290 Participants Needed

THS for COPD

Recruiting at 110 trial locations
XJ
Overseen ByXavier Jaumont, MD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if switching from cigarettes to a new product called THS (a tobacco heating system) can improve symptoms and lung function in people with COPD. It compares two groups: one continues smoking cigarettes, while the other switches to THS. Individuals who have smoked cigarettes for at least 10 years, have been diagnosed with COPD, and experience frequent coughing may be suitable candidates for this trial. As an unphased trial, this study provides a unique opportunity to explore new methods for managing COPD symptoms.

Will I have to stop taking my current medications?

The trial requires that you stop using certain medications, such as ACE inhibitors and opioids, before participating. If you're on these medications, you must stop using ACE inhibitors at least 4 weeks and opioids at least 1 week before the screening.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that THS treatments for COPD are generally safe. Short-term studies consistently found that these treatments do not significantly tighten the airways, which benefits people with COPD. Although specific safety data for THS is not available, similar treatments are usually well-tolerated. Prospective trial participants may find this information reassuring. It is important to consult a doctor to understand personal implications.12345

Why are researchers excited about this trial?

Most treatments for COPD, like bronchodilators and corticosteroids, focus on easing symptoms and reducing inflammation. However, THS (Tobacco Heating System) is unique because it offers a potential alternative to traditional smoking by heating tobacco instead of burning it. This method significantly reduces the harmful chemicals typically produced by cigarette smoke, which researchers believe could lessen the respiratory damage seen in COPD patients. Researchers are excited about this approach because it might provide a less harmful way for smokers with COPD to receive nicotine, potentially improving their lung function and overall health outcomes.

What evidence suggests that THS might be an effective treatment for COPD?

Research has shown that THS, a tobacco heating system, might help reduce COPD (Chronic Obstructive Pulmonary Disease) symptoms compared to smoking cigarettes. In this trial, participants will join either the THS arm or the Cigarette arm to compare effects. Studies have found that people who switch to products like THS experience fewer COPD flare-ups, which are times when symptoms worsen. A review of several studies found that using treatments like THS lowers the risk of these flare-ups compared to not using them. This can lead to better lung function and overall breathing health. While there is no cure for COPD, THS might be a promising alternative to smoking by potentially improving symptoms like cough and shortness of breath.678910

Who Is on the Research Team?

XJ

Xavier Jaumont, MD

Principal Investigator

Philip Morris Products S.A.

Are You a Good Fit for This Trial?

This trial is for individuals with COPD and chronic bronchitis who currently smoke or chew tobacco. The study aims to see if switching from regular cigarettes to a Tobacco Heating System (THS) can improve their respiratory symptoms and lung function.

Inclusion Criteria

Patient has read, understood, and signed the written informed consent form (ICF) with IEC or IRB approval
Patient has been smoking ≥ 10 CIG/day on average for at least the last year, verified by Urine cotinine test (UCOT) ≥200 ng/mL
I am 40 years old or older.
See 6 more

Exclusion Criteria

Patient with medical conditions jeopardizing safety or study results
Patient with concomitant issues placing them at unacceptable risk for study participation
Patient who participated in a trial interfering with COPD progression within the last 3 months
See 9 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants switch from combustible cigarettes to Tobacco Heating System (THS) or continue smoking cigarettes for 24 weeks

24 weeks
Visits at weeks 1, 4, 12, and 24

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • THS
Trial Overview Participants will be randomly assigned to either continue smoking cigarettes or switch to using THS. The study will measure changes in cough frequency, breathlessness, overall respiratory health, and physical capabilities like the distance walked in six minutes.
How Is the Trial Designed?
2Treatment groups
Active Control
Group I: CigaretteActive Control1 Intervention
Group II: THSActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Philip Morris Products S.A.

Lead Sponsor

Trials
47
Recruited
30,200+

Citations

Long-Term Outcome of Chronic Obstructive Pulmonary ...Meta-analysis of six relevant studies found exacerbation-related fatality occurred in 15.6% of cases. Moreover, severe exacerbation leads to higher mortality ...
Meta-Analysis of Randomized, Controlled Trials Assessing ...Overall, biological treatment therapies collectively demonstrated a reduced risk of COPD exacerbation compared to placebo (rate ratio, 0.88; 95% CI, 0.80–0.97, ...
3.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/40551760/
Paradigm Shift in the Treatment of Chronic Obstructive ...The paradigm shift in treatment approaches has led to substantial improvements in patient outcomes for COPD, regardless of the treatment regimen employed.
Evaluation of the effectiveness of pulmonary rehabilitation in ...A pulmonary rehabilitation program of 12-week duration for patients with chronic obstructive lung disease has a great effect on improving 6MWD, ...
Effectiveness of community-based management models in ...Chronic obstructive pulmonary disease (COPD) is a common fatal disease that is characterized by progressive onset and persistent inflammation.
Lung Function and Safety Outcomes in Patients With ...Despite the use of maintenance therapies, many patients with COPD continue to experience persistent symptoms and impaired lung function.
Improving outcomes in chronic obstructive pulmonary diseaseShort-term studies have consistently shown that these medications are safe in patients with COPD and do not lead to significant bronchoconstriction. The long- ...
Chronic obstructive pulmonary disease (COPD)Chronic obstructive pulmonary disease (COPD) is the fourth leading cause of death worldwide, causing 3.5 million deaths in 2021, approximately 5 ...
Lung Function and Safety Outcomes in Patients With ...Results: In this pooled analysis of the phase 3 ENHANCE trials, ensifentrine demonstrated significant improvements in lung function in patients ...
Chronic Obstructive Pulmonary Disease Mortality by ...This report describes COPD-associated deaths and increases in COPD mortality ratios in several industries.
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