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COPDNCT05569005

Effect of Switching From Cigarette Smoking to THS on Disease Progression in Mild to Moderate COPD Subjects With Chronic Bronchitis Symptoms.

A study testing THS use, Cigarette and Smoking Abstinence in people with COPD and Smoking, run by Philip Morris Products S.A. at 170 sites in 8 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

The purpose of this study is to demonstrate the slowing of the disease progression including the improvement of Chronic Obstructive Pulmonary Disease (COPD) symptoms in smoking subjects with mild to moderate COPD and a history of chronic bronchitis symptoms (sputum and cough) who switch to the Tobacco Heating System… Read more about this study

Who is it for?
Ages 35 to 65 years
Conditions the study is for
COPD, Smoking, Tobacco Use
What is being tested?
THS use, Cigarette and Smoking Abstinence
Could I receive a placebo?
No, everyone receives an active treatment
How many people
715 participants
Where
170 sitesin 8 countries
Study dates
16 Dec 2022to 13 Sep 2024
Phase
Interventional
Are there results?
None posted in the registry

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 35 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Main Inclusion Criteria:

  • Subjects have read, understood, and signed the written informed consent form (ICF)
  • Diagnosis of COPD GOLD Stage 1 or 2 (FEV1/FVC <0.70 \& FEV1 ≥60% predicted [post-BD])
  • Current symptoms of chronic bronchitis (sputum and cough) based on CAT questionnaire scores for CAT1 (cough) item ≥ 3 and CAT2 (sputum) item ≥ 3
  • Body mass index (BMI) 17.6-40.0 kg/m2 and body weight > 50 kg (male) or 40 kg (female).
  • Subject has a smoking history of at least 10 years.
  • Subject has been smoking ≥ 10 commercially available cigarettes/day on average (no brand restriction) for at least 1 year prior to V1 (based on self-reporting).
  • Subject has not used other tobacco and nicotine products apart from cigarettes on a daily basis over the past year prior to V1.
  • For subjects not willing to quit smoking only: have been advised to quit smoking, informed of smoking risks and of cessation programs and is still not willing to quit during the study duration.
  • Subjects willing to quit smoking only: willing to set a target quit date (TQD) within the next 28 days at V1 as assessed by self-reported questions.

Main Exclusion Criteria:

  • Subjects with any (mild, moderate or severe) COPD exacerbation that has not resolved at least four weeks prior to V1
  • Subjects with active cancer or history of any cancer
  • Subjects with pneumonia or other lower respiratory tract infections that have not resolved at least four weeks prior to V1
  • Subjects with other active systemic infections that have not resolved at least 4 weeks prior to V1
  • Subjects with other active respiratory disorders such as, but not limited to, tuberculosis, bronchiectasis, sarcoidosis, asthma2, pulmonary hypertension, interstitial lung diseases (e.g., idiopathic pulmonary fibrosis [IPF]). No new examination is required if the subject can present at V1, at a minimum, a Chest XRay (CXR) (or Computed Tomography (CT) of the chest, if available) not older than 6 months with anterior-posterior and left lateral views
  • The subject is confirmed or suspected with active SARS-CoV-2 infection (as per site and per country recommendation)
  • Clinically significant ECG alterations that will not allow subject to participate in the study, per Investigator's discretion
  • Any concomitant disease that in the opinion of the investigator would interfere with the study procedures
  • Subjects with diagnosed alpha-1 antitrypsin deficiency (AATD)
  • History of alcohol and/or drug abuse which as per judgment of the Investigator would jeopardize either the participation in an investigational study or safety of the subject
  • Positive serology test (HIV 1/2, hepatitis B or C).
  • Inability to cooperate with the study procedures
  • Previous participation in this study, or participation in an investigational study (drug or medical device) within 4 weeks before V1 (participation in observational studies/registries allowed)
  • Close affiliation with the investigational site: a close relative of the investigator, a person dependent on the investigational site (e.g., employee or student of the investigational site)
  • Subject is a current or former employee of the tobacco industry or their first-degree relatives (parent, child, spouse)
  • Subjects have re-initiated smoking in the six months prior to V1
  • Subjects have used in the past 3 months, or are currently daily using THS
  • Any oral/injectable corticosteroids (acute or chronic treatments) or oxygen therapy in the last 2 months excluding short term use for a COPD exacerbation
  • Female subject is pregnant or breastfeeding, (a urine pregnancy test will be performed at V1 and V2)
  • For women of childbearing potential, female subject who does not agree to using an acceptable method of effective contraception during the entire study.

