Aspergillus and Chronic Obstructive Pulmonary Disease Evolution

Chronic Obstructive Pulmonary Disease Clinical Trial

— AspergBPCO  

Official title:

Impact of Aspergillus on Chronic Obstructive Pulmonary Disease Evolution

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03646851
• Other study ID #: PI2017_843_0024
• Status: Completed
• Phase: N/A
• Start date: March 15, 2018
• Est. completion date: March 15, 2019

Study information

• Verified date: July 2020
• Source: Centre Hospitalier Universitaire, Amiens
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a prospective multicenter cohort study which includes all consecutive COPD patients who come for a visit in one the participating pneumologist. They will have to do a sputum and to complete some questionnaries. Questionnaries will be redone by phone after 1 and 3 months and during the visit after 6 months. We will correlate aspergillus presence in sputum with quality of life (QoL), and COPD symptoms evaluated by questionnaires.

Description:

Aspergillosis disease is a growing problem. These diseases are not yet uncommon in chronic obstructive pulmonary disease patients. (COPD).

Aspergillosis disease are very difficult to be diagnosed or treated. Isolation of aspergillus in sputum of patients is not always responsible of a real disease. Need of treatment is discussed. That is why, we will conduct a prospective cohort study to evaluate aspergillus rate in respiratory samples of COPD patients (GOLD stage III or IV)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: March 15, 2019
• Est. primary completion date: March 15, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• COPD patients GOLD stage III and IV

Exclusion Criteria:

• Cystic fibrosis

• Pulmonary fibrosis

• hematological malignancy

• known aspergilloma

• allergic bronchopulmonary aspergillosis

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Diagnostic Test:
• Questionnaries
patients will have to do a sputum and to complete some questionnaries

Locations

Country	Name	City	State
France	CH Abbeville	Abbeville
France	CHU Amiens-Picardie	Amiens
France	Clinique de l'Europe	Amiens
France	CHU St Quentin	Saint-Quentin

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire, Amiens

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	presence of aspergillus in sputum or respiratory samples	sputum examination	one year before inclusion
Secondary	Dyspnea with MMRC score	Pulmonary function testing	day of inclusion