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Aspergillus and Chronic Obstructive Pulmonary Disease Evolution (AspergBPCO)

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ClinicalTrials.gov Identifier: NCT03646851
Recruitment Status : Recruiting
First Posted : August 24, 2018
Last Update Posted : August 24, 2018
Sponsor:
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
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

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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
Criteria

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 ClinicalTrials.gov identifier (NCT number): NCT03646851


Contacts
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Contact: Claire Andréjak, MD +330322088000 andrejak.claire@chu-amiens.fr

Locations
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France
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
ClinicalTrials.gov Identifier: NCT03646851     History of Changes
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