Trial locations and contacts

170 sites in 8 countries.

170 sites in 8 countries

United States81 sites

  • UX99; Accelerated Enrollment Solutions (AES)

    Atlanta, Georgia, 30328

  • US03; Inquest Clinical Research

    Baytown, Texas, 77521

  • UX20; Novel Research, LLC

    Bellaire, Texas, 77401

  • US49; Clinical Research of Brandon LLC

    Brandon, Florida, 33511

  • US97; Riverside Research Group

    Cape Coral, Florida, 33909

  • US38; Innovative Research Of West Florida, Inc.

    Clearwater, Florida, 33756

  • US81; Oracle Clinical Research

    College Park, Georgia, 30349

  • UX22; ClinCept, LLC

    Columbus, Georgia, 31904

  • US47; Hope Clinical Trials, Inc

    Coral Gables, Florida, 33134

  • US42; Houston Pulmonary and Sleep Associates

    Cypress, Texas, 77429

  • UX24; Alfa Medical Research

    Davie, Florida, 33024

  • US94; D & H Doral Research Center, LLC

    Doral, Florida, 33122

  • UX10; Unique Clinical Trials, LLC

    Doral, Florida, 33172

  • UX12; Solution Clinical Research

    Doral, Florida, 33178

  • US83; Proactive Clinical Research LLC

    Fort Lauderdale, Florida, 33308

  • UX01; 3Sync

    Fort Lauderdale, Florida, 33309

  • UX34; Mt.Olympus Medical Research

    Friendswood, Texas, 77546

  • US93; Finlay Medical Research

    Greenacres City, Florida, 33467

  • US70; Harmony Medical Research Institute, Inc.

    Hialeah, Florida, 33016

  • US68; Global Research Associates

    Homestead, Florida, 33030

  • US88; HDH Research Inc

    Houston, Texas, 77022

  • US73; Victorium Clinical Research

    Houston, Texas, 77024

  • US53; Alpha Research Institute, LLC

    Houston, Texas, 77036

  • US87; Biopharma Informatic Research Center

    Houston, Texas, 77043

  • UX14; Prolato Clinical Research Center

    Houston, Texas, 77054

  • UX09; Pioneer Research Solutions, Inc

    Houston, Texas, 77099

  • UX18; Accurate Clinical Research, Inc

    Humble, Texas, 77338

  • US01; Accel Research Sites-LKD CRU

    Lakeland, Florida, 33803

  • US25; Accel Research Sites

    Largo, Florida, 33777

  • US12; Leesburg Medical Research Institute, LLC

    Leesburg, Florida, 34748

  • US63; Lifeline Primary Care/CCT Research

    Lilburn, Georgia, 30047

  • US20; Accel Clinical Research

    Maitland, Florida, 32751

  • US39; Proactive Clinical Research, LLC (formerly Invesclinic, U.S. LLC)

    McAllen, Texas, 78503

  • US62; Metroplex Pulmonary And Sleep Medicine Center

    McKinney, Texas, 75069

  • UX16; Pioneer Research Solutions, Inc

    Mesquite, Texas, 75149

  • UX15; Med-Care Research Corp.

    Miami, Florida, 33125

  • US13; LCC Medical Research Institute, LLC

    Miami, Florida, 33126

  • US48; Ocean Clinical Research, LLC

    Miami, Florida, 33126

  • US80; Enmanuel Advance Research Center

    Miami, Florida, 33126

  • UX02; Finlay Medical Research

    Miami, Florida, 33126

  • US84; Global Health Clinical Trials

    Miami, Florida, 33135

  • US86; South Florida Research Center, Inc.

