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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
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I smoked for 10 or more years but quit at least 6 months ago.
Select...
I am 40 years old or older.
Select...
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:Timeline
Screening ~ 3 weeks2 visits
Treatment ~ 52 weeks10 visits
Follow Up ~ 1 weeks1 visit
Screening ~ 3 weeks
Treatment ~ 52 weeks
Follow Up ~1 weeks
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 moreTrial 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
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
200 Previous Clinical Trials
309,606 Total Patients Enrolled
Gregory M Feldman, MDPrincipal InvestigatorVitalink Research - Spartanburg
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a pre- and post-bronchodilator FEV1/FVC ratio <0.I've been to the hospital or doctor for my COPD getting worse in the last year.I have been diagnosed with COPD for over a year.I have recent lung scans without major issues, except for COPD.I am not currently hospitalized.I cannot become pregnant or will use effective birth control during the study.I smoked for 10 or more years but quit at least 6 months ago.I have been on a stable dose of daily inhaled medication for my COPD for at least 3 months.I smoked for 10 or more years but quit at least 6 months ago.You have a high score on a breathing test called the COPD Assessment Test (CAT).I am 40 years old or older.I have been diagnosed with COPD for over a year.I am 50 years old or older.I have COPD with specific lung function and history of exacerbations.I have not been diagnosed with cancer.I am not currently hospitalized.You have a score of 10 or more on the COPD Assessment Test (CAT).My lung function is reduced, and I've had at least one severe lung flare-up in the last year.I have been on a stable dose of daily inhaled medication for my COPD for at least 3 months.I am 40 years old or older.You must have signed and dated a written informed consent prior to initiating any study-related procedures.
Research Study Groups:
This trial has the following groups:- Group 1: BDP/FF/GB - CHF 5993
- Group 2: BDP/FF - CHF 1535
Awards:
This trial has 2 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: You will receive the treatment for 52 Weeks
- Follow Ups: You may be asked to continue sharing information regarding the trial for 1 Weeks after you stop receiving the treatment.
COPD Patient Testimony for trial: Trial Name: NCT04320342 — Phase 3
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