Alpha 1-Antitrypsin, COPD, Lung Function Decreased
Conditions
Brief summary
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
Interventions
None listed
Sponsors
The Gambia Committee on Traditional Practices Affecting the Health of Women and Children (GAMCOTRAP)
Permian Health Lung Institute
Study design
Observational model
ECOLOGIC_OR_COMMUNITY
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
FEMALE
Age
15 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Prevalence of lung function Impairment as measured by spirometry | Through study completion, an average of 1 year | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Prevalence of Type II (Eosinophilic) inflammation in Gambian Women | Through study completion, an average of 1 year | 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. |
Countries
The Gambia
Outcome results
None listed