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NCT Number: NCT06029543

Permian Health Women's Lung Health Study

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

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Key information

Conditions

COPD Alpha 1-Antitrypsin Chronic Disease Congenital, Hereditary, and Neonatal Diseases and Abnormalities Digestive System Diseases Disease Attributes Emphysema Genetic Diseases, Inborn Liver Diseases Lung Diseases Lung Diseases, Obstructive Lung Function Decreased Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiration Disorders Respiratory Insufficiency Respiratory Tract Diseases Subcutaneous Emphysema alpha 1-Antitrypsin Deficiency

Age range

15 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Prevalence of lung function Impairment as measured by spirometry

    Time frame: 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 outcomes

  1. Prevalence of Type II (Eosinophilic) inflammation in Gambian Women

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Permian Health Lung Institute

Other

Collaborators

  • The Gambia Committee on Traditional Practices Affecting the Health of Women and Children (GAMCOTRAP)

Registry information

Acronym: WLHS

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Sep 8, 2023
Registry last updated
Sep 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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