NCT03646851

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable chronic-obstructive-pulmonary-disease

Timeline
Completed

Started Mar 2018

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 15, 2018

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 22, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 24, 2018

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2019

Completed
Last Updated

November 19, 2025

Status Verified

November 1, 2025

Enrollment Period

1 year

First QC Date

August 22, 2018

Last Update Submit

November 17, 2025

Conditions

Chronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (1)

  • presence of aspergillus in sputum or respiratory samples

    sputum examination

    one year before inclusion

Secondary Outcomes (1)

  • Dyspnea with MMRC score

    day of inclusion

Study Arms (1)

COPD

EXPERIMENTAL

COPD patients GOLD stage III and IV

Diagnostic Test: Questionnaries

Interventions

QuestionnariesDIAGNOSTIC_TEST

patients will have to do a sputum and to complete some questionnaries

COPD

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • COPD patients GOLD stage III and IV

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

CH Abbeville

Abbeville, France

Location

CHU Amiens-Picardie

Amiens, 80054, France

Location

Clinique de l'Europe

Amiens, France

Location

CHU St Quentin

Saint-Quentin, France

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 22, 2018

First Posted

August 24, 2018

Study Start

March 15, 2018

Primary Completion

March 15, 2019

Study Completion

March 15, 2019

Last Updated

November 19, 2025

Record last verified: 2025-11

Locations

FR(4)