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

NCT05569005 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 715

Last updated 2024-09-26

No results posted yet for this study

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.

Conditions

  • COPD
  • Smoking
  • Tobacco Use

Interventions

OTHER

THS use

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

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.

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.)

Sponsors & Collaborators

  • Philip Morris Products S.A.

    lead INDUSTRY

Principal Investigators

  • Christelle Haziza, PhD · Philip Morris Products S.A.

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
35 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-16
Primary Completion
2024-09-13
Completion
2024-09-13

Countries

  • United States
  • Bulgaria
  • Czechia
  • Germany
  • Japan
  • Romania
  • Slovakia
  • United Kingdom

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05569005 on ClinicalTrials.gov