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

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.

Study Overview

• Status: Terminated
• Conditions: Smoking; Tobacco Use; COPD
• Intervention / Treatment: Other: THS use; Other: Cigarette; Other: Smoking Abstinence

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.

• Study Type: Interventional
• Enrollment (Actual): 715
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Bulgaria
  • Blagoevgrad, Bulgaria, 2700
    • BG30; MHAT Puls AD
  • Burgas, Bulgaria, 8000
    • BG28; MC Dr Staykov
  • Dupnitsa, Bulgaria, 2600
    • BG03; Medical Center Asklepii OOD
  • Dupnitsa, Bulgaria, 2600
    • BG36; MHAT Sveti Ivan Rilski
  • Haskovo, Bulgaria, 6300
    • BG05; Medical Center Pulmo-2018 EOOD
  • Kozloduy, Bulgaria, 3320
    • BG19; MC Zdrave 1
  • Lom, Bulgaria, 3600
    • BG17; Diagnostic Consultative Center 1 - Lom EOOD
  • Lovech, Bulgaria, 5500
    • BG07; Medical Center Leo Clinic
  • Montana, Bulgaria, 3400
    • BG26; Medical Center Hera - Montana branch
  • Pernik, Bulgaria, 2306
    • BG37; DCC (Diagnostic Consultative Center) 1 Pernik
  • Pleven, Bulgaria, 5800
    • BG32; Medconsult Pleven
  • Plovdiv, Bulgaria, 4000
    • BG40; Multiprofile Hospital for Active Treatment Trimontium
  • Plovdiv, Bulgaria, 4004
    • BG12; MHAT Sveti Panteleymon EOOD
  • Razgrad, Bulgaria, 7200
    • BG08; Medical center Respiro
  • Sliven, Bulgaria, 8800
    • BG27; Diagnostic Consultative Center 1- Sliven EOOD
  • Sliven, Bulgaria, 8800
    • BG29; MHAT Sliven to MMA Sofia
  • Sliven, Bulgaria, 8800
    • BG33; Diagnostic Consultative Centre Sliven
  • Sofia, Bulgaria, 1142
    • BG06; University First Multiprofile Hospital for Active treatment-Sofia EAD
  • Sofia, Bulgaria, 1510
    • BG31; Medical Center Hera EOOD
  • Stara Zagora, Bulgaria, 6000
    • BG21; MC Preventsia 2000
  • Stara Zagora, Bulgaria, 6000
    • BG38; MHAT Prof. Stoyan Kirkovich
  • Stara Zagora, Bulgaria, 6003
    • BG01; Medical Center Zara EOOD
  • Varna, Bulgaria, 9020
    • BG16; Medical Centre Leo Clinic EOOD
  • Veliko Tarnovo, Bulgaria, 5000
    • BG14; Medical Center Tara OOD
  • Veliko Tarnovo, Bulgaria, 5000
    • BG39; Specialized Hospital for Active Treatment of Pneumo-phthizilogic Diseases - Dr. Treiman - Dr. Treiman
  • Vratsa, Bulgaria, 3001
    • BG22; SHATPPD Vratsa
• Czechia
  • Ceske Budejovice, Czechia, 37001
    • CZ05; Ordinace Hradebni s.r.o.
  • Kralupy Nad Vltavou, Czechia, 27801
    • CZ09; Plicni ambulance Kralupy, s.r.o.
  • Liberec, Czechia, 460 14
    • CZ07; MUDr. Jakub Strincl s.r.o.
  • Mesice, Czechia, 25064
    • CZ10; Nemocnice Mesice
  • Olomouc, Czechia, 77200
    • CZ17; Ordinace Pro Tbc a Respiracni Nemoci s.r.o
  • Olomouc, Czechia, 779 00
    • CZ06; PreventaMed, s.r.o.
  • Prague, Czechia, 100 00
    • CZ02; Clinitrial, s.r.o.
  • Praha, Czechia, 120 00
    • CZ16; Synexus Czech, s.r.o
  • Praha 5, Czechia, 150 00
    • CZ03; Praglandia s.r.o.
  • Prestice, Czechia, 33401
    • CZ08; Medison s.r.o.
  • Protivin, Czechia, 398 11
    • CZ04; Zdravi-fit, s.r.o.
  • Strakonice, Czechia, 386 01
    • CZ12; Ordinace pro TBC a Respiracni Nemoci - Strakonice
  • Vysoke Myto, Czechia, 56601
    • CZ01; Progerint s.r.o.
• Germany
  • Berlin, Germany, 10629
    • DE15; Emovis GmbH
  • Berlin, Germany, 10717
