Clinical Impact of Fungal Domestic Environmental Exposure on COPD Patients

NCT02318524 | Completed DMC

• 2 other identifiers: 2010_352010-A01379-30
• Study Type: observational
• Target: 65
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

COPD; Pulmonary Fungal Diseases; Environmental Exposure

Outcome Measures

Primary Outcomes (1)

• 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.

Eligibility Criteria

• Age: 35 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Primary care clinic

You may qualify if:

• to 90 years old male or female,
• COPD patient (I to IV stages),
• Medical consultation or severe COPD exacerbation requiring hospitalization.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Lille: lead
• Région Nord-Pas de Calais, France: collaborator
• Pfizer: collaborator
• Merck Sharp & Dohme LLC: collaborator
• Gilead Sciences: collaborator

Study Sites (1)

Lille University Hospital

Lille, 59037, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Sputum, serum, oropharyngeal washing, Dust catchers

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Lung Diseases, Fungal

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Mycoses; Bacterial Infections and Mycoses; Infections; Respiratory Tract Infections

Study Officials

• Emilie Fréalle, PharmD, PhD

  Lille University Hospital

  STUDY DIRECTOR

• Stéphanie Fry, MD

  Lille University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2013
• First Posted: December 17, 2014
• Study Start: August 1, 2011
• Primary Completion: October 1, 2017
• Study Completion: October 1, 2017
• Last Updated: December 22, 2017

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)