour
|
α-diversity is a measure of how diverse a sample is based on how many species here are (richness) and how abundant each species is (evenness) within that sample.
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1 hour
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β-diversity
Lasso di tempo: 1 hour
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β-diversity is used to show how different samples are from each other, based on ifferences in bacterial presence, abundance or a phylogenetic tree
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1 hour
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The positive result of bacteria culture and viral PCR.
Lasso di tempo: 1 hour
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The positive result of bacteria is defined as at least one positive potentially-pathogenic bacteria being cultured from sputum (Haemophilus influenzae, Moraxella catarrhalis, Streptococcus pneumoniae, Pseudomonas aeruginosa, or Staphylococcus aureus). The positive result of viral is defined as at least one positive viral PCR (HRV, RSV, influenza virus, parainfluenza virus, human metapneumovirus, adenovirus, human bocavirus, or coronavirus) from sputum. |
1 hour
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Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Weijie Guan, PhD, The First Affiliated Hospital of Guangzhou Medical University
- Investigatore principale: Nanshan Zhong, PhD, The First Affiliated Hospital of Guangzhou Medical University
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Anticipato)
Completamento dello studio (Anticipato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- GIRH-2020-156
Informazioni su farmaci e dispositivi, documenti di studio
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Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .