Permian Health Women's Lung Health Study

NCT06029543 | Not Yet Recruiting

• 1 other identifier: WLHS2023001
• Study Type: observational
• Target: 350
• Locations: 1 country
• Sites: 1

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

Conditions

COPD; Lung Function Decreased; Alpha 1-Antitrypsin

Outcome Measures

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.

  Through study completion, an average of 1 year

Secondary Outcomes (1)

• Prevalence of Type II (Eosinophilic) inflammation in Gambian Women

  Through study completion, an average of 1 year

Study Arms (1)

Gambian Women

Gambian women aged 15 and older with lung function impairment as measured by spirometry

Eligibility Criteria

• Age: 15 Years+
• Gender Eligibility Details: Self-identified female sex
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All women older than 15 years in The Gambia

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Gamcotrap

Kanifing, The Gambia

Location

Related 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.

  PMID: 36185970 BACKGROUND

• 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.

  PMID: 14974740 BACKGROUND

• 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.

  PMID: 16611654 BACKGROUND

• 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.

  PMID: 16236846 BACKGROUND

• 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.

  PMID: 29430176 BACKGROUND

• 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.

  PMID: 14522813 BACKGROUND

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Respiratory Insufficiency; alpha 1-Antitrypsin Deficiency

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiration Disorders; Liver Diseases; Digestive System Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Subcutaneous Emphysema; Emphysema

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: CROSS SECTIONAL
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2023
• First Posted: September 8, 2023
• Study Start: December 1, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: September 8, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)