Pulmonary Disease, Chronic ObstructiveNCT06844175
Early Screening of Young COPD and Pre-COPD
An observational study of Pulmonary Disease, Chronic Obstructive, run by yanmengkang.
Trial summary
At present, patients with early COPD and pre-COPD have not been paid attention to in clinical work. This study aims to actively screen such patients in high-risk groups to clarify their prevalence, monitor and analyze relevant clinical and biological indicators, and find sensitive indicators to assist in early… Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- What is being tested?
- Budesonide, Glycopyrronium Bromide and Formoterol Fumarate Inhalation Aerosol
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2025to 30 Dec 2026
- 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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: early chronic obstructive pulmonary disease: age \< 50 years of age with at least 10 pack-years of smoking history and one of the following: FEV1/FVC\< 0.7, abnormal computer tomography (CT) and a decline in FEV1 of at least 60mL/ year. Precopd (emphysema type) : Involves individuals of any age who have respiratory symptoms, with or without structural (radiographic emphysema) and/or functional abnormalities, no airflow limitation (FEV1/FVC≥0.70), and may develop persistent airflow limitation over time.
Who may be able to join
- 1. Age 20-70 years old; 2. smoking history ≥10 pack-years or presence of visually visible emphysema on low-dose CT scan; 3. Able to tolerate or cooperate with pulmonary function test; ④4.able to understand the study and sign the relevant informed consent.
Who cannot join
- 1.History of acute or chronic respiratory diseases other than COPD, including interstitial lung disease, bronchiectasis, pulmonary infection, tumor, or lung surgery; 2.patients previously diagnosed with clinical COPD; 3.Severe liver and kidney dysfunction; 4.serious heart failure or malignant arrhythmia; 5.acute cerebrovascular events within the past 3 months; 6.malignant tumor without cure; 7.the history of mental illness; 8.breastfeeding, pregnancy or planned pregnancy; 9.Subjects who are expected to be unable to cooperate and follow up.
About this study
Official title: A Prospective, Multicenter Cohort Study of Multidimensional Screening and Triple Drug Intervention in Young Patients with Chronic Obstructive Pulmonary Disease and Pre-chronic Obstructive Pulmonary Disease
At present, patients with early COPD and pre-COPD have not been paid attention to in clinical work. This study aims to actively screen such patients in high-risk groups to clarify their prevalence, monitor and analyze relevant clinical and biological indicators, and find sensitive indicators to assist in early diagnosis. Based on the updated definition of COPD in GOLD2022, we pay attention to the concept of early COPD and pre-COPD. After the completion of patient enrollment and data collection, we will further explore the effect of triple inhaled drug intervention on the development of lung function in patients with early COPD and pre-COPD, so as to provide clinical support for early screening and early treatment of COPD.
- Patients with early COPD and pre-COPD were selected from 20 hospitals in 17 cities of Shandong province to understand the prevalence and basic characteristics of such diseases in the province, and then were divided into groups and treated.
- The specificity and sensitivity of pulmonary function parameters (FEV1%,FEV1/FVC, DLco, etc.) and imaging parameters (MLD, Perc15, %LAA-950HU, etc.) alone or in combination in the diagnosis of early COPD and pre-COPD, and the predictive diagnostic model/system was established.
- Treatment of early COPD and pre-COPD: eligible patients were given triple inhalation therapy or placebo, and the effects of triple inhalation therapy or not on clinical symptoms, pulmonary function, and imaging parameters were compared.
This study aims to determine the prevalence of early COPD in Shandong province and provide a reference for the treatment of this population.
