Ignite Creation Date:
2025-12-24 @ 4:36 PM
Ignite Modification Date:
2025-12-29 @ 11:24 PM
Study NCT ID:
NCT07108166
Status:
RECRUITING
Last Update Posted:
2025-09-12
First Post:
2025-05-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
Sponsor:
Philip Morris Products S.A.
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: