Fixed Dose Triple vs Dual Combination for COPD
(TRITON Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores the effectiveness of a triple combination inhaler treatment compared to a dual combination inhaler for people with COPD, a lung disease that makes breathing difficult. The trial focuses on improving lung function and reducing symptom flare-ups. Participants will use an inhaler with either three medications—Beclomethasone Dipropionate, Formoterol Fumarate, and Glycopyrronium Bromide—or two medications for about a year. This trial suits those diagnosed with COPD for over a year, who experience frequent symptom flare-ups, and currently use a daily inhaler. As a Phase 3 trial, it represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking treatment for COPD.
Do I need to stop my current medications for this trial?
The trial requires that you stop using certain medications before and during the trial. Specifically, you must not use systemic/oral/parenteral corticosteroids, antibiotics for lower respiratory tract infections or COPD exacerbations, long-term chronic maintenance antibiotics, or oral xanthine derivatives like theophylline within specified periods before the screening visit. Additionally, you cannot be on non-cardioselective β-blockers or require long-term oxygen therapy. If you are on any of these medications, you may need to stop them to participate in the trial.
Will I have to stop taking my current medications?
The trial requires that you stop taking certain medications before joining, such as oral corticosteroids, antibiotics for respiratory infections, and oral xanthine derivatives. If you're on these, you'll need to stop them for a specific period before the screening.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that the treatment combinations being tested, CHF 5993 and CHF 1535, have promising safety records from previous studies.
CHF 5993 combines three ingredients: beclomethasone dipropionate, formoterol fumarate, and glycopyrronium bromide. Studies indicate that this combination is generally well-tolerated, improving lung function and reducing COPD flare-ups without major safety concerns. However, some studies report mild to moderate side effects, which are common with similar treatments.
CHF 1535 contains two ingredients: beclomethasone dipropionate and formoterol fumarate. Evidence suggests it is safe for most people and has been used in other COPD treatments with a good safety record. Some users might experience mild side effects, but these are usually manageable.
Overall, both treatments have been tested and are considered safe based on previous research. Participants can expect the usual side effects associated with inhaled COPD medications, but serious issues are rare.12345Why do researchers think this study treatment might be promising for COPD?
Unlike the standard treatments for COPD, which often involve dual combination inhalers, the study treatment combines three active ingredients: Beclomethasone Dipropionate, Formoterol Fumarate, and Glycopyrronium Bromide. This fixed-dose triple combination offers the benefits of an inhaled corticosteroid, a long-acting beta-agonist, and a long-acting muscarinic antagonist all in one, potentially enhancing lung function and symptom control. Researchers are excited because this could mean fewer inhalers for patients to manage and possibly better overall outcomes by targeting multiple pathways of the disease simultaneously.
What evidence suggests that this trial's treatments could be effective for COPD?
This trial will compare two treatment arms for COPD. The triple combination treatment, CHF 5993, includes beclomethasone dipropionate, formoterol fumarate, and glycopyrronium bromide. Studies have shown that this combination improves lung function and reduces flare-ups in people with COPD, outperforming treatments with only two medications.
The dual treatment, CHF 1535, contains beclomethasone dipropionate and formoterol fumarate. Research indicates that it reduces COPD flare-ups and improves lung function, offering more benefits than using formoterol alone. Both treatments in this trial aim to help patients breathe more easily and reduce the frequency of COPD flare-ups.46789Who Is on the Research Team?
Gregory Feldman, MD
Principal Investigator
Vitalink Research - Spartanburg
Are You a Good Fit for This Trial?
This trial is for COPD patients aged 40 or above with a history of smoking and recent exacerbations. They must have used stable inhaled maintenance therapy for at least 3 months, demonstrate correct inhaler use, and agree to birth control if applicable. Cancer patients, those under age 50 without COPD diagnosis, or hospital visits for COPD within the last year are excluded.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Run-in
Participants continue their regular COPD maintenance therapies before randomization
Treatment
Participants receive either CHF 5993 or CHF 1535 for 52 weeks with assessments at 4 weeks and every 6 weeks thereafter
Follow-up
A follow-up safety phone call is performed a week after the last clinic visit
What Are the Treatments Tested in This Trial?
Interventions
- Beclomethasone Dipropionate
- Formoterol Fumarate
- Glycopyrronium Bromide
Beclomethasone Dipropionate is already approved in European Union, United States, Canada, Japan for the following indications:
- Asthma
- Chronic Obstructive Pulmonary Disease (COPD)
- Allergic Rhinitis
- Dermatoses
- Asthma
- Chronic Obstructive Pulmonary Disease (COPD)
- Allergic Rhinitis
- Asthma
- Chronic Obstructive Pulmonary Disease (COPD)
- Allergic Rhinitis
- Asthma
- Chronic Obstructive Pulmonary Disease (COPD)
- Allergic Rhinitis
Find a Clinic Near You
Who Is Running the Clinical Trial?
Chiesi Farmaceutici S.p.A.
Lead Sponsor