Read the detailed description
- Basic information and related definitions: The basic information included age, gender, body mass index (BMI), smoking status (smoking index, passive smoking), biomass exposure, occupational exposure history of dust/gas/smoke, and family history of respiratory diseases. Participants' smoking status was categorized as never smoked, former smoker, or current smoker. Never smoked was defined as having smoked fewer than 100 cigarettes in the past. Current smoking was defined as baseline smoking. Previous smoking was defined as having smoked more than 100 cigarettes previously but not smoking for at least 6 months before baseline. The smoking index was defined as the number of packs of cigarettes smoked per day multiplied by the number of years smoked. Passive smoking was defined as smoke inhalation by non-smokers living with smokers for more than 1 year. Biomass exposure was defined as the use of biomass such as wood, crop residue, charcoal, grass, and manure for more than 1 year. Exposure to occupational dust/gas/smoke was defined as occupational exposure to dust/gas/smoke for more than 1 year during the lifetime of the subject. Family history of respiratory disease was defined as respiratory disease in parents, siblings, and childhood (e.g., chronic bronchitis, emphysema, asthma, COPD, cor pulmonalis, bronchiectasis, lung cancer, interstitial lung disease, obstructive sleep apnea-hypopnea syndrome) and a further visit to assess medication use history. Clinical symptoms included cough, expectoration, shortness of breath after exercise, suffocating wheezing, and dyspnea. Clinical symptoms were defined as the above symptoms not caused by other clear causes, and the cumulative time was not less than 2 months per year.
- Questionnaire scores: ① Modified dyspnea scale (mMRC) : mainly used to evaluate the degree of dyspnea in COPD patients. The scale ranges from 0 to 4, with higher grades indicating more severe dyspnea, with grades 1 and 2 indicating "mild-to-moderate dyspnea," and grades 3 and 4 indicating "severe to very severe dyspnea. ②CAT score: a total of 8 questions covering symptoms, activities and conditions. Each question corresponds to a 0-5 point option on a 40-point scale, with higher scores indicating worse health status.
- Pulmonary function: it was determined that the enrolled patients should stop using drugs that affect the test results and avoid related influencing factors before bronchodilation. Professional staff guided the patients to carry out respiratory training, and completed pulmonary ventilation and diffusion function tests. Ventilatory function was measured before and 15 minutes after inhalation of a bronchodilator (albuterol). forced vital capacity (FVC) and its percentage of predicted value (FVC%pred), forced expiratory volume in one second (FEV1) were recorded accurately. FEV1) and its percentage of predicted value (FEV1%pred), FEV1/FVC, maximum minute ventilation volume (MVV) and its percentage of predicted value (MVV%pred). The maximum midexpiratory flow (MMEF) was calculated. Diffusion capacity (DLCO) was measured by taking four to five quiet breaths in a single breath, then exhaling deeply to RV position, inhaling quickly to TLC position, holding breath for 10 seconds, and exhaling all the gas to RV position. (3) Pulmonary function: it was determined that the enrolled patients should stop using drugs that affect the test results and avoid related influencing factors before bronchodilation. Professional staff guided the patients to carry out respiratory training, and completed pulmonary ventilation and diffusion function tests. Ventilatory function was measured before and 15 minutes after inhalation of a bronchodilator (albuterol). forced vital capacity (FVC) and its percentage of predicted value (FVC%pred), forced expiratory volume in one second (FEV1) were recorded accurately. FEV1) and its percentage of predicted value (FEV1%pred), FEV1/FVC, maximum minute ventilation volume (MVV) and its percentage of predicted value (MVV%pred). The maximum midexpiratory flow (MMEF) was calculated. Diffusion capacity (DLCO) was measured by taking four to five quiet breaths in a single breath, then exhaling deeply to RV position, inhaling quickly to TLC position, holding breath for 10 seconds, and exhaling all the gas to RV position. (5) Six-minute walk test: The enrolled patients were performed on a flat, straight corridor with a length of 30 meters. They avoided strenuous activities within 2 hours before the test and could carry a cane or walking aid to the test. Blood pressure, pulse, and oxygen saturation were measured. Then the subjects were asked to walk as much as possible along the established route within six minutes. If they felt tired, they could slow down or rest in place and continue walking as soon as possible. At the end of the six minutes, the subjects were allowed to stay in place, and their blood pressure, pulse, and oxygen saturation were rapidly measured again, and their total distance walked was recorded.
Objects and methods of intervention According to the results of pulmonary function test, patients diagnosed as early COPD or pre-COPD were given triple bronchial inhalation therapy according to the principle of voluntary, and professional staff were arranged to explain relevant knowledge, answer questions and guide medication. Each patient was asked to record medication use.
Follow-up time and endpoint indicators The patients were followed up for 1 year from the date of enrollment. The clinical symptoms, pulmonary function parameters, and imaging parameters of early COPD and pre-COPD patients with or without triple bronchial inhalation drug use were recorded, focusing on the annual decline in FEV1% pred, FEV1/FVC and DLCO.