    • De10; Rcms
  • Berlin, Germany, 10787
    • DE21; Velocity Clinical Research Germany GmbH
  • Berlin, Germany, 12627
    • DE19; Synexus Clinical Research GmbH
  • Berlin-Mitte, Germany, 10117
    • DE17; Klinische Forschung Berlin-Mitte
  • Cottbus, Germany, 3050
    • DE30; MECS Cottbus GmbH
  • Delitzsch, Germany, 4509
    • DE28; Klifeck GmbH
  • Dresden, Germany, 1069
    • DE07; Klinische Forschung Dresden GmbH
  • Frankfurt, Germany, 60313
    • DE26; Synexus Clinical Research GmbH
  • Hamburg, Germany, 20253
    • DE06; Klinische Forschung Hamburg GmbH
  • Hannover, Germany, 30159
    • DE03; Klinische Forschung Hannover-Mitte GmbH
  • Leipzig, Germany, 4103
    • DE01; Leipzig Research Centre-Synexus Clinical Research GmbH
  • Leipzig, Germany, 4157
    • DE04; Facharzt fur Innere Medizin und Pneumologie
  • Leipzig, Germany, 4179
    • DE12; Studienzentrum FMZ
  • Munich, Germany, 80809
    • DE27; Centrum fuer Diagnostik und Gesundheit (CDG)
  • Naunhof, Germany, 4683
    • DE25; Gemeinschaftspraxis Dres. Holger Kittner und Kerstin Hartig
  • Peine, Germany, 31224
    • DE14; Studienzentrum Dr.med.Schlenska
• Japan
  • Fukuoka
    • Fukuoka-shi, Fukuoka, Japan, 814-0153
      • JP05; Tashiro Endocrinology Clinic
  • Hiroshima
    • Hiroshima-shi, Hiroshima, Japan, 730-0853
      • JP11; Haruta Respiratory Clinic
  • Hokkaido
    • Obihiro-shi, Hokkaido, Japan, 080-0013
      • JP12; Takahashi Internal Medicine and Respiratory Clinic
  • Hyogo-Ken
    • Himeji-Shi, Hyogo-Ken, Japan, 670-0942
      • JP14; Sawada Clinic
  • Kanagawa
    • Kawasaki-City, Kanagawa, Japan, 211-0041
      • JP09; Takahashi Internal Medicine
  • Niigata
    • Joetsu-shi, Niigata, Japan, 949-3443
      • JP08; Uchiyama Clinic
  • Oita
    • Oita-shi, Oita, Japan, 870-0921
      • JP10; Yamagata Clinic (Goto-J Respiratory and Allergy Clinic)
  • Tokyo
    • Chuo-Ku, Tokyo, Japan, 103-0027
      • JP03; Tokyo-Eki Center
    • Chuo-Ku, Tokyo, Japan, 104-0031
      • JP01; Fukuwa Clinic
    • Hachioji-shi, Tokyo, Japan, 192-0071
      • JP02; P-one Clinic
    • Shinjuku-ku, Tokyo, Japan, 169-0072
      • JP06; Higashi Shinjuku Clinic
  • Yamagata
    • Yonezawa-shi, Yamagata, Japan, 992-0045
      • JP04; Sanyudo Hospital
• Romania
  • Brasov, Romania, 500283
    • RO05; Centrul Medical de Diagnostic si Tratament Ambulatoriu Neomed SRL
  • Bucuresti, Romania, 11025
    • RO04; Sc Sana Monitoring Srl
  • Calarasi, Romania, 910103
    • RO06; Sc Ames Research Srl
• Slovakia
  • Hlohovec, Slovakia, 92001
    • SK04; DIVERSITAS s.r.o. - Hlohovec vseobecne
  • Kosice, Slovakia, 4001
    • SK08; IRS - Medicínska cinnost s.r.o.
  • Kosice, Slovakia, 4011
    • SK01; PANACEUM s.r.o.
  • Moldava Nad Bodvou, Slovakia, 045 01
    • SK02; MEDI M&M s.r.o.
  • Moldava nad Bodvou, Slovakia, 045 01
    • SK07; Hodosi-MED s.r.o.
  • Piestany, Slovakia, 92101
    • SK05; MEDIPA, s.r.o., Vseobecna ambulancia pre dospelych
  • Presov, Slovakia, 8001
    • SK12; PULMO s.r.o.
  • Pruske, Slovakia, 018 52
    • SK06; MUDr. Viliam Cibik, Phd, s.r.o.
  • Spišská Nová Ves, Slovakia, 052 01
    • SK10; Plucna ambulancia Hrebenar s.r.o.
  • Stiavnik, Slovakia, 1355
    • SK09; Aquilamed s. r. o.
  • Topolcany, Slovakia, 955 01
    • SK03; Alergia, s.r.o.
• United Kingdom
  • Buckinghamshire
