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Corticosteroid

Fixed Dose Triple vs Dual Combination for COPD (TRITON Trial)

Verified Trial
Phase 3
Recruiting
Led By Gregory M Feldman, MD
Research Sponsored by Chiesi Farmaceutici S.p.A.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Male or female subjects aged ≥40 years
Current or ex-smokers who quit smoking at least 6 months prior to screening with a smoking history of at least 10 pack-years [pack-years = (number of cigarettes per day x number of years)/20]
Timeline
Screening 15 days
Treatment 52 weeks
Follow Up 2 weeks
Awards & highlights
Pivotal Trial
No Placebo-Only Group

TRITON Trial Summary

This trial is testing whether CHF 5993 is more effective than CHF 1535 at improving lung function, reducing exacerbations of COPD, and improving other clinical outcomes.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Potential side effects may include respiratory symptoms like coughing or wheezing, headaches, throat irritation, muscle cramps, dry mouth from Glycopyrronium Bromide; Formoterol Fumarate might cause palpitations or tremors; Beclomethasone Dipropionate could lead to hoarseness or oral infections.

TRITON Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 40 years old or older.
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I smoked for 10 or more years but quit at least 6 months ago.
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My lung function is reduced, and I've had at least one severe lung flare-up in the last year.
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I have been on a stable dose of daily inhaled medication for my COPD for at least 3 months.
Select...
I am 40 years old or older.
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I have been diagnosed with COPD for over a year.
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I smoked for 10 or more years but quit at least 6 months ago.
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I have been on a stable dose of daily inhaled medication for my COPD for at least 3 months.
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I have recent lung scans without major issues, except for COPD.

TRITON Trial Timeline

Screening ~ 15 days
Treatment ~ 52 weeks
Follow Up ~2 weeks
This trial's timeline: 15 days for screening, 52 weeks for treatment, and 2 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change from baseline in pre-dose morning Forced Expiratory Volume in the 1st second (FEV1) at Week 28
Secondary outcome measures
CAT response (decrease from baseline ≥2 points) at designated clinic visits
Change from baseline in 2-hour post-dose morning FEV1 at Week 28
Change from baseline in 2-hour post-dose morning FEV1 designated clinic visits
+18 more

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

TRITON Trial Design

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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Formoterol Fumarate
2011
Completed Phase 4
~8160
Glycopyrronium Bromide
2014
Completed Phase 4
~40

Find a Location

Who is running the clinical trial?

Chiesi Farmaceutici S.p.A.Lead Sponsor
197 Previous Clinical Trials
309,058 Total Patients Enrolled
Gregory M Feldman, MDPrincipal InvestigatorVitalink Research - Spartanburg

Media Library

Beclomethasone Dipropionate (Corticosteroid) Clinical Trial Eligibility Overview. Trial Name: NCT04320342 — Phase 3
COPD Research Study Groups: BDP/FF/GB - CHF 5993, BDP/FF - CHF 1535
COPD Clinical Trial 2023: Beclomethasone Dipropionate Highlights & Side Effects. Trial Name: NCT04320342 — Phase 3
Beclomethasone Dipropionate (Corticosteroid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04320342 — Phase 3
COPD Patient Testimony for trial: Trial Name: NCT04320342 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any other notable clinical trials that have utilized Beclomethasone Dipropionate?

"463 clinical trials have been completed for Beclomethasone Dipropionate since it was first studied in 2007 at the Arthur F Gelb Medical Corporation. As of right now, there are 28 active studies being conducted; a majority of these are located in Easley, South carolina."

Answered by AI

What medical conditions has Beclomethasone Dipropionate been known to improve?

"Beclomethasone Dipropionate is most often used to help with bodily secretions. In some cases, it can also be prescribed when a patient needs a quick anticholinergic effect, has sinusitis, or vasomotor rhinitis."

Answered by AI

Are there any current openings for people who want to participate in this research project?

"That is correct, the study detailed on clinicaltrials.gov is looking for more participants as of May 23rd, 2022. This specific trial was first posted on April 28th of this year and 100 different locations are signed up to help with recruitment. In total, they need 2934 individuals to sign up for the study."

Answered by AI

In how many different locations is this trial taking place?

"Currently, there are 100 medical centres conducting this trial. Some notable locations include Chiesi Clinical Trial Site 840204 in Easley, Chiesi Clinical Trial Site 840195 in Jupiter, and Chiesi Clinical Trial Site 840111 in Greenville."

Answered by AI

Could you please explain the risks associated with Beclomethasone Dipropionate?

"There is some evidence, from both Phase 3 data and multiple rounds of safety testing, that supports the use of Beclomethasone Dipropionate."

Answered by AI

How many individuals are part of this clinical trial in total?

"In order to move forward with this research, 2,934 individuals that fit the pre-determined criteria must enroll. These patients can choose to participate at any of the numerous locations, such as Chiesi Clinical Trial Site 840204 in Easley, South carolina and Chiesi Clinical Trial Site 840195 in Jupiter, Tennessee."

Answered by AI

Who else is applying?

What state do they live in?
Michigan
Other
Florida
Texas
How old are they?
65+
18 - 65
What site did they apply to?
Chiesi Clinical Trial Site 840223
Chiesi Clinical Trial Site 840190
Chiesi Clinical Trial Site 840128
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
2
1
0
3+

Why did patients apply to this trial?

Want to be able to breathe better. My COPD is impacting my daily activities.
PatientReceived 2+ prior treatments
I've been trying remote treatment for COPD and I would like to find other options.
PatientReceived 2+ prior treatments
To see if there is anything at all you can do to help my breathing as it's getting worse.
PatientReceived no prior treatments
The medication I have been using doesnt seem to do much anymore. I would like to see if there is something better.
PatientReceived 1 prior treatment

What questions have other patients asked about this trial?

How long is the clinical trial?
PatientReceived 2+ prior treatments

How responsive is this trial?

Average response time
  • < 1 Day
Most responsive sites:
  1. Chiesi Clinical Trial Site 840274: < 24 hours
Typically responds via
Phone Call
Recent research and studies
~451 spots leftby Jul 2024