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- Budesonide, Glycopyrronium Bromide and Formoterol Fumarate Inhalation Aerosol
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Budesonide, Glycopyrronium Bromide and Formoterol Fumarate Inhalation AerosolDrug
Also called placebo
The intervention group was given budigfovir once a day, the dose was 160ug/7.2ug/4.8ug by inhalation
| Study group | Role | What they receive |
|---|---|---|
| early COPD with placebo | 1. Age <50 years of age with at least 10 pack-years of smoking history and one of the following: FEV1/FVC\< 0.7, abnormal computer tomography (CT) and a decline in FEV1 of at least 60mL/ year. 2. Treatment with Placebo | |
| early COPD with triple inhalation therapy | 1. Age <50 years of age with at least 10 pack-years of smoking history and one of the following: FEV1/FVC\< 0.7, abnormal computer tomography (CT) and a decline in FEV1 of at least 60mL/ year.
2. Treatment with triple inhalation therapy Receives: Drug: Budesonide, Glycopyrronium Bromide and Formoterol Fumarate Inhalation Aerosol | |
| pre-COPD with placebo | 1. It involved individuals of any age who had respiratory symptoms with or without structural (imaging-suggested emphysema) and/or functional abnormalities, without airflow limitation (FEV1/FVC≥0.70), and who may develop persistent airflow limitation over time. 2. Treatment with Placebo | |
| pre-COPD with triple inhalation therapy | 1. It involved individuals of any age who had respiratory symptoms with or without structural (imaging-suggested emphysema) and/or functional abnormalities, without airflow limitation (FEV1/FVC≥0.70), and who may develop persistent airflow limitation over time.
2. Treatment with triple inhalation therapy Receives: Drug: Budesonide, Glycopyrronium Bromide and Formoterol Fumarate Inhalation Aerosol |
What is being measured
The primary outcome is the main question the study is designed to answer.
FEV1% and FEV1/FVC
After one year of follow-up, FEV1% and FEV1/FVC, DLco and other indicators were observed to decrease
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2025
- Study start1 Mar 2025 (estimated)
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- yanmengkang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, yanmengkang, Qianfoshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06844175
- Sponsor's protocol ID
- yanmeng kang
- Status last verified
- Dec 2024
- First submitted
- 19 Feb 2025
- Last updated
- 25 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter Cohort Study of Multidimensional Screening and Triple Drug Intervention in Young Patients with Chronic Obstructive Pulmonary Disease and Pre-chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT06844175
- Acronym / sponsor ID
- yanmeng kang
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- yanmengkangUniversity, hospital or other
- Study start
- 1 Mar 2025 (estimated)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 25 Feb 2025 (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.
At present, patients with early COPD and pre-COPD have not been paid attention to in clinical work. This study aims to actively screen such patients in high-risk groups to clarify their prevalence, monitor and analyze relevant clinical and biological indicators, and find sensitive indicators to assist in early diagnosis. Based on the updated definition of COPD in GOLD2022, we pay attention to the concept of early COPD and pre-COPD. After the completion of patient enrollment and data collection, we will further explore the effect of triple inhaled drug intervention on the development of lung function in patients with early COPD and pre-COPD, so as to provide clinical support for early screening and early treatment of COPD.
- Patients with early COPD and pre-COPD were selected from 20 hospitals in 17 cities of Shandong province to understand the prevalence and basic characteristics of such diseases in the province, and then were divided into groups and treated.
- The specificity and sensitivity of pulmonary function parameters (FEV1%,FEV1/FVC, DLco, etc.) and imaging parameters (MLD, Perc15, %LAA-950HU, etc.) alone or in combination in the diagnosis of early COPD and pre-COPD, and the predictive diagnostic model/system was established.
- Treatment of early COPD and pre-COPD: eligible patients were given triple inhalation therapy or placebo, and the effects of triple inhalation therapy or not on clinical symptoms, pulmonary function, and imaging parameters were compared.
This study aims to determine the prevalence of early COPD in Shandong province and provide a reference for the treatment of this population.
