Permian Health Women's Lung Health Study

Study Overview
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Brief Summary
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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: What is the prevalence of lung function impairment in Gambian women What is the prevalence of eosinophilic inflammation in Gambian women Consenting participants will undergo Spirometry Fractional exhaled nitric oxide (FENO) testing α1-antitrypsin testing in patients with lung function impairment as assessed by spirometry

Official Title
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Permian Health Women's Lung Health Study

Conditions
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COPD, Lung Function Decreased, Alpha 1-Antitrypsin

Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Self-identified female sex Age > 15 years: This age cutoff was chosen (as opposed to 18) because of the unique cultural norms and practices in the country where experiences and exposures occur at an earlier age than women in Western countries. Exclusion criteria: Age < 15 years Non-resident household member Any acutely unwell individual Pregnancy Any known history of active pulmonary disease (including TB) on treatment. Individuals unable or unwilling to give consent.

Ages Eligible for Study
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Minimum Age: 15 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Gambian Women<br>Gambian women aged 15 and older with lung function impairment as measured by spirometry | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Through study completion, an average of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Through study completion, an average of 1 year |