Fixed Dose Triple vs Dual Combination for COPD
(TRITON Trial)
Trial Summary
What is the purpose of this trial?
The purpose of this study is to compare CHF 5993 with CHF 1535 in improving lung function, reducing moderate and severe COPD exacerbations, and other clinical efficacy and safety outcomes in the target subject population.
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.
What data supports the idea that Fixed Dose Triple vs Dual Combination for COPD is an effective drug?
The available research shows that using a Fixed Dose Triple drug, which combines three medications in one inhaler, is more effective for treating COPD than using a Dual Combination drug, which combines only two medications. Studies like the TRILOGY and TRINITY trials found that patients using the triple combination had better outcomes compared to those using the dual combination. This means that people with COPD experienced better breathing and overall health when using the triple combination drug. Additionally, the TRITRIAL study in Italy and the TRICOP study in Austria confirmed these benefits in real-world settings, showing that the triple combination drug is effective and well-tolerated by patients.12345
What data supports the effectiveness of the drug for COPD?
Research shows that the combination of beclometasone dipropionate, formoterol fumarate, and glycopyrronium bromide (BDP/FF/GB) in a single inhaler is effective for treating COPD. Studies like TRILOGY and TRINITY have demonstrated its efficacy compared to other treatments, and real-world studies like TRITRIAL and TRICOP have confirmed its effectiveness and tolerability in everyday settings.12345
What safety data is available for fixed dose triple vs dual combination therapy for COPD?
The safety of fixed dose triple therapy with beclometasone dipropionate, formoterol fumarate, and glycopyrronium bromide (BDP/FF/GB) has been evaluated in several studies. The TRILOGY and TRINITY trials assessed the efficacy and safety of this combination in COPD patients, showing it to be effective. The TRITRIAL study aims to evaluate its impact in a real-world setting. Additionally, the combination of indacaterol and glycopyrronium bromide (QVA149) has been studied in 14 randomized controlled trials, demonstrating a good safety profile and superior or non-inferior bronchodilator effects compared to other treatments. Overall, these studies suggest that fixed dose triple therapy is safe and effective for COPD treatment.12467
Is the fixed-dose triple therapy for COPD safe for humans?
The fixed-dose triple therapy with beclometasone dipropionate, formoterol fumarate, and glycopyrronium bromide has been evaluated in several studies and generally shows a good safety profile. It has been compared to other treatments and found to have similar or fewer side effects, making it a safe option for treating COPD.12467
Is the drug Beclomethasone Dipropionate, Formoterol Fumarate, Glycopyrronium Bromide a promising treatment for COPD?
What makes the drug Beclomethasone/Formoterol/Glycopyrronium unique for COPD treatment?
This drug is unique because it combines three medications into a single inhaler, making it easier for patients to use. It includes an inhaled corticosteroid, a long-acting beta2 agonist, and a long-acting muscarinic antagonist, which together help reduce COPD symptoms and prevent flare-ups more effectively than dual combinations.12458
Research Team
Gregory Feldman, MD
Principal Investigator
Vitalink Research - Spartanburg
Eligibility Criteria
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
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
Treatment Details
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