Detailed description
- Basic information and related definitions: The basic information included age, gender, body mass index (BMI), smoking status (smoking index, passive smoking), biomass exposure, occupational exposure history of dust/gas/smoke, and family history of respiratory diseases. Participants' smoking status was categorized as never smoked, former smoker, or current smoker. Never smoked was defined as having smoked fewer than 100 cigarettes in the past. Current smoking was defined as baseline smoking. Previous smoking was defined as having smoked more than 100 cigarettes previously but not smoking for at least 6 months before baseline. The smoking index was defined as the number of packs of cigarettes smoked per day multiplied by the number of years smoked. Passive smoking was defined as smoke inhalation by non-smokers living with smokers for more than 1 year. Biomass exposure was defined as the use of biomass such as wood, crop residue, charcoal, grass, and manure for more than 1 year. Exposure to occupational dust/gas/smoke was defined as occupational exposure to dust/gas/smoke for more than 1 year during the lifetime of the subject. Family history of respiratory disease was defined as respiratory disease in parents, siblings, and childhood (e.g., chronic bronchitis, emphysema, asthma, COPD, cor pulmonalis, bronchiectasis, lung cancer, interstitial lung disease, obstructive sleep apnea-hypopnea syndrome) and a further visit to assess medication use history. Clinical symptoms included cough, expectoration, shortness of breath after exercise, suffocating wheezing, and dyspnea. Clinical symptoms were defined as the above symptoms not caused by other clear causes, and the cumulative time was not less than 2 months per year.
- Questionnaire scores: ① Modified dyspnea scale (mMRC) : mainly used to evaluate the degree of dyspnea in COPD patients. The scale ranges from 0 to 4, with higher grades indicating more severe dyspnea, with grades 1 and 2 indicating "mild-to-moderate dyspnea," and grades 3 and 4 indicating "severe to very severe dyspnea. ②CAT score: a total of 8 questions covering symptoms, activities and conditions. Each question corresponds to a 0-5 point option on a 40-point scale, with higher scores indicating worse health status.
- Pulmonary function: it was determined that the enrolled patients should stop using drugs that affect the test results and avoid related influencing factors before bronchodilation. Professional staff guided the patients to carry out respiratory training, and completed pulmonary ventilation and diffusion function tests. Ventilatory function was measured before and 15 minutes after inhalation of a bronchodilator (albuterol). forced vital capacity (FVC) and its percentage of predicted value (FVC%pred), forced expiratory volume in one second (FEV1) were recorded accurately. FEV1) and its percentage of predicted value (FEV1%pred), FEV1/FVC, maximum minute ventilation volume (MVV) and its percentage of predicted value (MVV%pred). The maximum midexpiratory flow (MMEF) was calculated. Diffusion capacity (DLCO) was measured by taking four to five quiet breaths in a single breath, then exhaling deeply to RV position, inhaling quickly to TLC position, holding breath for 10 seconds, and exhaling all the gas to RV position. (3) Pulmonary function: it was determined that the enrolled patients should stop using drugs that affect the test results and avoid related influencing factors before bronchodilation. Professional staff guided the patients to carry out respiratory training, and completed pulmonary ventilation and diffusion function tests. Ventilatory function was measured before and 15 minutes after inhalation of a bronchodilator (albuterol). forced vital capacity (FVC) and its percentage of predicted value (FVC%pred), forced expiratory volume in one second (FEV1) were recorded accurately. FEV1) and its percentage of predicted value (FEV1%pred), FEV1/FVC, maximum minute ventilation volume (MVV) and its percentage of predicted value (MVV%pred). The maximum midexpiratory flow (MMEF) was calculated. Diffusion capacity (DLCO) was measured by taking four to five quiet breaths in a single breath, then exhaling deeply to RV position, inhaling quickly to TLC position, holding breath for 10 seconds, and exhaling all the gas to RV position. (5) Six-minute walk test: The enrolled patients were performed on a flat, straight corridor with a length of 30 meters. They avoided strenuous activities within 2 hours before the test and could carry a cane or walking aid to the test. Blood pressure, pulse, and oxygen saturation were measured. Then the subjects were asked to walk as much as possible along the established route within six minutes. If they felt tired, they could slow down or rest in place and continue walking as soon as possible. At the end of the six minutes, the subjects were allowed to stay in place, and their blood pressure, pulse, and oxygen saturation were rapidly measured again, and their total distance walked was recorded.
