Expiratory Airflow Limitation for Chronic Obstructive Pulmonary Disease
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to understand how and where airflow becomes blocked in the lungs of individuals with COPD, emphysema, or a combination of asthma and COPD. It examines various treatments, including inhalers (such as inhaled corticosteroids, long-acting inhaled beta2 agonists, and long-acting inhaled muscarinic receptor antagonists) and oral medications (like oral antibiotics, oral corticosteroids, and PDE type 4 inhibitors), to assess their effects on airflow. This study suits current or former smokers with at least 15 years of smoking history who experience breathing problems. Participants should not have other lung diseases, such as pulmonary fibrosis. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to early-stage treatment evaluation.
Do I need to stop my current medications to join the trial?
The trial does not specify if you need to stop your current medications. It mentions that treatment may include various inhaled medications and other treatments, so it's best to discuss with the trial coordinators.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that the treatments under study for COPD, emphysema, and asthma-COPD overlap have varying safety levels.
Inhaled corticosteroids are generally safe but may increase the risk of pneumonia in some individuals. Long-acting inhaled beta2 agonists, used since the late 1990s, are considered safe for COPD, though they may pose a risk of serious heart problems. Long-acting inhaled muscarinic receptor antagonists are well-tolerated and improve lung function without major safety concerns.
Oral antibiotics are often prescribed for lung infections, but strong evidence for their regular use in these conditions is lacking. Oral corticosteroids can cause side effects like high blood sugar but help prevent treatment failures. PDE type 4 inhibitors, such as roflumilast, are safe and help manage COPD symptoms.
Short-acting inhaled beta2 agonists are effective but have been linked to higher death rates at high doses. Short-acting inhaled muscarinic receptor antagonists are being developed to reduce side effects and enhance efficacy.
Extensive studies have provided a good understanding of these treatments' safety. However, individual experiences may vary, so discussing these options with healthcare providers is important.12345Why are researchers excited about this trial?
Researchers are excited about this trial because it aims to unravel the specific sites and mechanisms of expiratory airflow limitation in conditions like COPD, emphysema, and asthma-COPD overlap. This is significant because understanding these mechanisms could lead to more targeted and effective treatments. Unlike the current standard treatments that generally aim to relieve symptoms, this trial's focus on detailed physiological and radiological differences could pave the way for personalized therapies, improving outcomes for patients with these complex respiratory conditions.
What evidence suggests that this trial's treatments could be effective for COPD, Emphysema, and Asthma-COPD Overlap?
This trial will evaluate various treatments for managing symptoms of COPD, emphysema, and asthma-COPD overlap. Research has shown that certain inhaled medications can help manage COPD symptoms. Inhaled corticosteroids, one treatment in this trial, can lower the chances of moderate to severe flare-ups. Long-acting inhaled beta2 agonists, another option in this trial, help improve breathing and reduce symptoms. Long-acting muscarinic receptor antagonists, also studied, improve breathing and lessen the need for extra medication. PDE type 4 inhibitors, included in the trial, effectively reduce airway inflammation. Short-acting beta2 agonists provide quick relief by relaxing the muscles around the airways, while short-acting muscarinic antagonists block signals that tighten the airways. Each of these treatments has been shown to help manage symptoms of COPD, emphysema, and asthma-COPD overlap.12356
Who Is on the Research Team?
Arthur F Gelb, MD
Principal Investigator
Clin Prof Geffen School of Medicine at UCLA Medical Center
Arthur F Gelb, MD
Principal Investigator
Clin Prof Geffen School of Medicine at UCLA Medical Center
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Observational Study
Participants undergo extensive lung function testing, including spirometry, CT scans, and blood studies to evaluate expiratory airflow limitation.
Follow-up
Participants are monitored for safety and effectiveness after observational assessments
What Are the Treatments Tested in This Trial?
Interventions
- Inhaled Corticosteroid
- Long Acting Inhaled Beta2 Agonist
- Long Acting Inhaled Muscarinic Receptor Antagonist
- Oral Antibiotic
- Oral Corticosteroid
- PDE Type 4 Inhibitor
- Short Acting Inhaled Beta2 Agonist
- Short Acting Inhaled Muscarinic Receptor Antagonist
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Based on clinical, pathologic, laboratory, physiologic and radiologic differences, patient groups can be described.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Gelb, Arthur F., M.D.
Lead Sponsor
Citations
Inhaled corticosteroids in COPD: Benefits and risks
There was a lower rate of moderate and severe COPD exacerbations with triple therapy compared with UMEC/VI (RR 0.75; 95% CI, 0.70–0.81; P<0.001), as well as a ...
Rational use of inhaled corticosteroids for the treatment ...
In this article, we review the benefits and risks of ICS use in COPD, drawing on evidence from RCTs and observational studies conducted in primary care.
Adverse Outcomes Associated With Inhaled Corticosteroid ...
We have read with great interest the recent article by Pace et al. (1) addressing the adverse outcomes associated with long-term inhaled ...
Treatment with inhaled corticosteroids in chronic obstructive ...
The aim of this review was to investigate when to use ICS in COPD and to compare the effectiveness and safety of different ICSs.
a systematic review and meta-analysis: Journal of Asthma
Comparative safety and effectiveness of inhaled bronchodilators and corticosteroids for treating asthma–COPD overlap: a systematic review and meta-analysis.
Effectiveness and Safety of Inhaled Corticosteroids in Older ...
ICS was associated with fewer hospitalizations for OLD in older adults with asthma and concurrent asthma and COPD, but had little impact on OLD and pneumonia ...
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