NCT07108166

Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS

A Randomized, Single (Operator)-Blinded, Controlled Clinical Study for Assessing Major Symptoms and Function in Patients With Chronic Obstructive Pulmonary Disease (COPD) With Chronic Bronchitis Who Switch From Combustible Cigarettes (CIG) to Tobacco Heating System (THS)

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 290 (estimated)
• Sponsor: Philip Morris Products S.A. · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this randomized study is to demonstrate direct clinical benefit, i.e., observed benefits in how humans with COPD feel in terms of symptoms (e.g., cough frequency, shortness of breath, and other respiratory symptoms) and function (e.g., lung function, and six-minute walking test \[6MWT\]) after switching to THS compared to continuing to smoking cigarettes.

Conditions

• COPD
• Smoking
• Tobacco Use

Interventions

Type	Name	Description
OTHER	Cigarette	COPD patients will continue to smoke their cigarettes ad libitum, with no brand restrictions.
OTHER	THS	COPD patients will switch from cigarette smoking to ad libitum THS use, with no flavor variant restrictions.

Timeline

• Start date: 2025-04-02
• Primary completion: 2026-08-01
• Completion: 2026-11-01
• First posted: 2025-08-06
• Last updated: 2025-09-12

Locations

111 sites across 9 countries: United States, Bulgaria, Czechia, Germany, Japan, Poland, Romania, Slovakia, United Kingdom