Objects and methods of intervention According to the results of pulmonary function test, patients diagnosed as early COPD or pre-COPD were given triple bronchial inhalation therapy according to the principle of voluntary, and professional staff were arranged to explain relevant knowledge, answer questions and guide medication. Each patient was asked to record medication use.
Follow-up time and endpoint indicators The patients were followed up for 1 year from the date of enrollment. The clinical symptoms, pulmonary function parameters, and imaging parameters of early COPD and pre-COPD patients with or without triple bronchial inhalation drug use were recorded, focusing on the annual decline in FEV1% pred, FEV1/FVC and DLCO.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| early COPD with placebo | – | –1. Age <50 years of age with at least 10 pack-years of smoking history and one of the following: FEV1/FVC\< 0.7, abnormal computer tomography (CT) and a decline in FEV1 of at least 60mL/ year. 2. Treatment with Placebo |
| early COPD with triple inhalation therapy | – | Drug: Budesonide, Glycopyrronium Bromide and Formoterol Fumarate Inhalation Aerosol1. Age <50 years of age with at least 10 pack-years of smoking history and one of the following: FEV1/FVC\< 0.7, abnormal computer tomography (CT) and a decline in FEV1 of at least 60mL/ year. 2. Treatment with triple inhalation therapy |
| pre-COPD with placebo | – | –1. It involved individuals of any age who had respiratory symptoms with or without structural (imaging-suggested emphysema) and/or functional abnormalities, without airflow limitation (FEV1/FVC≥0.70), and who may develop persistent airflow limitation over time. 2. Treatment with Placebo |
| pre-COPD with triple inhalation therapy | – | Drug: Budesonide, Glycopyrronium Bromide and Formoterol Fumarate Inhalation Aerosol1. It involved individuals of any age who had respiratory symptoms with or without structural (imaging-suggested emphysema) and/or functional abnormalities, without airflow limitation (FEV1/FVC≥0.70), and who may develop persistent airflow limitation over time. 2. Treatment with triple inhalation therapy |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- early chronic obstructive pulmonary disease: age \< 50 years of age with at least 10 pack-years of smoking history and one of the following: FEV1/FVC\< 0.7, abnormal computer tomography (CT) and a decline in FEV1 of at least 60mL/ year. Precopd (emphysema type) : Involves individuals of any age who have respiratory symptoms, with or without structural (radiographic emphysema) and/or functional abnormalities, no airflow limitation (FEV1/FVC≥0.70), and may develop persistent airflow limitation over time.
Key inclusion criteria (1 listed)
- 1. Age 20-70 years old; 2. smoking history ≥10 pack-years or presence of visually visible emphysema on low-dose CT scan; 3. Able to tolerate or cooperate with pulmonary function test; ④4.able to understand the study and sign the relevant informed consent.
Key exclusion criteria (1 listed)
- 1.History of acute or chronic respiratory diseases other than COPD, including interstitial lung disease, bronchiectasis, pulmonary infection, tumor, or lung surgery; 2.patients previously diagnosed with clinical COPD; 3.Severe liver and kidney dysfunction; 4.serious heart failure or malignant arrhythmia; 5.acute cerebrovascular events within the past 3 months; 6.malignant tumor without cure; 7.the history of mental illness; 8.breastfeeding, pregnancy or planned pregnancy; 9.Subjects who are expected to be unable to cooperate and follow up.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Budesonide, Glycopyrronium Bromide and Formoterol Fumarate Inhalation AerosolAlso: placeboThe intervention group was given budigfovir once a day, the dose was 160ug/7.2ug/4.8ug by inhalation | Drug | early COPD with triple inhalation therapy, pre-COPD with triple inhalation therapy |
Primary outcome
FEV1% and FEV1/FVC
Time frame: 1 year
After one year of follow-up, FEV1% and FEV1/FVC, DLco and other indicators were observed to decrease
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 25 Feb 2025.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Disease, Chronic Obstructive, run by yanmengkang.
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 1 inclusion and 1 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 25 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
FEV1% and FEV1/FVC (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Feb 2025.