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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

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]

Male or female subjects aged ≥40 years

Must not have

Do you have any other respiratory conditions that might interfere with the study? (Asthma, antitrypsin deficiency, active tuberculosis, lung cancer, bronchiectasis, sarcoidosis, lung fibrosis, pulmonary hypertension, and interstitial lung disease)

Do you have any uncontrolled heart conditions? (Afib, heart disease, acute myocardial infraction) in the last 6 months?

Timeline

Screening 3 weeks

Treatment 52 weeks

Follow Up 1 weeks

Awards & highlights

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 smoked for 10 or more years but quit at least 6 months ago.

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I am 40 years old or older.

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I have been on a stable dose of daily inhaled medication for my COPD for at least 3 months.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

TRITON Trial Timeline

Screening ~ 3 weeks2 visits

Treatment ~ 52 weeks10 visits

Follow Up ~ 1 weeks1 visit

Screening ~ 3 weeks

Treatment ~ 52 weeks

Follow Up ~1 weeks

This trial's timeline: 3 weeks for screening, 52 weeks for treatment, and 1 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

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

0 / 7Eligibility criteria met

Find a Location

Logistics

Other reimbursement is provided

Other forms of reimbursement are provided for this trial.

Who is running the clinical trial?

Chiesi Farmaceutici S.p.A.Lead Sponsor

199 Previous Clinical Trials

309,004 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