    Miami, Florida, 33135

  • US21; Bioclinical Research Alliance, Inc.

    Miami, Florida, 33155

  • US36; Allied Biomedical Research Institute

    Miami, Florida, 33155

  • US79; Cordova Research Institute, LLC

    Miami, Florida, 33155

  • US82; Florida International Medical Research

    Miami, Florida, 33155

  • UX25; D&H National Research Centers (Bird)

    Miami, Florida, 33155

  • US72; BioMed Research and Medical Center. LLC

    Miami, Florida, 33156

  • US55; American Research Institute

    Miami, Florida, 33157

  • US56; Medical Research of Westchester, Inc

    Miami, Florida, 33165

  • US95; Premier Research Associate, Inc

    Miami, Florida, 33165

  • UX06; Wellness Research Center Inc

    Miami, Florida, 33165

  • US37; Research Institute Of South Florida, Inc.

    Miami, Florida, 33173

  • US76; Reed Medical Research

    Miami, Florida, 33176

  • US91; Ambert Medical Research

    Miami, Florida, 33176

  • US90; Felicidad Medical Research

    Miami, Florida, 33184

  • US40; Clinical Trials of Florida, LLC

    Miami, Florida, 33186

  • UX07; Innovations Biotech

    Miami, Florida, 33186

  • UX11; United Research Group

    Miami, Florida, 33186

  • US43; San Marcus Research Clinic Inc

    Miami Lakes, Florida, 33014

  • US89; 3Sync Research - Hialeah

    Miami Lakes, Florida, 33014

  • US98; MedQuest Translational Sciences

    Miami Lakes, Florida, 33016

  • UX13; Synapse Clinical Research Inc.

    Missouri City, Texas, 77459

  • UX26; Harmony Clinical Research, Inc

    North Miami Beach, Florida, 33162

  • UX17; AES Orlando

    Orlando, Florida, 32806

  • US04; Omega Research Consultants

    Orlando, Florida, 32808

  • US10; Florida Institute for Clinical Research

    Orlando, Florida, 32825

  • US57; Innovation Medical Group LLC

    Palmetto Bay, Florida, 33157

  • US58; Bioresearch Institute LLC

    Pembroke Pines, Florida, 33026

  • US31; IACTHealth d/b/a Centricity Research

    Rincon, Georgia, 31326

  • US59; Pulmonary and Sleep Institute

    San Antonio, Texas, 78258

  • US41; Clinovation International Corp

    Sebring, Florida, 33870

  • US52; Sherman Clinical Research

    Sherman, Texas, 75092

  • UX21; R & H Clinical Research

    Stafford, Texas, 77477

  • UX08; TBC Research Corp.

    Tamarac, Florida, 33321

  • US50; Precision Research Center

    Tampa, Florida, 33614

  • UX04; Clinical Trials of Tampa

    Tampa, Florida, 33614

  • US74; Renovatio Clinical - The Woodlands Research Center

    The Woodlands, Texas, 77380

  • US46; Palm Beach Research Center

    West Palm Beach, Florida, 33409

  • US45; Clinical Site Partners, Inc. d/b/a CSP Orlando

    Winter Park, Florida, 32789

  • US45; Clinical Site Partners, LLC - Winter Park, Florida Premier Research Institute (FPRI)

