Permian Health Women's Lung Health Study
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age15+
SponsorPermian Health Lung Institute
About this trial
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
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
Age < 15 years
Non-resident household member
Any acutely unwell individual
Pregnancy
Trial population
All women older than 15 years in The Gambia
Trial design
Design model
Ecologic or community
Time perspective
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
350 Participants
are grouped into 1 trial groupGroup A: Gambian Women
Trial outcomes
Primary outcomes
1
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 yearSecondary outcomes
1
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 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
Permian Health Lung Institute
Lead sponsor
The Gambia Committee on Traditional Practices Affecting the Health of Women and Children (GAMCOTRAP)
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: