COPD Clinical Trial
— FungiCOPDOfficial title:
Circulation of Pathogenic Fungi in the Domestic Environment: Clinical Impact of Mould and Pneumocystis Jirovecii Exposure on COPD Patients
Verified date | December 2017 |
Source | University Hospital, Lille |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Fungal infections could play a role in chronic obstructive pulmonary disease (COPD) patient's
exacerbations and in lung function impairment. In fact, Aspergillus fumigatus is often
isolated from respiratory samples, but few data are available about its clinical
significance. Aspergillus colonization could be associated to a higher risk of invasive
pulmonary aspergillosis (IPA), which, in COPD patients, is characterized by a 2% incidence
(probably underestimated) and a high mortality (72 to 95%). Similarly, detection of
anti-Aspergillus antibodies is quite frequent in COPD patients but its significance and
usefulness for aspergillosis diagnosis and follow-up have not been assessed. Furthermore,
several studies suggest a frequent carriage of Pneumocystis jirovecii, reaching 37-55%, with
a higher frequency in the most severe COPD stages and a possible role of colonisation in the
occurrence and progression of COPD.
As these colonization and sensitization phenomena could be related to domestic exposure to
airborne or, for P. jirovecii, to human reservoirs, the investigators set-up a study in order
to (i) Evaluate how domestic exposure to mould or to P. jirovecii could impact fungal
colonization and sensitization frequency in COPD patients, (ii) Study the relationship
between these fungal colonization/sensitization phenomena and lung function impairment in the
course of COPD and (iii) Have a better understanding of mould and P. jirovecii circulation in
the close environment of patients (between airborne, human reservoirs and patients).
In fine, this study will provide data (i) On fungal contamination levels (species and conidia
concentration) of COPD patient's homes in a French region, (ii) On the relationship between
fungal exposure level and colonization/sensitization phenomena, (iii) On the role of fungal
colonization/sensitization in lung function impairment, (iv) To design diagnostic,
therapeutic, and preventive options for the management of COPD patients, taking into account
fungal environmental exposure and colonization/sensitization impact on the evolution of the
disease.
Status | Completed |
Enrollment | 65 |
Est. completion date | October 2017 |
Est. primary completion date | October 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 35 Years to 90 Years |
Eligibility |
Inclusion Criteria: - 35 to 90 years old male or female, - COPD patient (I to IV stages), - Medical consultation or severe COPD exacerbation requiring hospitalization. Exclusion Criteria: - Active tuberculosis. - Cancer (or prior anticancer therapy within the past 3 years). - Diffuse bronchiectasia. - Cystic fibrosis. - Asthma. - Any other pulmonary disease (sarcoidosis, pulmonary fibrosis, pneumoconiosis,…). - Prior anti- P. jirovecii or antifungal treatment within the past 6 months. - Pregnant or breast-feeding females. - Patient with no social insurance. - Patient unwilling to comply with the protocol. - Patient unable to understand the study and its objectives. - Patient under guardianship. |
Country | Name | City | State |
---|---|---|---|
France | Lille University Hospital | Lille |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Lille | Gilead Sciences, Merck Sharp & Dohme Corp., Pfizer, Région Nord-Pas de Calais, France |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Comparison of domestic mould exposure of colonized/sensitized and non colonized/non sensitized COPD patients. | The primary endpoint will be the difference between " colonized/sensitized " and " non colonized/non sensitized " groups in change of mould exposure level. Mould exposure level is a numeric value which corresponds to the concentration of fungal conidia in the dust catcher (measurement by culture and quantitative real-time PCR). | Mould exposure and colonization/sensitization will be measured at inclusion. Patients will undergo a bioclinical checkup 18 months after inclusion. |
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