    Winter Park, Florida, 32789

Other trials in United States

Bulgaria26 sites

  • BG30; MHAT Puls AD

    Blagoevgrad, 2700

  • BG28; MC Dr Staykov

    Burgas, 8000

  • BG03; Medical Center Asklepii OOD

    Dupnitsa, 2600

  • BG36; MHAT Sveti Ivan Rilski

    Dupnitsa, 2600

  • BG05; Medical Center Pulmo-2018 EOOD

    Haskovo, 6300

  • BG19; MC Zdrave 1

    Kozloduy, 3320

  • BG17; Diagnostic Consultative Center 1 - Lom EOOD

    Lom, 3600

  • BG07; Medical Center Leo Clinic

    Lovech, 5500

  • BG26; Medical Center Hera - Montana branch

    Montana, 3400

  • BG37; DCC (Diagnostic Consultative Center) 1 Pernik

    Pernik, 2306

  • BG32; Medconsult Pleven

    Pleven, 5800

  • BG40; Multiprofile Hospital for Active Treatment Trimontium

    Plovdiv, 4000

  • BG12; MHAT Sveti Panteleymon EOOD

    Plovdiv, 4004

  • BG08; Medical center Respiro

    Razgrad, 7200

  • BG27; Diagnostic Consultative Center 1- Sliven EOOD

    Sliven, 8800

  • BG29; MHAT Sliven to MMA Sofia

    Sliven, 8800

  • BG33; Diagnostic Consultative Centre Sliven

    Sliven, 8800

  • BG06; University First Multiprofile Hospital for Active treatment-Sofia EAD

    Sofia, 1142

  • BG31; Medical Center Hera EOOD

    Sofia, 1510

  • BG21; MC Preventsia 2000

    Stara Zagora, 6000

  • BG38; MHAT Prof. Stoyan Kirkovich

    Stara Zagora, 6000

  • BG01; Medical Center Zara EOOD

    Stara Zagora, 6003

  • BG16; Medical Centre Leo Clinic EOOD

    Varna, 9020

  • BG14; Medical Center Tara OOD

    Veliko Tarnovo, 5000

  • BG39; Specialized Hospital for Active Treatment of Pneumo-phthizilogic Diseases - Dr. Treiman - Dr. Treiman

    Veliko Tarnovo, 5000

  • BG22; SHATPPD Vratsa

    Vratsa, 3001

Other trials in Bulgaria

Germany17 sites

  • DE15; Emovis GmbH

    Berlin, 10629

  • De10; Rcms

    Berlin, 10717

  • DE21; Velocity Clinical Research Germany GmbH

    Berlin, 10787

  • DE19; Synexus Clinical Research GmbH

    Berlin, 12627

  • DE30; MECS Cottbus GmbH

    Cottbus, 3050

  • DE28; Klifeck GmbH

    Delitzsch, 4509

  • DE07; Klinische Forschung Dresden GmbH

    Dresden, 1069

  • DE26; Synexus Clinical Research GmbH

    Frankfurt, 60313

  • DE06; Klinische Forschung Hamburg GmbH

    Hamburg, 20253

  • DE03; Klinische Forschung Hannover-Mitte GmbH

    Hanover, 30159

  • DE01; Leipzig Research Centre-Synexus Clinical Research GmbH

    Leipzig, 4103

  • DE04; Facharzt fur Innere Medizin und Pneumologie

    Leipzig, 4157

  • DE12; Studienzentrum FMZ

    Leipzig, 4179

  • DE17; Klinische Forschung Berlin-Mitte

    Mitte, 10117

  • DE27; Centrum fuer Diagnostik und Gesundheit (CDG)

    Munich, 80809

  • DE25; Gemeinschaftspraxis Dres. Holger Kittner und Kerstin Hartig

    Naunhof, 4683

  • DE14; Studienzentrum Dr.med.Schlenska

    Peine, 31224

Other trials in Germany

Czechia13 sites

  • CZ05; Ordinace Hradebni s.r.o.

    České Budějovice, 37001

  • CZ09; Plicni ambulance Kralupy, s.r.o.

    Kralupy nad Vltavou, 27801

  • CZ07; MUDr. Jakub Strincl s.r.o.

    Liberec, 460 14

  • CZ10; Nemocnice Mesice

    Měšice, 25064

  • CZ17; Ordinace Pro Tbc a Respiracni Nemoci s.r.o

    Olomouc, 77200

  • CZ06; PreventaMed, s.r.o.

    Olomouc, 779 00

  • CZ02; Clinitrial, s.r.o.

