Clinical Trials Logo
  1. Home
  2. Chronic Obstructive Pulmonary Disease
  3. NCT03534557
  4. Details
NCT03534557 Clinical Trial

FEV1/FEV6 and FEV6 as an Alternative for FEV1/FVC and FVC in Bolivian Subjects

Copd Clinical Trial

Official title:
FEV1/FEV6 and FEV6 as an Alternative for FEV1/FVC and FVC in the Detection of Airway Obstruction in a Small Group of Bolivian Subjects

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03534557
Other study ID # StLucFEV6
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 2, 2018
Est. completion date September 4, 2018

Study information
Verified date September 2018
Source Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Comparison of FEV1/FEV6 and FEV6 as an alternative for FEV1/FVC and FCV in the detection of airway obstruction in a Bolivian population

Description:

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
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.

Recruitment information / eligibility
Status Completed
Enrollment 70
Est. completion date September 4, 2018
Est. primary completion date June 18, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- adult smoker suspected of COPD

Exclusion Criteria:

- unable to perform spirometry

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• FEV6 spirometry
During the same spirometry, to compare the relative value of FVC and FEV6

Locations
Country Name City State
Bolivia Clínica del Pulmón Santa Cruz

Sponsors (1)
Lead Sponsor Collaborator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Country where clinical trial is conducted

Bolivia, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 one measurement lasts 10 minutes
See also
  Status Clinical Trial Phase
Enrolling by invitation NCT06000696 - Healthy at Home Pilot
Active, not recruiting NCT03927820 - A Pharmacist-Led Intervention to Increase Inhaler Access and Reduce Hospital Readmissions (PILLAR) N/A
Completed NCT04043728 - Addressing Psychological Risk Factors Underlying Smoking Persistence in COPD Patients: The Fresh Start Study N/A
Completed NCT04105075 - COPD in Obese Patients
Recruiting NCT05825261 - Exploring Novel Biomarkers for Emphysema Detection
Active, not recruiting NCT04075331 - Mepolizumab for COPD Hospital Eosinophilic Admissions Pragmatic Trial Phase 2/Phase 3
Terminated NCT03640260 - Respiratory Regulation With Biofeedback in COPD N/A
Recruiting NCT04872309 - MUlti-nuclear MR Imaging Investigation of Respiratory Disease-associated CHanges in Lung Physiology
Recruiting NCT05145894 - Differentiation of Asthma/COPD Exacerbation and Stable State Using Automated Lung Sound Analysis With LungPass Device
Withdrawn NCT04210050 - Sleep Ventilation for Patients With Advanced Hypercapnic COPD N/A
Terminated NCT03284203 - Feasibility of At-Home Handheld Spirometry N/A
Recruiting NCT06110403 - Impact of Long-acting Bronchodilator- -Corticoid Inhaled Therapy on Ventilation, Lung Function and Breathlessness Phase 1/Phase 2
Active, not recruiting NCT06040424 - Comparison of Ipratropium / Levosalbutamol Fixed Dose Combination and Ipratropium and Levosalbutamol Free Dose Combination in pMDI Form in Stable Chronic Obstructive Pulmonary Disease (COPD) Patients Phase 3
Recruiting NCT05865184 - Evaluation of Home-based Sensor System to Detect Health Decompensation in Elderly Patients With History of CHF or COPD
Recruiting NCT04868357 - Hypnosis for the Management of Anxiety and Breathlessness During a Pulmonary Rehabilitation Program N/A
Completed NCT01892566 - Using Mobile Health to Respond Early to Acute Exacerbations of COPD in HIV N/A
Completed NCT04119856 - Outgoing Lung Team - a Cross-sectorial Intervention in Patients With COPD N/A
Completed NCT04485741 - Strados System at Center of Excellence
Completed NCT03626519 - Effects of Menthol on Dyspnoea in COPD Patients N/A
Recruiting NCT04860375 - Multidisciplinary Management of Severe COPD N/A