WLHS: Permian Health Women's Lung Health Study

• Sponsor: Permian Health Lung Institute (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT06029543
• Collaborator: The Gambia Committee on Traditional Practices Affecting the Health of Women and Children (GAMCOTRAP) (Other)
• Enrollment: 350
• Location: 1
• Anticipated Duration (Months): 36
• Patients Per Site Per Month: 9.7

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
COPD; Lung Function Decreased; Alpha 1-Antitrypsin

Study Design

• Study Type: Observational [Patient Registry]
• Anticipated Enrollment: 350 participants
• Observational Model: Ecologic or Community
• Time Perspective: Cross-Sectional
• Official Title: Permian Health Women's Lung Health Study
• Anticipated Study Start Date: Dec 1, 2023
• Anticipated Primary Completion Date: Dec 1, 2026
• Anticipated Study Completion Date: Dec 1, 2026

Arms and Interventions

Arm	Intervention/Treatment
Gambian Women Gambian women aged 15 and older with lung function impairment as measured by spirometry

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 15 Years and Older
• Sexes Eligible for Study: Female
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Gamcotrap	Kanifing		Gambia

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

• Responsible Party: Permian Health Lung Institute
• ClinicalTrials.gov Identifier: NCT06029543
• Other Study ID Numbers: WLHS2023001
• First Posted: Sep 8, 2023
• Last Update Posted: Sep 8, 2023
• Last Verified: Aug 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Alpha 1-Antitrypsin Deficiency

Study Results

No Results Posted as of Sep 8, 2023