3433 Participants Needed

Fixed Dose Triple vs Dual Combination for COPD

(TRITON Trial)

Recruiting at 518 trial locations
CC
Overseen ByChiesi Clinical Trial Info
Age: 18+
Sex: Male
Trial Phase: Phase 3
Sponsor: Chiesi Farmaceutici S.p.A.
Must be taking: Inhaled maintenance therapy
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human 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?

Yes, the drug is promising for treating COPD. It combines three medications into one inhaler, which can help improve how well patients stick to their treatment plan and manage their symptoms better. Studies show it can reduce the risk of COPD flare-ups and improve overall health status.12458

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

GM

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

You have a pre- and post-bronchodilator FEV1/FVC ratio <0.
I have been diagnosed with COPD for over a year.
Documentation (including imagery and report) of chest x-ray (CXR) or CT scan performed within 6 months prior to the screening visit, without evidence of significant abnormalities (other than those related to the presence of COPD).
See 18 more

Exclusion Criteria

I've been to the hospital or doctor for my COPD getting worse in the last year.
Do you have any uncontrolled heart conditions? (Afib, heart disease, acute myocardial infraction) in the last 6 months?
Do you use a nebulizer to take your medication?
See 3 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (in-person)

Run-in

Participants continue their regular COPD maintenance therapies before randomization

2 weeks
1 visit (in-person)

Treatment

Participants receive either CHF 5993 or CHF 1535 for 52 weeks with assessments at 4 weeks and every 6 weeks thereafter

52 weeks
9 visits (in-person)

Follow-up

A follow-up safety phone call is performed a week after the last clinic visit

1 week
1 call (virtual)

Treatment Details

Interventions

  • Beclomethasone Dipropionate
  • Formoterol Fumarate
  • Glycopyrronium Bromide
Trial Overview The study compares two treatments: CHF 5993 (a triple combination) versus CHF 1535 (a dual combination), both containing drugs that help improve lung function. It aims to see which one better reduces lung issues and is safer over time.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: BDP/FF/GB - CHF 5993Experimental Treatment3 Interventions
Two inhalations twice daily of BDP/FF/GB (100/6/12.5μg) for a period of 52 weeks via pressurized metered dose inhaler
Group II: BDP/FF - CHF 1535Active Control2 Interventions
Two inhalations twice daily of BDP/FF (100/6μg) for a period of 52 weeks via pressurized metered dose inhaler

Beclomethasone Dipropionate is already approved in European Union, United States, Canada, Japan for the following indications:

🇪🇺
Approved in European Union as Beclomethasone Dipropionate for:
  • Asthma
  • Chronic Obstructive Pulmonary Disease (COPD)
  • Allergic Rhinitis
  • Dermatoses
🇺🇸
Approved in United States as Beclomethasone Dipropionate for:
  • Asthma
  • Chronic Obstructive Pulmonary Disease (COPD)
  • Allergic Rhinitis
🇨🇦
Approved in Canada as Beclomethasone Dipropionate for:
  • Asthma
  • Chronic Obstructive Pulmonary Disease (COPD)
  • Allergic Rhinitis
🇯🇵
Approved in Japan as Beclomethasone Dipropionate for:
  • 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

Trials
206
Recruited
315,000+
Founded
1935
Headquarters
Parma, Italy
Known For
Respiratory diseases
Top Products
NEXThaler, Trimbow, Curosurf, Holoclar

Findings from Research

The TRITRIAL study is a 12-month observational study involving 800 COPD patients in Italy, aimed at assessing the real-world effectiveness of the fixed triple combination therapy BDP/FF/G, focusing on changes in health status as measured by the CAT score.
This study will also evaluate important factors such as patient adherence, quality of life, and device usability, which are critical for the successful management of COPD in everyday clinical practice.
The Impact of Fixed Triple Therapy with Beclometasone/Formoterol/Glycopyrronium on Health Status and Adherence in Chronic Obstructive Pulmonary Disease (COPD) in an Italian Context of Real Life: The TRITRIAL Study Protocol.Richeldi, L., Piraino, A., Macagno, F., et al.[2022]
In a study involving 2691 patients with severe COPD, the fixed triple therapy (beclometasone dipropionate, formoterol fumarate, and glycopyrronium bromide) significantly reduced the rate of moderate-to-severe exacerbations compared to tiotropium alone, demonstrating its superior efficacy.
The fixed triple therapy also showed a significant improvement in lung function (measured by FEV1) compared to tiotropium, while being non-inferior to the open triple therapy, indicating its effectiveness in managing COPD symptoms.
Single inhaler extrafine triple therapy versus long-acting muscarinic antagonist therapy for chronic obstructive pulmonary disease (TRINITY): a double-blind, parallel group, randomised controlled trial.Vestbo, J., Papi, A., Corradi, M., et al.[2022]
In a real-world study of 265 COPD patients over 52 weeks, the single-inhaler triple therapy (beclometasone-dipropionate, formoterol-fumarate, and glycopyrronium) significantly improved lung function and reduced symptoms, with a notable 57.4% reduction in moderate and severe exacerbations.
The treatment was well-tolerated, with 93.7% of patients continuing after a year, and while there were 21 reported adverse events, none were deemed drug-related, indicating a favorable safety profile.
TRICOP - A Real-world effectiveness study with a single-inhaler extrafine triple therapy over 52 weeks in Austrian patients with COPD.Marth, K., Renner, A., Pohl, W.[2021]

References

The Impact of Fixed Triple Therapy with Beclometasone/Formoterol/Glycopyrronium on Health Status and Adherence in Chronic Obstructive Pulmonary Disease (COPD) in an Italian Context of Real Life: The TRITRIAL Study Protocol. [2022]
Single inhaler extrafine triple therapy versus long-acting muscarinic antagonist therapy for chronic obstructive pulmonary disease (TRINITY): a double-blind, parallel group, randomised controlled trial. [2022]
TRICOP - A Real-world effectiveness study with a single-inhaler extrafine triple therapy over 52 weeks in Austrian patients with COPD. [2021]
Single inhaler triple therapy versus inhaled corticosteroid plus long-acting β2-agonist therapy for chronic obstructive pulmonary disease (TRILOGY): a double-blind, parallel group, randomised controlled trial. [2022]
Efficacy and safety of single-inhaler extrafine triple therapy versus inhaled corticosteroid plus long-acting beta2 agonist in eastern Asian patients with COPD: the TRIVERSYTI randomised controlled trial. [2021]
Fixed-dose combination of indacaterol/glycopyrronium/mometasone furoate once-daily versus salmeterol/fluticasone twice-daily plus tiotropium once-daily in patients with uncontrolled asthma: A randomised, Phase IIIb, non-inferiority study (ARGON). [2021]
Role of combined indacaterol and glycopyrronium bromide (QVA149) for the treatment of COPD in Japan. [2020]
Efficacy and safety of triple combination therapy for treating chronic obstructive pulmonary disease: an expert review. [2021]
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