NCT05029349

Brief Summary

This is a prospective interventional study to determine whether the profile of volatile organic compounds (VOCs) present in exhaled air (VOLATOLOM) is reproducible in stable severe COPD (Chronic Obstructive Pulmonary Disease) patients.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 7, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 31, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

October 13, 2021

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 13, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 13, 2023

Completed
Last Updated

January 28, 2022

Status Verified

January 1, 2022

Enrollment Period

1.7 years

First QC Date

July 7, 2021

Last Update Submit

January 13, 2022

Conditions

Chronic Obstructive Pulmonary Disease Severe

Keywords

Chronic Obstructive Pulmonary Disease (COPD)Volatile Organic Compounds (VOC)SevereStable

Outcome Measures

Primary Outcomes (2)

  • Volatolom measurements by mass spectrometry

    Analysis of the volatolom by mass spectrometry for stable severe COPD patients during four successive visits, 4 to 6 weeks apart.

    4 months

  • Volatolom measurements by electronic-noses

    Analysis of the volatolom by electronic noses for stable severe COPD patients during four successive visits, 4 to 6 weeks apart.

    4 months

Secondary Outcomes (4)

  • Differences in the profiles of VOCs in the exhaled air according to the smoking habits

    4 months

  • Differences in the profiles of VOCs in the exhaled air according to the background therapy

    4 months

  • Compare VOCs profiles in the exhaled air to those of patients with exhacerbated COPD (VOC-BPCO-Exa study sponsored by Hopital Foch)

    4 months

  • Compare VOCs profiles in the exhaled air to those of healthy subjects smokers or non-smokers (VOLATOPNEE study sponsored by Hopital Foch)

    4 months

Study Arms (1)

VOC analysis

OTHER

VOC analysis in exhaled air in patients hospitalised for stable severe COPD

Device: VOC analysis

Interventions

VOC analysisDEVICE

VOC analysis in exhaled air with e-noses and mass spectrometry.

VOC analysis

Eligibility Criteria

Age40 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Severe COPD (FEV ≤ 50% of theoretical values)
  • stable for at least two months,
  • treated for at least one year with one (or more successively) combination of at least two inhaled drugs: either a Long-Acting Beta2-Adrenergic bronchodilator (LABA) combined with a corticosteroid (CSI), or a LABA combined with a long-acting anti-cholinergic bronchodilator (LAMA), or a triple combination LABA/LAMA/CSI;
  • History of at least one severe COPD exacerbation (treated with antibiotics and / or oral corticosteroid therapy) in the two years preceding the study;
  • Ex-smokers (at least 6 months of withdrawal) or active daily smokers of more than 10 pack-years
  • Severe dyspnea at baseline (mMRC stage ≥ 2)
  • Aged 40-85 years inclusive
  • Fluency in French
  • A signed and dated written informed consent is obtained prior to participation
  • Affiliated to a health insurance plan

You may not qualify if:

  • Severe exacerbation in the 4 months preceding the study
  • Chronic inflammatory disease (rheumatic, etc.) treated with long-term systemic corticosteroid therapy,
  • Unstable cardiovascular pathology (right or left heart failure, coronary artery disease);
  • Cancer
  • Pregnant women;
  • Deprived of liberty or under guardianship.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Foch hospital

Suresnes, 92151, France

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveLymphoma, Follicular

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsLymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Philippe Devillier, MD PhD

    Hopital Foch

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Philippe Devillier, MD PhD

CONTACT

0146252791p.devillier@hopital-foch.com

: Elisabeth Hulier-Ammar, PhD

CONTACT

drci-promotion@hopital-foch.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 7, 2021

First Posted

August 31, 2021

Study Start

October 13, 2021

Primary Completion

June 13, 2023

Study Completion

June 13, 2023

Last Updated

January 28, 2022

Record last verified: 2022-01

Locations

FR(1)