An observational study in Copd, sponsored by Cliniques universitaires Saint-Luc- Université Catholique de Louvain. Completed at 1 site in Bolivia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-09-05.
Sponsored by Cliniques universitaires Saint-Luc- Université Catholique de Louvain · Observational
Comparison of FEV1/FEV6 and FEV6 as an alternative for FEV1/FVC and FCV in the detection of airway obstruction in a Bolivian population
The data of consecutive adult smoker patients, referred to the Clínica del Pulmón (Santa Cruz, Bolivia), between May 2018 and June 2018, will be analyzed. All the patients are current or ex-smokers, complaining of dyspnea, cough or expectorations. Spirometry measurements will be performed with a Medisoft Body Box 5500 by one highly trained and experienced pulmonologist according to the guidelines of the ATS/ERS.
The criteria used to detect airway obstruction are either the fixed cut-off points according to GOLD recommendations (FEV1/FVC\<0.70) or the lower limit of normal (FEV1/FVC\<LLN). These indices will be compared to a fixed cut-off FEV1/FEV6 \<0.73 as proposed by Vandevoorde et al. or to a FEV1/FV6 ration \< LLN. Reference equations used are those of Caucasians from the NHANES III survey.
Statistical tests will be done using IBM SPSS 24 software. Cohen's κ will be used to determine if there is an agreement between the definitions of airway obstruction.
5,520 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 856 are open to participants now.
This study's enrollment of 70 is below the median of 158 across 1,497 observational studies indexed under Pulmonary Disease, Chronic Obstructive.
Browse Pulmonary Disease, Chronic Obstructive studies →Cliniques universitaires Saint-Luc- Université Catholique de Louvain is the lead sponsor of 350 studies on the registry; 64 are open to participants now.
Counted across the registry records on this site, refreshed daily.
COPD
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
FEV1/FVC and FEV1/FEV6 will be compared within the same cohort of COPD patients
Diagnostic Test: FEV6 spirometry
During the same spirometry, to compare the relative value of FVC and FEV6
The aim of this preliminary study is to determine if the criteria of airway obstruction using FEV6 as a surrogate of FVC are transposable to a non-selected Bolivian population
see above
Time frame: one measurement lasts 10 minutes
Plan to share: Undecided
No publications or documents are linked to this record.
Ran from May 2018 to primary completion in Jun 2018, 1 month.
Of 466 non-industry observational studies under Pulmonary Disease, Chronic Obstructive, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 64. This study's 1 month is below that.
Counting every sponsor, half of 586 studies reached it within 26 months; a quarter within 14 and three quarters within 58.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2018. You cannot join it, but the record below documents what was studied.
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