What side effects are associated with this type of intervention?

Common treatments for chronic bronchitis that aim to reduce mucus production and inflammation include mucolytics like N-acetylcysteine and erdosteine, bronchodilators such as tiotropium, and anti-inflammatory agents like inhaled corticosteroids. Known side effects of mucolytics can include gastrointestinal disturbances and, less commonly, allergic reactions. Bronchodilators like tiotropium may cause dry mouth and, in rare cases, cardiovascular events. Inhaled corticosteroids can lead to oral thrush, hoarseness, and, with long-term use, an increased risk of pneumonia.

What prior FDA approvals exist?

The FDA has approved several treatments for Chronic Bronchitis, primarily focusing on reducing inflammation and mucus production. These include bronchodilators like tiotropium and glycopyrrolate, which help open airways and reduce mucus. Anti-inflammatory agents such as inhaled corticosteroids are also commonly used. While specific treatments like RheOx, which delivers energy to airways to reduce mucus production and inflammation, are still under investigation, existing therapies aim to manage symptoms and improve lung function.

What other types of research exist?

Promising novel alternatives to RheOx for chronic bronchitis patients include: 1) Nebulized glycopyrrolate (SUN-101) delivered via the eFlow® CS nebulizer, which has shown efficacy and safety in COPD patients. 2) Erdosteine, a thiol agent with mucolytic and anti-inflammatory properties, which has demonstrated a reduction in exacerbations and hospitalizations in COPD patients. 3) Carbocysteine, another mucolytic agent, which has been effective in reducing exacerbations and improving quality of life in COPD patients. These treatments offer potential benefits in managing chronic bronchitis by targeting mucus production and inflammation.

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Procedure

RheOx Device for Chronic Bronchitis (Gala_EFS Trial)

N/A

Waitlist Available

Research Sponsored by Gala Therapeutics, Inc.

Eligibility Criteria Checklist

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

Must have

Subject is diagnosed with chronic bronchitis for a minimum of two years, where chronic bronchitis is defined clinically as chronic productive cough for three months in each of two successive years in a patient in whom other causes of productive cough have been excluded.

Subject has a cigarette smoking history of at least ten packs years.

Must not have

Subject has received chemotherapy within the past 6 months or is expected to receive chemotherapy during participation in this study.

Subject has clinically significant serious medical conditions, such as: congestive heart failure, angina or myocardial infarction in the past year, renal failure, liver disease cerebrovascular accident within the past 6 months, uncontrolled diabetes, uncontrolled hypertension or autoimmune disease.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a device called RheOx, which uses energy to treat the inner layers of the airways in patients with chronic bronchitis. The treatment involves two sessions, one for each lung, performed a few weeks apart. The goal is to see if this approach can safely help improve breathing in these patients.

Who is the study for?

This trial is for adults with chronic bronchitis for at least two years, an FEV1 between 30-80% of predicted, and a history of COPD exacerbations. They must have smoked the equivalent of ten pack-years and be able to undergo bronchoscopies. Exclusions include recent arrhythmias or lung cancer, severe other medical conditions, participation in another study within six weeks, inability to walk over 100 meters in six minutes, recent smoking or respiratory infections.

What is being tested?

The RheOx system is being tested for its safety and effectiveness in treating patients with chronic bronchitis. The study involves participants undergoing bronchoscopy procedures where RheOx will be used to potentially improve their respiratory symptoms.

What are the potential side effects?

While specific side effects are not listed here, typical risks may include those associated with bronchoscopy such as discomfort, bleeding, infection risk from the procedure itself; plus any potential reactions to medications used during the process like lidocaine.

Eligibility Criteria

Inclusion Criteria

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

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I have had chronic bronchitis for at least two years.

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I have smoked at least 10 pack-years.

Exclusion Criteria

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

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I have had chemotherapy in the last 6 months or will have it during the study.

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I have serious health issues like heart failure, recent heart attack, kidney or liver disease, stroke in the last 6 months, uncontrolled diabetes or blood pressure, or autoimmune disease.

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I have had lung cancer that hasn't fully resolved in the past 5 years.

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I have severe pulmonary hypertension.

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I am taking more than 10 mg of prednisolone or prednisone daily.

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I have severe acid reflux that isn't managed by my current treatment.

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I have had heart rhythm problems in the last two years.

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I have a serious heart muscle condition.

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I cannot walk more than 100 meters in 6 minutes.

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I have large blisters on my lung scan.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Safety Through 12 Months: Rate of Serious Adverse Events

Secondary study objectives

Clinical Utility: CAT Total Score at 12 Months

Clinical Utility: CAT Total Score at 6 Months

Clinical Utility: SGRQ Score at 12 Months

+1 more

Other study objectives

Hospitalization Rate

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: RheOx TreatmentExperimental Treatment1 Intervention

RheOx Treatment (i.e., Bronchial Rheoplasty)

0 / 12Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Chronic Bronchitis include inhaled bronchodilators, corticosteroids, and mucoactive agents. Inhaled bronchodilators, such as beta-agonists and muscarinic antagonists, work by relaxing the muscles around the airways, reducing airway resistance, and improving airflow. Corticosteroids reduce inflammation in the airways, decreasing swelling and mucus production. Mucoactive agents, like erdosteine, help thin and clear mucus, making it easier to expel. Novel treatments like RheOx deliver energy to the airways to reduce mucus production and inflammation directly. These treatments are crucial for Chronic Bronchitis patients as they alleviate symptoms, improve breathing, and enhance the quality of life.