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Not yet recruiting NCT06029543

Permian Health Women's Lung Health Study

— Observational COPD Lung Function Decreased Alpha 1-Antitrypsin

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: COPD, Lung Function Decreased, Alpha 1-Antitrypsin. Basic parameters: from 15 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
The Gambia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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

Primary outcome measures

  • Prevalence of lung function Impairment as measured by spirometry [Time frame: Through study completion, an average of 1 year]
Secondary outcome measures (1)
  • Prevalence of Type II (Eosinophilic) inflammation in Gambian Women [Time frame: Through study completion, an average of 1 year]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Ecologic or community

Study locations

The Gambia · 1 center
  • Gamcotrap — Kanifing

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. PMID 36185970
  • 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
  • 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
  • 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
  • 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
  • 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

Identifiers

NCT: NCT06029543 · WLHS2023001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