Aspergillus and Chronic Obstructive Pulmonary Disease Evolution

Not Applicable

Completed

• Conditions: Chronic Obstructive Pulmonary Disease
• Interventions: Diagnostic Test: Questionnaries

• Registration Number: NCT03646851
• Lead Sponsor: Centre Hospitalier Universitaire, Amiens

Brief 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.

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 Timeline

• Study Start: 2018-03-15
• Study First Submitted: 2018-08-22
• Study First Submitted QC: 2018-08-23
• Study First Posted: 2018-08-24
• Primary Completion: 2019-03-15
• Study Completion: 2019-03-15
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-17
• Last Update Posted: 2020-07-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• COPD patients GOLD stage III and IV

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
COPD	Questionnaries	COPD patients GOLD stage III and IV

Primary Outcome Measures

Name	Time	Method
presence of aspergillus in sputum or respiratory samples	one year before inclusion	sputum examination

Secondary Outcome Measures

Name	Time	Method
Dyspnea with MMRC score	day of inclusion	Pulmonary function testing

Trial Locations

Locations (4)

CHU St Quentin; 🇫🇷 Saint-Quentin, France

Clinique de l'Europe; 🇫🇷 Amiens, France

CHU Amiens-Picardie; 🇫🇷 Amiens, France

CH Abbeville; 🇫🇷 Abbeville, France