NCT05569005|Terminated

Study Stopped

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

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.

Philip Morris Products S.A.ClinicalTrials.gov

Compare

1 other identifier

P1-COPD-04-INT

Study Type

interventional

Target

715

Locations

8 countries

Sites

170

Timeline

RegisteredOct 2022

StartedDec 2022

CompletionSep 2024

Brief 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 (THS) as compared to those who continue to smoke cigarettes.

Trial Health

Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

715

participants targeted

Target at P75+ for not_applicable

Timeline

Completed

Started Dec 2022

Geographic Reach

8 countries

170 active sites

Status

terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.7 years study duration

First Submitted

Initial submission to the registry

September 30, 2022

Completed

6 days until next milestone

First Posted

Study publicly available on registry

October 6, 2022

Completed

2 months until next milestone

Study Start

First participant enrolled

December 16, 2022

Completed

1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 13, 2024

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 13, 2024

Completed

Last Updated

September 26, 2024

Status Verified

September 1, 2024

Enrollment Period

1.7 years

First QC Date

September 30, 2022

Last Update Submit

September 24, 2024

Conditions

COPD Smoking Tobacco Use

Outcome Measures

Primary Outcomes (2)

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

Study Arms (3)

THS

ACTIVE COMPARATOR

Subjects who are not willing to quit smoking.

Other: THS use

Cigarette

ACTIVE COMPARATOR

Subjects who are not willing to quit smoking.

Other: Cigarette

Smoking Abstinence

ACTIVE COMPARATOR

Subjects who are willing to quit smoking.

Other: Smoking Abstinence

Interventions

THS useOTHER

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

Also known as: Tobacco Heating System 3.0

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.

Cigarette

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.)

Smoking Abstinence

Eligibility Criteria

Age35 Years - 65 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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.

You may not qualify if:

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)
+5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Philip Morris Products S.A.lead

Study Sites (170)

US49; Clinical Research of Brandon LLC

Brandon, Florida, 33511, United States

Location

US97; Riverside Research Group

Cape Coral, Florida, 33909, United States

Location

US38; Innovative Research Of West Florida, Inc.

Clearwater, Florida, 33756, United States

Location

US47; Hope Clinical Trials, Inc

Coral Gables, Florida, 33134, United States

Location

UX24; Alfa Medical Research

Davie, Florida, 33024, United States

Location

US94; D & H Doral Research Center, LLC

Doral, Florida, 33122, United States

Location

UX10; Unique Clinical Trials, LLC

Doral, Florida, 33172, United States

Location

UX12; Solution Clinical Research

Doral, Florida, 33178, United States

Location

US83; Proactive Clinical Research LLC

Fort Lauderdale, Florida, 33308, United States

Location

UX01; 3Sync

Fort Lauderdale, Florida, 33309, United States

Location

US93; Finlay Medical Research

Greenacres City, Florida, 33467, United States

Location

US70; Harmony Medical Research Institute, Inc.

Hialeah, Florida, 33016, United States

Location

US68; Global Research Associates

Homestead, Florida, 33030, United States

Location

US01; Accel Research Sites-LKD CRU

Lakeland, Florida, 33803, United States

Location

US25; Accel Research Sites

Largo, Florida, 33777, United States

Location

US12; Leesburg Medical Research Institute, LLC

Leesburg, Florida, 34748, United States

Location

US20; Accel Clinical Research

Maitland, Florida, 32751, United States

Location

UX15; Med-Care Research Corp.

Miami, Florida, 33125, United States

Location

US13; LCC Medical Research Institute, LLC

Miami, Florida, 33126, United States

Location

US48; Ocean Clinical Research, LLC

Miami, Florida, 33126, United States

Location

US80; Enmanuel Advance Research Center

Miami, Florida, 33126, United States

Location

UX02; Finlay Medical Research

Miami, Florida, 33126, United States

Location

US84; Global Health Clinical Trials

Miami, Florida, 33135, United States

Location

US86; South Florida Research Center, Inc.

Miami, Florida, 33135, United States

Location

US21; Bioclinical Research Alliance, Inc.