    Prague, 100 00

  • CZ16; Synexus Czech, s.r.o

    Prague, 120 00

  • CZ03; Praglandia s.r.o.

    Prague, 150 00

  • CZ08; Medison s.r.o.

    Přeštice, 33401

  • CZ04; Zdravi-fit, s.r.o.

    Protivín, 398 11

  • CZ12; Ordinace pro TBC a Respiracni Nemoci - Strakonice

    Strakonice, 386 01

  • CZ01; Progerint s.r.o.

    Vysoké Mýto, 56601

Other trials in Czechia

Japan12 sites

  • JP03; Tokyo-Eki Center

    Chuo-Ku, Tokyo, 103-0027

  • JP01; Fukuwa Clinic

    Chuo-Ku, Tokyo, 104-0031

  • JP05; Tashiro Endocrinology Clinic

    Fukuoka, Fukuoka, 814-0153

  • JP02; P-one Clinic

    Hachioji-shi, Tokyo, 192-0071

  • JP14; Sawada Clinic

    Himeji-Shi, Hyōgo, 670-0942

  • JP11; Haruta Respiratory Clinic

    Hiroshima, Hiroshima, 730-0853

  • JP08; Uchiyama Clinic

    Jōetsu, Niigata, 949-3443

  • JP09; Takahashi Internal Medicine

    Kawasaki, Kanagawa, 211-0041

  • JP12; Takahashi Internal Medicine and Respiratory Clinic

    Obihiro-shi, Hokkaido, 080-0013

  • JP10; Yamagata Clinic (Goto-J Respiratory and Allergy Clinic)

    Ōita, Oita Prefecture, 870-0921

  • JP06; Higashi Shinjuku Clinic

    Shinjuku-ku, Tokyo, 169-0072

  • JP04; Sanyudo Hospital

    Yonezawa-shi, Yamagata, 992-0045

Other trials in Japan

Slovakia11 sites

  • SK04; DIVERSITAS s.r.o. - Hlohovec vseobecne

    Hlohovec, 92001

  • SK08; IRS - Medicínska cinnost s.r.o.

    Košice, 4001

  • SK01; PANACEUM s.r.o.

    Košice, 4011

  • SK02; MEDI M&M s.r.o.

    Moldava nad Bodvou, 045 01

  • SK07; Hodosi-MED s.r.o.

    Moldava nad Bodvou, 045 01

  • SK05; MEDIPA, s.r.o., Vseobecna ambulancia pre dospelych

    Piešťany, 92101

  • SK12; PULMO s.r.o.

    Prešov, 8001

  • SK06; MUDr. Viliam Cibik, Phd, s.r.o.

    Pruské, 018 52

  • SK10; Plucna ambulancia Hrebenar s.r.o.

    Spišská Nová Ves, 052 01

  • SK09; Aquilamed s. r. o.

    Štiavnik, 1355

  • SK03; Alergia, s.r.o.

    Topoľčany, 955 01

Other trials in Slovakia

United Kingdom7 sites

  • GB03; Accellacare Northamptonshire

    Corby, Northamptonshire, NN18 9EZ

  • GB02; Accellacare Warwickshire

    Coventry, West Midlands, CV3 4FJ

  • GB07; Egin Research Ltd

    High Wycombe, Buckinghamshire, HP11 2QW

  • GB06; Velocity Clinical Research North London

    North Finchley, London, N12 8BU

  • GB04; Accellacare North London

    Northwood, Middlesex, HA6 2RN

  • GB05; Accellacare South London

    Orpington, Kent, BR5 3QG

  • GB01; Accellacare Yorkshire

    Shipley, Yorkshire, BD18 3SA

Other trials in United Kingdom

Romania3 sites

  • RO05; Centrul Medical de Diagnostic si Tratament Ambulatoriu Neomed SRL

    Brasov, 500283

  • RO04; Sc Sana Monitoring Srl

    Bucharest, 11025

  • RO06; Sc Ames Research Srl

    Calarasi, 910103

Other trials in Romania

About this study

Official title: A 3-year, 3-group, Preference, Multi-center Study to Demonstrate the Slowing of Disease Progression When Switching From Cigarette Smoking to the Tobacco Heating System (THS) in Mild to Moderate Chronic Obstructive Pulmonary Disease (COPD) Subjects With a History of Chronic Bronchitis Symptoms.

