Permian Health Women's Lung Health Study

N/ANot Yet RecruitingNCT06029543

Permian Health Lung Institute350 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

350

Conditions

COPD Lung Function Decreased Alpha 1-Antitrypsin

Eligibility

Sex: FEMALEMin age: 15 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Outcomes

Primary Outcomes

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

Secondary Outcomes

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