Clinical Impact of Fungal Domestic Environmental Exposure on COPD Patients (FungiCOPD)

Circulation of Pathogenic Fungi in the Domestic Environment: Clinical Impact of Mould and Pneumocystis Jirovecii Exposure on COPD Patients

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.

Study Overview

• Status: Completed
• Conditions: COPD; Environmental Exposure; Pulmonary Fungal Diseases

Detailed Description

The investigators will focus on both the patient and its domestic environment. More precisely, for 80 patients, the investigators will measure mould domestic exposure (determination of mould frequency during an environmental investigation at the patient's home), search for mould sensitization and colonization (complete bio clinical check-up including spirometry, inflammatory and mycological markers at inclusion), and do a clinical follow-up of exacerbation's (frequency and severity). At last, clinical and environmental mould and P. jirovecii isolates will be characterized at the phenotypic and genotypic level.

• Study Type: Observational
• Enrollment (Actual): 65

Contacts and Locations

Study Locations

• France
  • Lille, France, 59037
    • Lille University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Primary care clinic

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: University Hospital, Lille
• Collaborators: Merck Sharp & Dohme LLC; Pfizer; Gilead Sciences; Région Nord-Pas de Calais, France
• Investigators: Study Director: Emilie Fréalle, PharmD, PhD, Lille University Hospital; Principal Investigator: Stéphanie Fry, MD, Lille University Hospital

Study record dates

Study Major Dates

• Study Start: August 1, 2011
• Primary Completion (Actual): October 1, 2017
• Study Completion (Actual): October 1, 2017

Study Registration Dates

• First Submitted: April 22, 2013
• First Submitted That Met QC Criteria: December 11, 2014
• First Posted (Estimate): December 17, 2014

Study Record Updates

• Last Update Posted (Actual): December 22, 2017
• Last Update Submitted That Met QC Criteria: December 21, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Bacterial Infections and Mycoses; Mycoses; Lung Diseases, Fungal
• Other Study ID Numbers: 2010_35; 2010-A01379-30 (Other Identifier: ID RCB number, ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO