BridgeMD
Compares treatment options for COPD
Official title Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
ClinicalTrials.gov ID: NCT07108166
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 and older
You may be able to join if
- Adult, both sexes, aged ≥ 40 years.
- Patient has read, understood, and signed the written informed consent form (ICF), which has received IEC or IRB approval.
- Patient with body mass index (BMI) 17.6-40.0 kg/m2 and body weight \> 50 kg (male) or \> 40 kg (female). Checked at V1 and V2.
- Patient has a CIG smoking history ≥ 10 years.
- Patient has been smoking ≥ 10 commercially available and/or roll-your-own CIG/day on average (no brand restriction) for at least the last year (based...
You likely can't join if
- Patient who self-report concomitant daily use of inhaled cannabis or any type of nicotine containing products other than CIG within the last year.
- Patient with COPD (moderate or severe) exacerbation that has not resolved according to the GOLD standard (e.g., requirement of additional therapy) or...
- Patient with currently active cancer or history of any cancer within the last 5 years prior to V1, except for those with basal cell carcinoma of the...
- Patient with acute worsening symptoms of chronic bronchitis or other active respiratory or systemic infections that have not resolved. Checked at V1...
- Patient with medical condition(s) that would jeopardize his(her) safety in the context of this study (e.g., safety laboratory parameters, abnormal...
- Patient is legally incompetent, physically, and/or mentally incapable of giving consent (e.g., emergency situation, under guardianship, in a social...
See the full eligibility criteria
Who can join
- Adult, both sexes, aged ≥ 40 years.
- Patient has read, understood, and signed the written informed consent form (ICF), which has received IEC or IRB approval.
- Patient with body mass index (BMI) 17.6-40.0 kg/m2 and body weight \> 50 kg (male) or \> 40 kg (female). Checked at V1 and V2.
- Patient has a CIG smoking history ≥ 10 years.
- Patient has been smoking ≥ 10 commercially available and/or roll-your-own CIG/day on average (no brand restriction) for at least the last year (based on self-reporting). Smoking status will be verified by Urine cotinine...
- Patient has been advised to quit smoking, informed of smoking risks and of cessation programs as per SoC at V2, and is not willing to quit CIG use for the study duration. Checked at V1 and V2.
- Patient agrees to be assigned by chance into one of the two study arms. Checked at V2.
- Patient with confirmed COPD via spirometry performed at V1 (FEV1/FVC \ three months a year for the two consecutive years prior to the screening visit). Checked at V2.
- Patient has cough frequency of ≥ 10 cough/hour during daytime from objective count sensor applied at V1, used to verify eligibility at V2. (Daytime is defined as occurring between 07:00:00 and 22:59:59, based on the...
What rules you out
- Patient who self-report concomitant daily use of inhaled cannabis or any type of nicotine containing products other than CIG within the last year.
- Patient with COPD (moderate or severe) exacerbation that has not resolved according to the GOLD standard (e.g., requirement of additional therapy) or investigator's discretion. Checked at V1 and V2.
- Patient with currently active cancer or history of any cancer within the last 5 years prior to V1, except for those with basal cell carcinoma of the skin.
- Patient with acute worsening symptoms of chronic bronchitis or other active respiratory or systemic infections that have not resolved. Checked at V1 and V2.
- Patient with medical condition(s) that would jeopardize his(her) safety in the context of this study (e.g., safety laboratory parameters, abnormal ECG) or with a condition that would jeopardize study results (e.g...
- Patient is legally incompetent, physically, and/or mentally incapable of giving consent (e.g., emergency situation, under guardianship, in a social or sanitary establishment, prisoner or involuntarily incarcerated...
- Patient with a history of asthma.
- Employee of the investigational site or any other party involved in the study, or their first-degree relatives (parent, child, spouse).
- Current or former employee of the tobacco or e-cigarette industry or their 1st-degree relatives.
- Patient with active or history of alcohol and/or drug abuse within the past year.
- Patient with positive serological tests for human immunodeficiency virus (HIV) 1/2, hepatitis B or C (Hep B/C).
- Patient with any concomitant issues (e.g., medical, psychiatric, and/or social reason) that, as per Investigator's discretion, would place the study patient at an unacceptable risk for participation in the study.
- Patient who participated in any trial (for investigational medicine, or other type of intervention) that may have interfered with COPD disease progression and symptoms (including cough and dyspnea) within the last three...
- Patient using any systemic (injectable or oral) corticosteroids (acute or chronic treatments) or oxygen therapy in the last 2 months excluding short term use for a COPD exacerbation.
- Patient currently being treated with angiotensin-converting enzyme (ACE) inhibitors or opioids, or those who have used ACE inhibitors within 4 weeks or opioids within 1 week prior to screening. Checked at V1 and V2.
- Patient treated with biologic therapies for COPD (e.g., Dupilumab) in the last 6 months.
- Female patient is pregnant, breastfeeding or lactating, or anticipating becoming pregnant withing the duration of the study. Checked at V1 and V2.
- Female of childbearing potential who is capable of getting pregnant, defined as a female patient who does not agree to use an acceptable method of effective contraception during the entire study, a female patient that...
The study team makes the final eligibility decision.
Where it's taking place
- Clearwater, Florida, United States
- Coral Gables, Florida, United States
- Davie, Florida, United States
- DeBary, Florida, United States
- Doral, Florida, United States
- Hialeah, Florida, United States
- Hollywood, Florida, United States
- Margate, Florida, United States
- Miami, Florida, United States
- Miami Lakes, Florida, United States
- New Port Richey, Florida, United States
- North Miami Beach, Florida, United States
- Orlando, Florida, United States
- Plantation, Florida, United States
- Port Saint Lucie, Florida, United States
- St. Petersburg, Florida, United States
- Tamarac, Florida, United States
- Tampa, Florida, United States
- Stonecrest, Georgia, United States
- Denison, Texas, United States
+ 62 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 40 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Clearwater, Florida, United States; Coral Gables, Florida, United States; Davie, Florida, United States; DeBary, Florida, United States; Doral, Florida, United States; Hialeah, Florida, United States and 76 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.