    • High Wycombe, Buckinghamshire, United Kingdom, HP11 2QW
      • GB07; Egin Research Ltd
  • Kent
    • Orpington, Kent, United Kingdom, BR5 3QG
      • GB05; Accellacare South London
  • London
    • North Finchley, London, United Kingdom, N12 8BU
      • GB06; Velocity Clinical Research North London
  • Middlesex
    • Northwood, Middlesex, United Kingdom, HA6 2RN
      • GB04; Accellacare North London
  • Northamptonshire
    • Corby, Northamptonshire, United Kingdom, NN18 9EZ
      • GB03; Accellacare Northamptonshire
  • West Midlands
    • Coventry, West Midlands, United Kingdom, CV3 4FJ
      • GB02; Accellacare Warwickshire
  • Yorkshire
    • Shipley, Yorkshire, United Kingdom, BD18 3SA
      • GB01; Accellacare Yorkshire
• United States
  • Florida
    • Brandon, Florida, United States, 33511
      • US49; Clinical Research of Brandon LLC
    • Cape Coral, Florida, United States, 33909
      • US97; Riverside Research Group
    • Clearwater, Florida, United States, 33756
      • US38; Innovative Research Of West Florida, Inc.
    • Coral Gables, Florida, United States, 33134
      • US47; Hope Clinical Trials, Inc
    • Davie, Florida, United States, 33024
      • UX24; Alfa Medical Research
    • Doral, Florida, United States, 33122
      • US94; D & H Doral Research Center, LLC
    • Doral, Florida, United States, 33172
      • UX10; Unique Clinical Trials, LLC
    • Doral, Florida, United States, 33178
      • UX12; Solution Clinical Research
    • Fort Lauderdale, Florida, United States, 33308
      • US83; Proactive Clinical Research LLC
    • Fort Lauderdale, Florida, United States, 33309
      • UX01; 3Sync
    • Greenacres City, Florida, United States, 33467
      • US93; Finlay Medical Research
    • Hialeah, Florida, United States, 33016
      • US70; Harmony Medical Research Institute, Inc.
    • Homestead, Florida, United States, 33030
      • US68; Global Research Associates
    • Lakeland, Florida, United States, 33803
      • US01; Accel Research Sites-LKD CRU
    • Largo, Florida, United States, 33777
      • US25; Accel Research Sites
    • Leesburg, Florida, United States, 34748
      • US12; Leesburg Medical Research Institute, LLC
    • Maitland, Florida, United States, 32751
      • US20; Accel Clinical Research
    • Miami, Florida, United States, 33125
      • UX15; Med-Care Research Corp.
    • Miami, Florida, United States, 33126
      • US13; LCC Medical Research Institute, LLC
    • Miami, Florida, United States, 33126
      • US48; Ocean Clinical Research, LLC
    • Miami, Florida, United States, 33126
      • US80; Enmanuel Advance Research Center
    • Miami, Florida, United States, 33126
      • UX02; Finlay Medical Research
    • Miami, Florida, United States, 33135
      • US84; Global Health Clinical Trials
    • Miami, Florida, United States, 33135
      • US86; South Florida Research Center, Inc.
    • Miami, Florida, United States, 33155
      • US21; Bioclinical Research Alliance, Inc.
    • Miami, Florida, United States, 33155
      • US36; Allied Biomedical Research Institute
    • Miami, Florida, United States, 33155
      • US79; Cordova Research Institute, LLC
    • Miami, Florida, United States, 33155
      • US82; Florida International Medical Research
    • Miami, Florida, United States, 33155
      • UX25; D&H National Research Centers (Bird)
