Aspergillus and Chronic Obstructive Pulmonary Disease Evolution (AspergBPCO)

Impact of Aspergillus on Chronic Obstructive Pulmonary Disease Evolution

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.

Study Overview

• Status: Completed
• Conditions: Chronic Obstructive Pulmonary Disease
• Intervention / Treatment: Diagnostic test: Questionnaries

Detailed 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)

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Abbeville, France
    • CH Abbeville
  • Amiens, France, 80054
    • CHU Amiens-Picardie
  • Amiens, France
    • Clinique de l'Europe
  • Saint-Quentin, France
    • CHU St Quentin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• COPD patients GOLD stage III and IV

Exclusion Criteria:

• Cystic fibrosis
• Pulmonary fibrosis
• hematological malignancy
• known aspergilloma
• allergic bronchopulmonary aspergillosis

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: COPD; COPD patients GOLD stage III and IV	Diagnostic test: Questionnaries; patients will have to do a sputum and to complete some questionnaries

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
presence of aspergillus in sputum or respiratory samples	sputum examination	one year before inclusion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dyspnea with MMRC score	Pulmonary function testing	day of inclusion

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire, Amiens

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2018
• Primary Completion (Actual): March 15, 2019
• Study Completion (Actual): March 15, 2019

Study Registration Dates

• First Submitted: August 22, 2018
• First Submitted That Met QC Criteria: August 23, 2018
• First Posted (Actual): August 24, 2018

Study Record Updates

• Last Update Posted (Actual): July 20, 2020
• Last Update Submitted That Met QC Criteria: July 17, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: PI2017_843_0024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

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