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Aspergillus and Chronic Obstructive Pulmonary Disease Evolution (AspergBPCO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03646851
Recruitment Status : Recruiting
First Posted : August 24, 2018
Last Update Posted : August 24, 2018
Information provided by (Responsible Party):
Centre Hospitalier Universitaire, Amiens

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.

Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease Diagnostic Test: Questionnaries Not Applicable

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)

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Impact of Aspergillus on Chronic Obstructive Pulmonary Disease Evolution
Actual Study Start Date : March 15, 2018
Actual Primary Completion Date : March 15, 2018
Estimated Study Completion Date : March 15, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD Lung Diseases

Arm Intervention/treatment
Experimental: COPD
COPD patients GOLD stage III and IV
Diagnostic Test: Questionnaries
patients will have to do a sputum and to complete some questionnaries

Primary Outcome Measures :
  1. presence of aspergillus in sputum or respiratory samples [ Time Frame: one year before inclusion ]
    sputum examination

Secondary Outcome Measures :
  1. Dyspnea with MMRC score [ Time Frame: day of inclusion ]
    Pulmonary function testing

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • COPD patients GOLD stage III and IV

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03646851

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Contact: Claire Andréjak, MD +330322088000

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CH Abbeville Recruiting
Abbeville, France
Contact: Estelle Hoguet, MD         
CHU Amiens-Picardie Recruiting
Amiens, France, 80054
Contact: Claire Andréjak, MD         
Clinique de l'Europe Recruiting
Amiens, France
Contact: Benoit Nicolas, MD         
CHU St Quentin Recruiting
Saint-Quentin, France
Contact: Youcef Douadi, MD         
Sponsors and Collaborators
Centre Hospitalier Universitaire, Amiens
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Responsible Party: Centre Hospitalier Universitaire, Amiens Identifier: NCT03646851    
Other Study ID Numbers: PI2017_843_0024
First Posted: August 24, 2018    Key Record Dates
Last Update Posted: August 24, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases