An observational study in COPD, Lung Function Decreased and Alpha 1-Antitrypsin, sponsored by Permian Health Lung Institute. Not yet recruiting at 1 site in Gambia. Open to female participants aged 15 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-09-08.
Sponsored by Permian Health Lung Institute · Observational
The goal of this cross-sectional observational study is to estimate the prevalence of lung function impairment as measured by spirometry in a population of Gambian women aged 15 and older. The main question[s] it aims to answer are:
Consenting participants will undergo
5,520 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 856 are open to participants now.
This study's planned enrollment of 350 is above the median of 158 across 1,497 observational studies indexed under Pulmonary Disease, Chronic Obstructive.
Browse Pulmonary Disease, Chronic Obstructive studies →This is the only study on the registry with Permian Health Lung Institute as lead sponsor.
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All women older than 15 years in The Gambia
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Exclusion criteria:
Gambian women aged 15 and older with lung function impairment as measured by spirometry
Prevalence of lung function Impairment as measured by spirometry
Certified technicians will perform Spirometry testing to measure lung function parameters such as FEV1, FVC, and FEV1/FVC ratio. Results will be interpreted by two Pulmonologists using GLI reference equations and z-scores. Bronchodilator reversibility is defined as an improvement of over 10% in FEV1 after albuterol sulfate administration. Lung function impairment will be assessed based on z-scores, with normal lung function being z-scores greater than -1.645, mild impairment between -1.65 and -2.5, moderate impairment between -2.51 and -4, and severe impairment below -4.1.
Time frame: Through study completion, an average of 1 year
Prevalence of Type II (Eosinophilic) inflammation in Gambian Women
FENO measurements will be taken using handheld devices called NIOX VERO. These devices are compliant with guidelines set by the American Thoracic Society and European Respiratory Society. To measure FENO, participants will be instructed to exhale into the device through a filtered mouthpiece. The exhaling process will be regulated to maintain a controlled flow rate and pressure for a duration of 10 seconds.
Time frame: Through study completion, an average of 1 year
Plan to share: No
This study is not yet recruiting, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.
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Pulmonary Disease, Chronic Obstructive →