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

Conditions

• COPD
• Smoking
• Tobacco Use

Eligibility Criteria

Sex

ALL

Age

40 Years - N/A

Healthy Volunteers

Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date

Apr 2, 2025

Status verified

Jun 2026

Primary completion

Aug 31, 2026

Completion

Nov 30, 2026

Study Design

Enrollment

290 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Arms

• Active Comparator: Cigarette
• Active Comparator: THS

Primary Outcome Measure

Reduction in 24-hour cough frequency [ Time Frame: Measured from start of product use to end of week 24 (end of the exposure period). ]

Central Contacts

• Xavier Jaumont, MD
  +41582421111
  [email protected]

Locations (46)

Find similar trials in Clearwater, FL

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