|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
16 December 2017 |
|
Main ID: |
NCT02529891 |
|
Date of registration:
|
19/08/2015 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Identification of Volatile Organic Compounds in Exhaled Air During Exacerbation of Chronic Obstructive Pulmonary Disease
LAVOLEX |
|
Scientific title:
|
Identification of Volatile Organic Compounds in Exhaled Air During Exacerbation of Chronic Obstructive Pulmonary Disease |
|
Date of first enrolment:
|
August 8, 2014 |
|
Target sample size:
|
19 |
|
Recruitment status: |
Terminated |
|
URL:
|
https://clinicaltrials.gov/show/NCT02529891 |
|
Study type:
|
Observational |
|
Study design:
|
|
|
Phase:
|
N/A
|
|
|
Countries of recruitment
|
|
France
| | | | | | | |
|
Contacts
|
|
Name:
|
Frederic COSTES, MD PhD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
CHU de SAINT-ETIENNE |
| | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria of COPD group:
- COPD stages 2 and 3 of GOLD score (30 = forced expiratory volume at one second (FEV1)
< 80% of predicted value),
- exacerbation confirmed clinically (increased dyspnea, cough or expectorations > 48
hours)
Inclusion Criteria of non COPD group:
- No smoker (<100 cigarettes/year)
Exclusion Criteria of COPD group:
- Diagnosis of COPD not confirmed.
- Instable clinical status with respiratory failure and indication of mechanical
ventilation.
- Bronchodilator treatment changed
- Antibiotic treatment started in the 10 last days before admission
Exclusion Criteria of non COPD group:
- Chronic inflammatory disease
- Any respiratory disease
- Oral corticosteroid treatment during the last month
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Chronic Obstructive Pulmonary Disease
|
|
Intervention(s)
|
|
Other: Measurement of VOC in exhaled air
|
|
Primary Outcome(s)
|
|
Spectrum of VOC measured with a portable mass spectrometer system
[Time Frame: Day 1 (within 48 hours after hospital admission for exacerbation of COPD)]
|
|
Secondary Outcome(s)
|
|
Variation in VOC spectrum in COPD patients measured with a portable mass spectrometer system
[Time Frame: 3 months after hospital discharge]
|
|
Secondary ID(s)
|
|
1208090
|
|
2012-A01072-41
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|