COPDWLHSNCT06029543
Permian Health Women's Lung Health Study
An observational study of COPD and Lung Function Decreased, run by Permian Health Lung Institute at 1 site in The Gambia.
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. Read more about this study
- Who is it for?
- Ages 15 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- COPD, Lung Function Decreased, Alpha 1-Antitrypsin
- How many people
- 350 participants
- Where
- 1 siteThe Gambia
- Study dates
- Dec 2023to Dec 2026
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: All women older than 15 years in The Gambia
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
The Gambia1 site
Gamcotrap
Kanifing
Musa D Jallow, +220-712-0569, musajah1979@yahoo.com
Adjoa K Hackman-Stevens, +220-219-4022, nanarays12@gmail.com
About this study
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
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Respiratory Insufficiency, alpha 1-Antitrypsin Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Gambian Women | Gambian women aged 15 and older with lung function impairment as measured by spirometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Through study completion, an average of 1 year
Secondary outcomes (1)
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.
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2023
- Study startDec 2023 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for COPDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 350 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Permian Health Lung Institute
- Sponsor type
- University, hospital or other
- Collaborators
- The Gambia Committee on Traditional Practices Affecting the Health of Women and Children (GAMCOTRAP)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06029543
- Sponsor's protocol ID
- WLHS2023001
- Acronym
- WLHS
- Status last verified
- Aug 2023
- First submitted
- 26 Aug 2023
- Last updated
- 8 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 36185970Chan-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.
PubMed 14974740Halbert 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.
PubMed 16611654Stoller 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.
PubMed 16236846Chapman 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.
PubMed 29430176American 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.
PubMed 14522813
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Permian Health Women's Lung Health Study
- ClinicalTrials.gov ID
- NCT06029543
- Acronym / sponsor ID
- WLHS / WLHS2023001
- Conditions
- COPD, Lung Function Decreased, Alpha 1-Antitrypsin
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Permian Health Lung InstituteUniversity, hospital or other
- Collaborators
- The Gambia Committee on Traditional Practices Affecting the Health of Women and Children (GAMCOTRAP)
- Study start
- Dec 2023 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 8 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Target follow-up
- 3 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gambian Women | – | –Gambian women aged 15 and older with lung function impairment as measured by spirometry |
Who may qualify
- Ages
- 15 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All women older than 15 years in The Gambia
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (6 listed)
- Age < 15 years
- Non-resident household member
- Any acutely unwell individual
- Pregnancy
- Any known history of active pulmonary disease (including TB) on treatment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prevalence of lung function Impairment as measured by spirometry
Time frame: 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.
1 secondary outcome
Prevalence of Type II (Eosinophilic) inflammation in Gambian Women
Time frame: Through study completion, an average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2023.
- Background: PubMed 36185970Ale 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.
- Background: PubMed 14974740Chan-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.
- Background: PubMed 16611654Halbert 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.
- Background: PubMed 16236846Stoller 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.
- Background: PubMed 29430176Chapman 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.
- Background: PubMed 14522813American 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COPD and Lung Function Decreased, run by Permian Health Lung Institute at 1 site in The Gambia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in The Gambia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of lung function Impairment as measured by spirometry (time frame: Through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06029543, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2023.