    • Miami, Florida, United States, 33156
      • US72; BioMed Research and Medical Center. LLC
    • Miami, Florida, United States, 33157
      • US55; American Research Institute
    • Miami, Florida, United States, 33165
      • US56; Medical Research of Westchester, Inc
    • Miami, Florida, United States, 33165
      • US95; Premier Research Associate, Inc
    • Miami, Florida, United States, 33165
      • UX06; Wellness Research Center Inc
    • Miami, Florida, United States, 33173
      • US37; Research Institute Of South Florida, Inc.
    • Miami, Florida, United States, 33176
      • US76; Reed Medical Research
    • Miami, Florida, United States, 33176
      • US91; Ambert Medical Research
    • Miami, Florida, United States, 33184
      • US90; Felicidad Medical Research
    • Miami, Florida, United States, 33186
      • US40; Clinical Trials of Florida, LLC
    • Miami, Florida, United States, 33186
      • UX07; Innovations Biotech
    • Miami, Florida, United States, 33186
      • UX11; United Research Group
    • Miami Lakes, Florida, United States, 33014
      • US43; San Marcus Research Clinic Inc
    • Miami Lakes, Florida, United States, 33014
      • US89; 3Sync Research - Hialeah
    • Miami Lakes, Florida, United States, 33016
      • US98; MedQuest Translational Sciences
    • North Miami Beach, Florida, United States, 33162
      • UX26; Harmony Clinical Research, Inc
    • Orlando, Florida, United States, 32806
      • UX17; AES Orlando
    • Orlando, Florida, United States, 32808
      • US04; Omega Research Consultants
    • Orlando, Florida, United States, 32825
      • US10; Florida Institute for Clinical Research
    • Palmetto Bay, Florida, United States, 33157
      • US57; Innovation Medical Group LLC
    • Pembroke Pines, Florida, United States, 33026
      • US58; Bioresearch Institute LLC
    • Sebring, Florida, United States, 33870
      • US41; Clinovation International Corp
    • Tamarac, Florida, United States, 33321
      • UX08; TBC Research Corp.
    • Tampa, Florida, United States, 33614
      • US50; Precision Research Center
    • Tampa, Florida, United States, 33614
      • UX04; Clinical Trials of Tampa
    • West Palm Beach, Florida, United States, 33409
      • US46; Palm Beach Research Center
    • Winter Park, Florida, United States, 32789
      • US45; Clinical Site Partners, Inc. d/b/a CSP Orlando
    • Winter Park, Florida, United States, 32789
      • US45; Clinical Site Partners, LLC - Winter Park, Florida Premier Research Institute (FPRI)
  • Georgia
    • Atlanta, Georgia, United States, 30328
      • UX99; Accelerated Enrollment Solutions (AES)
    • College Park, Georgia, United States, 30349
      • US81; Oracle Clinical Research
    • Columbus, Georgia, United States, 31904
      • UX22; ClinCept, LLC
    • Lilburn, Georgia, United States, 30047
      • US63; Lifeline Primary Care/CCT Research
    • Rincon, Georgia, United States, 31326
      • US31; IACTHealth d/b/a Centricity Research
  • Texas
    • Baytown, Texas, United States, 77521
      • US03; Inquest Clinical Research
    • Bellaire, Texas, United States, 77401
      • UX20; Novel Research, LLC
    • Cypress, Texas, United States, 77429
      • US42; Houston Pulmonary and Sleep Associates
    • Friendswood, Texas, United States, 77546
