What side effects are associated with this type of intervention?

Common treatments for COPD, such as inhaled corticosteroids (ICS) and long-acting beta agonists (LABA), can have side effects including oral thrush, hoarseness, and an increased risk of pneumonia. Antioxidants like N-acetylcysteine are generally well-tolerated but can cause gastrointestinal issues such as nausea and diarrhea. Omega-3 fatty acid supplementation, while generally safe, can lead to gastrointestinal discomfort, fishy aftertaste, and in high doses, an increased risk of bleeding. Patients should discuss these potential side effects with their healthcare provider to determine the best treatment plan.

What prior FDA approvals exist?

The FDA has approved several treatments for Chronic Obstructive Pulmonary Disease (COPD) that focus on reducing inflammation and improving lung function. These include bronchodilators such as short-acting beta agonists (e.g., albuterol) and long-acting muscarinic antagonists (e.g., tiotropium). Anti-inflammatory treatments like inhaled corticosteroids are also commonly used. While omega-3 fatty acids are being studied for their potential anti-inflammatory and antioxidant effects in COPD, they are not yet a standard FDA-approved treatment for this condition. Mucolytic agents like N-acetylcysteine have shown some promise in reducing exacerbations and improving mucus clearance, but their use is not universally recommended.

What other types of research exist?

Promising alternatives to increased omega-3 intake for COPD patients include: 1) Antioxidant supplements such as vitamins C and E, which have been studied for their potential to reduce oxidative stress. 2) Dietary interventions rich in fruits and vegetables, which provide a variety of antioxidants and anti-inflammatory compounds. 3) Probiotics, which may help modulate the gut-lung axis and reduce inflammation. 4) Anti-inflammatory medications targeting specific pathways involved in COPD, such as phosphodiesterase-4 inhibitors. Patients should discuss these options with their healthcare provider to determine the best individualized treatment plan.

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Omega-3 Rich Diet + Coaching for COPD

Q: What is the mechanism of action of this treatment?

Common treatments for Chronic Obstructive Pulmonary Disease (COPD) include bronchodilators, corticosteroids, and anti-inflammatory agents. Bronchodilators, such as long-acting beta-2 agonists (LABAs) and long-acting muscarinic antagonists (LAMAs), work by relaxing the muscles around the airways, making breathing easier. Corticosteroids reduce inflammation in the airways, decreasing swelling and mucus production. Anti-inflammatory and antioxidant treatments, like omega-3 fatty acids, aim to reduce oxidative stress and inflammation caused by cigarette smoke and other pollutants. These mechanisms are crucial for COPD patients as they help improve lung function, reduce exacerbations, and enhance overall quality of life.

N/A

Recruiting

Led By Nadia Hansel, MD, MPH

Research Sponsored by Johns Hopkins University

Eligibility Criteria Checklist

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

Must have

Age ≥ 40 years

Global Initiative for Obstructive Lung Disease (GOLD) Stage II-IV disease with Forced Expiratory Volume in the First Second (FEV1)/ Forced Vital Capacity (FVC) <70% and FEV1 (% predicted) <80%

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, months 1 and 2 follow up calls, 3 months and 6 months

Summary

This trial tests whether delivering omega-3 rich foods to low-income adults with COPD can improve their lung health and reduce the harmful effects of air pollution. The study focuses on people with low omega-3 intake and aims to see if dietary changes can make a difference in their respiratory health. Omega-3 fatty acids have been shown to reduce cardiovascular risk and may have beneficial effects on lung health.

Who is the study for?

This trial is for adults over 40 with COPD, who have smoked at least the equivalent of 10 pack-years. They should be in moderate to severe stages of COPD and not planning to move during the study. Participants must meet certain poverty criteria or have low omega-3 intake, and can't join if they're pregnant, breastfeeding, or unwilling to eat seafood.

What is being tested?

The OMEGA trial tests whether a diet high in Omega-3s delivered to your home can improve health outcomes for people with COPD. It also includes motivational coaching on diet. The goal is to see if these changes help reduce respiratory issues caused by air pollution.

What are the potential side effects?

Since this intervention involves dietary changes rather than medication, side effects may include possible food allergies or intolerances related to increased seafood consumption as part of the Omega-3 rich foods being introduced.

Eligibility Criteria

Inclusion Criteria

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

Select...

I am 40 years old or older.

Select...

My lung condition is moderate to very severe based on GOLD standards.

Select...

My doctor has diagnosed me with COPD.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, months 1 and 2 follow up calls, 3 months and 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, months 1 and 2 follow up calls, 3 months and 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, months 1 and 2 follow up calls, 3 months and 6 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

Change in COPD health status as assessed by the COPD assessment test

Change in COPD health status/health-related quality of life as assessed by the Clinical COPD Questionnaire health-related quality of life questionnaire

Secondary study objectives

Change in Lung Function as assessed by Forced Expiratory Volume in the First Second (FEV1)

Change in Lung Function as assessed by Forced Expiratory Volume in the First Second (FEV1) percent predicted

Change in Quality of Life as assessed by the St. George's Respiratory Questionnaire

+2 more

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Active/Intervention Treatment ArmActive Control2 Interventions

Participants will receive weekly food voucher (with a specified amount) for home delivery of omega-3 rich food (with a minimum of 4 grams of eicosapentaenoic acid (EPA) + docosahexaenoic acid (DHA) in the weekly food order) and personalized dietary coaching. Participant will also receive a single 1-hour one-on-one session (dietary motivational coaching) by a dietary coach to guide participants to consume at least 500 mg of EPA+DHA daily at the beginning of the study, followed by weekly 30-minute calls during the 12-week intervention study period.

Group II: Control Treatment ArmPlacebo Group1 Intervention

Participants will receive a voucher of weekly food voucher (with a specified amount) for home delivery. Participants in the control arm will also receive a single one-on-one session by a trained research staff member at the beginning of the study, which will be followed by weekly 30-minute calls with the participant during the 12-week intervention study period. The trained research staff member will assist with the online ordering of foods and will provide calls centered on general publicly available, guideline-based dietary recommendations without tailoring or personalization (no dietary coaching). This group will not receive guidance specifically about omega-3 fatty acids.

0 / 3Eligibility 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

Common treatments for Chronic Obstructive Pulmonary Disease (COPD) include bronchodilators, corticosteroids, and anti-inflammatory agents. Bronchodilators, such as long-acting beta-2 agonists (LABAs) and long-acting muscarinic antagonists (LAMAs), work by relaxing the muscles around the airways, making breathing easier. Corticosteroids reduce inflammation in the airways, decreasing swelling and mucus production. Anti-inflammatory and antioxidant treatments, like omega-3 fatty acids, aim to reduce oxidative stress and inflammation caused by cigarette smoke and other pollutants. These mechanisms are crucial for COPD patients as they help improve lung function, reduce exacerbations, and enhance overall quality of life.

Dynamic differences in dietary polyunsaturated fatty acid metabolism in sputum of COPD patients and controls.The pharmokinetic limitations of antioxidant treatment for COPD.Are anti-oxidant and anti-inflammatory treatments effective in different subgroups of COPD? A hypothesis.