NCT05569005

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.

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 715 (actual)
• Sponsor: Philip Morris Products S.A. · Industry
• Sex: All
• Age: 35 Years – 65 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• COPD
• Smoking
• Tobacco Use

Interventions

Type	Name	Description
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.)

Timeline

• Start date: 2022-12-16
• Primary completion: 2024-09-13
• Completion: 2024-09-13
• First posted: 2022-10-06
• Last updated: 2024-09-26

Locations

170 sites across 8 countries: United States, Bulgaria, Czechia, Germany, Japan, Romania, Slovakia, United Kingdom