Clinical trial NCT06029543: Permian Health Women's Lung Health Study
Official title: Permian Health Women's Lung Health Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: COPD
Lung Function Decreased
Alpha 1-Antitrypsin
Lead sponsor: Permian Health Lung Institute
Sponsor class: OTHER
Collaborators: name: The Gambia Committee on Traditional Practices Affecting the Health of Women and Children (GAMCOTRAP)
First posted: 2023-09-08
Enrollment: 350
Sex: FEMALE
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: All women older than 15 years in The Gambia

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


Eligibility criteria: 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.

Primary outcomes:
measure: Prevalence of lung function Impairment as measured by spirometry
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
measure: Prevalence of Type II (Eosinophilic) inflammation in Gambian Women
timeFrame: Through study completion, an average of 1 year
Other outcomes:
Locations:
city: Kanifing
country: Gambia
facility: Gamcotrap
Study officials:
References:
citation: Ale BM, Ozoh OB, Gadanya MA, Li Y, Harhay MO, Adebiyi AO, Adeloye D. Estimating the prevalence of COPD in an African country: evidence from southern Nigeria. J Glob Health Rep. 2022;6:e2022049. doi: 10.29392/001c.38200. Epub 2022 Sep 15.
citation: Chan-Yeung M, Ait-Khaled N, White N, Ip MS, Tan WC. The burden and impact of COPD in Asia and Africa. Int J Tuberc Lung Dis. 2004 Jan;8(1):2-14.
citation: Halbert RJ, Natoli JL, Gano A, Badamgarav E, Buist AS, Mannino DM. Global burden of COPD: systematic review and meta-analysis. Eur Respir J. 2006 Sep;28(3):523-32. doi: 10.1183/09031936.06.00124605. Epub 2006 Apr 12.
citation: Stoller JK, Sandhaus RA, Turino G, Dickson R, Rodgers K, Strange C. Delay in diagnosis of alpha1-antitrypsin deficiency: a continuing problem. Chest. 2005 Oct;128(4):1989-94. doi: 10.1378/chest.128.4.1989.
citation: Chapman KR, Chorostowska-Wynimko J, Koczulla AR, Ferrarotti I, McElvaney NG. Alpha 1 antitrypsin to treat lung disease in alpha 1 antitrypsin deficiency: recent developments and clinical implications. Int J Chron Obstruct Pulmon Dis. 2018 Jan 31;13:419-432. doi: 10.2147/COPD.S149429. eCollection 2018.
citation: American Thoracic Society; European Respiratory Society. American Thoracic Society/European Respiratory Society statement: standards for the diagnosis and management of individuals with alpha-1 antitrypsin deficiency. Am J Respir Crit Care Med. 2003 Oct 1;168(7):818-900. doi: 10.1164/rccm.168.7.818. No abstract available.