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Corticosteroid

BGF arm for Chronic Obstructive Pulmonary Disease (THARROS Trial)

Q: Which specific individuals are considered the ideal candidates for inclusion in this clinical trial?

Individuals aged between 40 and 80 diagnosed with chronic obstructive pulmonary disease are eligible for participation in this trial, which aims to enroll a total of 5000 candidates.

Q: Are there any available positions for patients to participate in this clinical trial?

As per the details provided on clinicaltrials.gov, this particular research endeavor is presently not in pursuit of additional participants. Although it was first listed on 2/22/2024 and updated most recently on 2/21/2024, there are currently 498 alternative clinical trials actively seeking eligible candidates for enrollment.

Q: At how many different sites is this study currently being conducted?

At present, this research project is operating from 489 diverse sites. Some of these include Florencio Varela, Santo Andre, and Yambol among many others. Opting for the nearest clinic can reduce travel burdens when participating in this study.

Q: Has the BGF treatment regimen received official approval from the FDA?

Based on our team's evaluation at Power, the safety rating for the BGF treatment arm in this Phase 3 trial is graded as a level 3. This grading signifies existing efficacy data along with comprehensive safety information collected over multiple assessment periods.

Q: Does this research project include individuals aged 85 and above in its patient recruitment process?

To be considered for participation in this research project, individuals aged between 40 and 80 are eligible. It is noteworthy that there are a total of 38 investigations targeting those below the age of majority as well as 481 trials focusing on elderly individuals above 65 years old.

Phase 3

Recruiting

Research Sponsored by AstraZeneca

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

A diagnosis of COPD confirmed by a post-bronchodilator FEV1/FVC ratio < 70% at V1

Current or former smokers with a history of at least 10 pack-years of cigarette smoking

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years

Awards & highlights

THARROS Trial Summary

This trial will compare the effect of using a combination inhaler (BGF) containing three types of medication versus a different combination inhaler (GFF) in people with COPD and high risk for

Who is the study for?

This trial is for people with Chronic Obstructive Pulmonary Disease (COPD) who are at high risk of heart and lung complications. Participants should not have other health conditions that could interfere with the study or be using certain medications.Check my eligibility

What is being tested?

The study tests a combination inhaler therapy (BGF MDI) against a dual therapy inhaler (GFF MDI). It aims to see if adding an extra drug to the usual treatment can improve heart and lung function in COPD patients.See study design

What are the potential side effects?

Possible side effects may include throat irritation, hoarseness, dry mouth, coughing, headaches, respiratory infections like pneumonia, and potentially worsened breathing problems.

THARROS Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have been diagnosed with COPD, confirmed by a specific lung function test.

Select...

I have smoked at least 10 pack-years.

Select...

I am between 40 and 80 years old.

THARROS Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Time to first severe cardiac or COPD event

Secondary outcome measures

Moderate/severe COPD exacerbation rate

Time to Heart Failure (HF) acute healthcare visit/hospitalization or cardiac death

Time to Myocardial Infarction (MI) hospitalization or cardiac death

+3 more

Other outcome measures

Serious Adverse Events (SAEs) and Adverse Events leading to discontinuation (DAEs), Adverse Events of Special Interest (AESIs) of pneumonia leading to hospitalization or death

THARROS Trial Design

2Treatment groups

Experimental Treatment

Group I: GFF armExperimental Treatment1 Intervention

GFF MDI 14.4/9.6 μg BID

Group II: BGF armExperimental Treatment1 Intervention

BGF MDI 320/14.4/9.6 μg BID

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

BGF MDI 320/14.4/9.6 μg

2015

Completed Phase 3

~11120

GFF MDI 14.4/9.6 μg

2015

Completed Phase 3

~9220

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

AstraZenecaLead Sponsor

4,271 Previous Clinical Trials

288,607,703 Total Patients Enrolled

Frequently Asked Questions

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

Which specific individuals are considered the ideal candidates for inclusion in this clinical trial?

"Individuals aged between 40 and 80 diagnosed with chronic obstructive pulmonary disease are eligible for participation in this trial, which aims to enroll a total of 5000 candidates."

Answered by AI

Are there any available positions for patients to participate in this clinical trial?

"As per the details provided on clinicaltrials.gov, this particular research endeavor is presently not in pursuit of additional participants. Although it was first listed on 2/22/2024 and updated most recently on 2/21/2024, there are currently 498 alternative clinical trials actively seeking eligible candidates for enrollment."

Answered by AI

At how many different sites is this study currently being conducted?

"At present, this research project is operating from 489 diverse sites. Some of these include Florencio Varela, Santo Andre, and Yambol among many others. Opting for the nearest clinic can reduce travel burdens when participating in this study."

Answered by AI

Has the BGF treatment regimen received official approval from the FDA?

"Based on our team's evaluation at Power, the safety rating for the BGF treatment arm in this Phase 3 trial is graded as a level 3. This grading signifies existing efficacy data along with comprehensive safety information collected over multiple assessment periods."

Answered by AI

Does this research project include individuals aged 85 and above in its patient recruitment process?

"To be considered for participation in this research project, individuals aged between 40 and 80 are eligible. It is noteworthy that there are a total of 38 investigations targeting those below the age of majority as well as 481 trials focusing on elderly individuals above 65 years old."

Answered by AI

Who else is applying?

What site did they apply to?

Research Site

Other

What portion of applicants met pre-screening criteria?

Did not meet criteria

Met criteria

Why did patients apply to this trial?

I am looking to live a fairly normal life. I am looking for a more effective medical solution to my condition.

PatientReceived no prior treatments

I'm on Albuterol and trelegy and still having several exacerbations daily.

PatientReceived no prior treatments

I have excessive mucus I believe due to my co-pd I am on two inhalers now with Sarah and albuterol they seem to help I would like to feel better than what I do now.

PatientReceived no prior treatments

Recent research and studies

clinicaltrials.govStudy

A Study Evaluating the Efficacy of Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dosed Inhaler on Cardiopulmonary Outcomes in Chronic Obstructive Pulmonary Disease

2024. "A Study Evaluating the Efficacy of Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dosed Inhaler on Cardiopulmonary Outcomes in Chronic Obstructive Pulmonary Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06283966.

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