      • UX34; Mt.Olympus Medical Research
    • Houston, Texas, United States, 77022
      • US88; HDH Research Inc
    • Houston, Texas, United States, 77024
      • US73; Victorium Clinical Research
    • Houston, Texas, United States, 77036
      • US53; Alpha Research Institute, LLC
    • Houston, Texas, United States, 77043
      • US87; Biopharma Informatic Research Center
    • Houston, Texas, United States, 77054
      • UX14; Prolato Clinical Research Center
    • Houston, Texas, United States, 77099
      • UX09; Pioneer Research Solutions, Inc
    • Humble, Texas, United States, 77338
      • UX18; Accurate Clinical Research, Inc
    • McAllen, Texas, United States, 78503
      • US39; Proactive Clinical Research, LLC (formerly Invesclinic, U.S. LLC)
    • McKinney, Texas, United States, 75069
      • US62; Metroplex Pulmonary And Sleep Medicine Center
    • Mesquite, Texas, United States, 75149
      • UX16; Pioneer Research Solutions, Inc
    • Missouri City, Texas, United States, 77459
      • UX13; Synapse Clinical Research Inc.
    • San Antonio, Texas, United States, 78258
      • US59; Pulmonary and Sleep Institute
    • Sherman, Texas, United States, 75092
      • US52; Sherman Clinical Research
    • Stafford, Texas, United States, 77477
      • UX21; R & H Clinical Research
    • The Woodlands, Texas, United States, 77380
      • US74; Renovatio Clinical - The Woodlands Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: THS; Subjects who are not willing to quit smoking.	Other: THS use; Subjects who are not willing to quit smoking during the study duration will switch from cigarettes to using THS; Other Names: Tobacco Heating System 3.0
Active Comparator: Cigarette; Subjects who are not willing to quit smoking.	Other: Cigarette; Subjects who are not willing to quit smoking during the study duration will continue smoking their own preferred brand of commercially available cigarettes.
Active Comparator: Smoking Abstinence; Subjects who are willing to quit smoking.	Other: Smoking Abstinence; 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.)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disease Progression	Disease progression will be assessed by measuring Forced Expiratory Volume in 1 second (FEV1), post-bronchodilator	At month 36
COPD symptoms	COPD symptoms will be assessed from the total score of the COPD Assessment Test (CAT).	At month 12

Collaborators and Investigators

• Sponsor: Philip Morris Products S.A.
• Investigators: Study Chair: Christelle Haziza, PhD, Philip Morris Products S.A.

Study record dates

Study Major Dates

• Study Start (Actual): December 16, 2022
• Primary Completion (Actual): September 13, 2024
• Study Completion (Actual): September 13, 2024

Study Registration Dates

• First Submitted: September 30, 2022
• First Submitted That Met QC Criteria: October 3, 2022
• First Posted (Actual): October 6, 2022

Study Record Updates

• Last Update Posted (Actual): September 26, 2024
• Last Update Submitted That Met QC Criteria: September 24, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Disease Attributes; Bronchial Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Chronic Disease; Disease Progression; Bronchitis; Bronchitis, Chronic
• Other Study ID Numbers: P1-COPD-04-INT

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No