AspergBPCO: Aspergillus and Chronic Obstructive Pulmonary Disease Evolution

• Sponsor: Centre Hospitalier Universitaire, Amiens (Other)
• Overall Status: Completed
• CT.gov ID: NCT03646851
• Collaborator: (none)
• Enrollment: 100
• Locations: 4
• Arm: 1
• Actual Duration (Months): 12
• Patients Per Site: 25
• Patients Per Site Per Month: 2.1

Study Details

Study Description

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	N/A

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)

Study Design

• Study Type: Interventional
• Actual 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: Mar 15, 2018
• Actual Primary Completion Date: Mar 15, 2019
• Actual Study Completion Date: Mar 15, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. presence of aspergillus in sputum or respiratory samples [one year before inclusion]

   sputum examination

Secondary Outcome Measures

1. Dyspnea with MMRC score [day of inclusion]

   Pulmonary function testing

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CH Abbeville	Abbeville		France
2	CHU Amiens-Picardie	Amiens		France	80054
3	Clinique de l'Europe	Amiens		France
4	CHU St Quentin	Saint-Quentin		France

Sponsors and Collaborators

• Centre Hospitalier Universitaire, Amiens

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Centre Hospitalier Universitaire, Amiens
• ClinicalTrials.gov Identifier: NCT03646851
• Other Study ID Numbers: PI2017_843_0024
• First Posted: Aug 24, 2018
• Last Update Posted: Jul 20, 2020
• Last Verified: Jul 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive

Study Results

No Results Posted as of Jul 20, 2020