Aspergillus and Chronic Obstructive Pulmonary Disease Evolution (AspergBPCO)
Primary Purpose
Chronic Obstructive Pulmonary Disease
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Questionnaries
Sponsored by
About this trial
This is an interventional health services research trial for Chronic Obstructive Pulmonary Disease
Eligibility Criteria
Inclusion Criteria:
- COPD patients GOLD stage III and IV
Exclusion Criteria:
- Cystic fibrosis
- Pulmonary fibrosis
- hematological malignancy
- known aspergilloma
- allergic bronchopulmonary aspergillosis
Sites / Locations
- CH Abbeville
- CHU Amiens-Picardie
- Clinique de l'Europe
- CHU St Quentin
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
COPD
Arm Description
COPD patients GOLD stage III and IV
Outcomes
Primary Outcome Measures
presence of aspergillus in sputum or respiratory samples
sputum examination
Secondary Outcome Measures
Dyspnea with MMRC score
Pulmonary function testing
Full Information
NCT ID
NCT03646851
First Posted
August 22, 2018
Last Updated
July 17, 2020
Sponsor
Centre Hospitalier Universitaire, Amiens
1. Study Identification
Unique Protocol Identification Number
NCT03646851
Brief Title
Aspergillus and Chronic Obstructive Pulmonary Disease Evolution
Acronym
AspergBPCO
Official Title
Impact of Aspergillus on Chronic Obstructive Pulmonary Disease Evolution
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
March 15, 2018 (Actual)
Primary Completion Date
March 15, 2019 (Actual)
Study Completion Date
March 15, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire, Amiens
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
COPD
Arm Type
Experimental
Arm Description
COPD patients GOLD stage III and IV
Intervention Type
Diagnostic Test
Intervention Name(s)
Questionnaries
Intervention Description
patients will have to do a sputum and to complete some questionnaries
Primary Outcome Measure Information:
Title
presence of aspergillus in sputum or respiratory samples
Description
sputum examination
Time Frame
one year before inclusion
Secondary Outcome Measure Information:
Title
Dyspnea with MMRC score
Description
Pulmonary function testing
Time Frame
day of inclusion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
COPD patients GOLD stage III and IV
Exclusion Criteria:
Cystic fibrosis
Pulmonary fibrosis
hematological malignancy
known aspergilloma
allergic bronchopulmonary aspergillosis
Facility Information:
Facility Name
CH Abbeville
City
Abbeville
Country
France
Facility Name
CHU Amiens-Picardie
City
Amiens
ZIP/Postal Code
80054
Country
France
Facility Name
Clinique de l'Europe
City
Amiens
Country
France
Facility Name
CHU St Quentin
City
Saint-Quentin
Country
France
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Aspergillus and Chronic Obstructive Pulmonary Disease Evolution
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