The purpose of this study is to demonstrate the slowing of the disease progression including the improvement of Chronic Obstructive Pulmonary Disease (COPD) symptoms in smoking subjects with mild to moderate COPD and a history of chronic bronchitis symptoms (sputum and cough) who switch to the Tobacco Heating System (THS) as compared to those who continue to smoke cigarettes.

Read the detailed description

This study will be a multiregional (Europe, U.S., and Asia) multi-center, open-label study with 3-group, parallel preference design (Cigarette, THS use, and Smoking Abstinence).

Subjects will self-select their group allocation according to their preference. Subjects who would like to quit cigarettes or THS during the study will be encouraged to do so and will be referred to appropriate services.

The study will be declared successful if a slowing of the disease progression is demonstrated with the primary objective endpoint of forced expiratory volume in the first second (FEV1) post-bronchodilator at Month 36 or if an improvement of COPD symptoms (COPD Assessment Test total score at interim analysis at Month 12) is demonstrated.

Being tested
THS use, Cigarette, Smoking Abstinence
Medical subject headings
Pulmonary Disease, Chronic Obstructive, Smoking, Tobacco Use

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • THS useOther

    Also called Tobacco Heating System 3.0

    Subjects who are not willing to quit smoking during the study duration will switch from cigarettes to using THS

  • CigaretteOther

    Subjects who are not willing to quit smoking during the study duration will continue smoking their own preferred brand of commercially available cigarettes.

  • Smoking AbstinenceOther

    Subjects who are willing to quit smoking may be prescribed an NRT to support them in remaining abstinent from use of any tobacco and nicotine containing products during the study. (Behavioral support will be provided to subjects to aid with abstinence.)

Study groups in NCT05569005
Study groupRoleWhat they receive
THSActive comparatorSubjects who are not willing to quit smoking.
Receives: Other: THS use
CigaretteActive comparatorSubjects who are not willing to quit smoking.
Receives: Other: Cigarette
Smoking AbstinenceActive comparatorSubjects who are willing to quit smoking.
Receives: Other: Smoking Abstinence

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Disease Progression

    Disease progression will be assessed by measuring Forced Expiratory Volume in 1 second (FEV1), post-bronchodilator

    Measured: At month 36

  2. COPD symptoms

    COPD symptoms will be assessed from the total score of the COPD Assessment Test (CAT).

    Measured: At month 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Oct 2022
  2. Study start16 Dec 2022
  3. Primary completion13 Sep 2024
  4. Study completion13 Sep 2024

Why it stopped: The study team decided to terminate the study due to operational infeasibility caused by challenges with recruiting the necessary number of participants.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
A multiregional (Europe, U.S. and Asia) multi-center, open-label study with 3-group, parallel preference design (Cigarette, THS use and Smoking Abstinence).
Masking
None (open label)
Enrolment
715 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05569005
Sponsor's protocol ID
P1-COPD-04-INT
Status last verified
Sep 2024
First submitted
30 Sep 2022
Last updated
26 Sep 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing THS use, Cigarette and Smoking Abstinence in people with COPD and Smoking, run by Philip Morris Products S.A. at 170 sites in 8 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

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: stopped early, as of the sponsor's last update on 26 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 170 sites in United States, Bulgaria, Germany, Czechia, Japan and 3 more countries. 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?

The study was stopped early (reason given: The study team decided to terminate the study due to operational infeasibility caused by challenges with recruiting the necessary number of participants.). Results are not available in the source record.

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?

Disease Progression (time frame: At month 36). The study lists 2 primary outcomes in all. 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 NCT05569005.

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 26 Sep 2024.

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