What side effects are associated with this type of intervention?

The most common treatments for COPD include inhaled bronchodilators, inhaled corticosteroids, and combination therapies. Inhaled bronchodilators, such as beta agonists (e.g., salmeterol) and muscarinic antagonists (e.g., tiotropium), can cause side effects like dry mouth, tremors, and palpitations. Inhaled corticosteroids (e.g., fluticasone) may lead to oral thrush, hoarseness, and an increased risk of pneumonia. Combination therapies (e.g., LABA-ICS) can combine these side effects. Theophylline, used for persistent symptoms, can cause nausea, headaches, and arrhythmias. Phosphodiesterase-4 inhibitors (e.g., roflumilast) may result in weight loss, gastrointestinal issues, and mood changes.

What prior FDA approvals exist?

FDA-approved treatments for Chronic Obstructive Pulmonary Disease (COPD) include several classes of medications such as long-acting beta-agonists (LABAs) like vilanterol and olodaterol, long-acting muscarinic antagonists (LAMAs) such as tiotropium and umeclidinium, and inhaled corticosteroids (ICS) like fluticasone. Combination therapies, which are often more effective, include LABA/LAMA combinations (e.g., umeclidinium/vilanterol) and LABA/ICS combinations (e.g., fluticasone furoate/vilanterol). These treatments aim to improve lung function, reduce exacerbations, and enhance the quality of life for COPD patients.

What other types of research exist?

Promising, novel alternatives for COPD management in 2024 include: 1) New pharmacologic agents such as dual bronchodilators (LAMA/LABA combinations) and novel anti-inflammatory drugs. 2) Advanced bronchoscopic interventions like endobronchial valve insertion for lung volume reduction. 3) Telemedicine and remote monitoring technologies to enhance patient management and adherence. 4) Multidisciplinary care models involving respiratory therapists, dietitians, and physical therapists to provide comprehensive care. 5) Personalized medicine approaches using genetic and biomarker information to tailor treatments.

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Population-Health Management for COPD (EQuiP COPD Trial)

N/A

Recruiting

Led By David H Au, MD

Research Sponsored by Seattle Institute for Biomedical and Clinical Research

Eligibility Criteria Checklist

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

Must have

Recent discharge from hospital for COPD exacerbation

Treatment for COPD without evidence of spirometry within 10 years, or no airflow obstruction on existing spirometr

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 90 days after intervention

Awards & highlights

No Placebo-Only Group

Summary

This trial tests whether clinical pharmacists can effectively manage COPD patients compared to pulmonary specialists. Specialists review patient records and send treatment recommendations to primary care providers electronically. The goal is to see if pharmacist-led management can achieve similar patient outcomes as specialist-led management.

Who is the study for?

This trial is for patients with COPD who are current smokers not on cessation aid, have had a recent exacerbation or hospital discharge due to COPD, or use inhaled corticosteroids without meeting criteria. Primary care providers at participating sites can also join.

What is being tested?

The study compares population management of COPD by pharmacists versus pulmonary specialists. Both will review patient cases and provide guideline-based recommendations through E-consults for primary care providers to act upon.

What are the potential side effects?

Since the interventions involve management strategies rather than direct medications, specific side effects are not detailed; however, outcomes like medication adherence and quality-of-life improvements are being measured.

Eligibility Criteria

Inclusion Criteria

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

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I was recently discharged from the hospital for a COPD flare-up.

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I am being treated for COPD but haven't had a lung function test in 10 years or my test shows no blockage.

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I was prescribed an inhaled corticosteroid but shouldn't have been.

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I have COPD, smoke, and am not using help to quit smoking.

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I am being treated for COPD but haven't had a lung function test in 10 years, or my lung function tests show no obstruction.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 90 days after intervention

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~90 days after intervention

This trial's timeline: 3 weeks for screening, Varies for treatment, and 90 days after intervention for reporting.

Treatment Details

Study Objectives

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

Secondary study objectives

Acceptance of Recommendations

COPD-related quality- of-life

Caregiver-incurred costs

+3 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Active Control

Group I: Pulmonologist ledActive Control1 Intervention

Pulmonologists will conduct population health management for patients with COPD

Group II: Pharmacist ledActive Control1 Intervention

Pharmacists will conduct population health management for patients with COPD

0 / 5Eligibility 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 Obstructive Pulmonary Disease (COPD) include inhaled bronchodilators and corticosteroids. Inhaled bronchodilators, such as long-acting beta-agonists (LABAs) and long-acting muscarinic antagonists (LAMAs), work by relaxing the muscles around the airways, thereby widening them and making it easier to breathe. Corticosteroids reduce inflammation in the airways, decreasing swelling and mucus production. These treatments are crucial for COPD patients as they help improve airflow, reduce symptoms, and prevent exacerbations, thereby enhancing the quality of life and reducing the need for hospitalizations. The trial involving E-consult recommendations by pulmonary specialists or clinical pharmacists aims to optimize these evidence-based treatments to ensure patients receive the most effective care.

Managing patients with recurrent acute exacerbations of chronic bronchitis: a common clinical problem.Canadian Thoracic Society recommendations for management of chronic obstructive pulmonary disease - 2007 update.Chronic obstructive pulmonary disease treatment options.