Permian Health Women's Lung Health Study

COPD Clinical Trial

— WLHS  

Official title:

Permian Health Women's Lung Health Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06029543
• Other study ID #: WLHS2023001
• Status: Not yet recruiting
• Start date: December 2023
• Est. completion date: December 2026

Study information

• Verified date: August 2023
• Source: Permian Health Lung Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 350
• Est. completion date: December 2026
• Est. primary completion date: December 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 15 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Alpha 1-Antitrypsin
• Alpha 1-Antitrypsin Deficiency
• COPD
• Lung Function Decreased

Locations

Country	Name	City	State
Gambia	Gamcotrap	Kanifing

Sponsors (2)

Lead Sponsor	Collaborator
Permian Health Lung Institute	The Gambia Committee on Traditional Practices Affecting the Health of Women and Children (GAMCOTRAP)

Country where clinical trial is conducted

Gambia, 

References & Publications (6)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Through study completion, an average of 1 year
Secondary	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.	Through study completion, an average of 1 year