Clinical Trials

Clinical Trials

Advancing medical knowledge

 

Winchester District Memorial Hospital’s (WDMH) research program launched its first clinical trial to benefit patients in the fall of 2022. This is a major advancement in our research program. Clinical trials are a key research tool for advancing medical knowledge and patient care. The knowledge gained will support the treatment we will provide in the years to come.


Clinical trials can provide positive impacts for many patients in the future, offering benefits such as new treatments or better drug options. Through rigorous testing, evidence-based trials ensure the solutions are safe and effective before they are used in clinical practice. 

 

WDMH has an extensive referral network to support our research:

 research network

 

 

Osteoarthritis MARS - GSK

 

Osteoarthritis (OA) is a chronic, degenerative condition that affects both the large and small joints in the body, and is the most common form of adult arthritis. Both the prevalence and impact of the disease are steadily increasing worldwide, thus alleviating the chronic pain associated with OA is currently a major unmet need.  

CCL17 is a chemokine that has been recently identified as a peripheral mediator of inflammatory pain. GSK3858279 is a human monoclonal antibody that binds to CCL17, and prevents its expression, potentially helping to alleviate the chronic pain associated with OA.

The purpose of this Phase 2 study is to investigate the efficacy, safety, PK, TE and dose exposure-efficacy relationship of GSK3858279, and to provide the data necessary to select the optimal effective and safe dose(s) of GSK3858279 to be carried forward into Phase 3 studies in subjects with knee/hip OA.


Atherosclerosis POSEIDON - NovoNordisk



The role of inflammation in atherosclerosis has been well established, and atherosclerosis is currently considered a hybrid disease between a metabolic disorder and chronic systemic inflammation. There is also evidence showing a link between systemic inflammation and risk of cardiovascular complications. C-reactive protein (CRP) has been shown to be a reliable measure of underlying systemic inflammation and a strong predictor of future cardiovascular events.  
This study will use a cross-sectional approach and conduct testing in a large sample of patients to better understand the prevalence of systemic inflammation in patients with atherosclerotic cardiovascular disease or heart failure.  

OBERON - AstraZeneca


Chronic obstructive pulmonary disease (COPD) refers to two conditions in which your airways become constricted, or “blocked”: obstructive chronic bronchitis, and emphysema. With bronchitis, your airways become inflamed and filled with a thick, sticky mucus. In cases of emphysema, the air sacs within your lungs are unable to effectively exchange oxygen and carbon dioxide. These conditions can occur separately or together, and can cause many debilitating symptoms.

Interleukin-33 is a protein which is expressed by the cells in your lungs, in response to cell injury (eg. respiratory viral infections). This protein increases mucus production, inflammation, and increases the number of cells capable of producing mucus. In patients with COPD, this protein expression is increased. This leads to mucus induced airway obstruction, and increased risk of COPD exacerbations. Tozorakimab is a treatment that binds to these proteins, and blocks their ability to work. By blocking the signalling of this protein, it has the potential to disrupt the cycle of inflammatory structural damage in lungs of patients with COPD, and thereby provide symptom relief and management for patients with COPD.

The purpose of this Phase III study is to evaluate the efficacy and safety of Tozorakimab given subcutaneously every 8 weeks and every 4 weeks, in adult participants with symptomatic COPD and history of ≥ 2 moderate or ≥ 1 severe exacerbation of COPD in the previous 12 months.

GARDEN-TIMI - Pfizer


Heart failure is a condition in which the heart’s ability to contract is impaired. This dysfunction leads to shortness of breath, or exertional limitations that impair a patient’s ability to perform day to day activities. It is generally a chronic progressive condition, which can be stabilized with medications and/or therapeutic devices, or can progress to requiring a heart transplant. The primary goals of heart failure treatment are the prevention of disease progression, symptom relief, and prevention of cardiac-related mortality.

In healthy individuals, GDF-15 a protein that is expressed and secreted at low concentrations by a range of cell types. In response to acute and cellular stressors, such as inflammation and oxidative stress, levels of GDF-15 increase. GDF-15 concentrations are significantly elevated in patients with heart failure, among many other chronic conditions. High concentrations of GDF-15 is correlated with symptom severity, functional status, and exercise tolerance, in addition to predicting an increased risk of death in patients with heart failure. It is hypothesized that ponsegromab may neutralize effects of GDF-15, and thereby improve symptoms in HF patients.

The primary purpose of this study is to assess the effect of repeated administration of ponsegromab on frequency, severity, and burden of symptoms, as well as effects on physical limitations in participants with heart failure.

LITHOS - AstraZeneca


Asthma is a respiratory disease that is characterized by chronic airway inflammation and bronchial hyperreactivity. It presents with a wide range of symptoms, such as wheezing, shortness of breath, chest tightness, and coughing. These symptoms can vary both over time and in intensity. The long-term goals of asthma management are risk reduction and symptom control. The aim is to reduce the patient burden and risk of asthma-related death, exacerbations, airway damage, and medication side effects.

This study will evaluate the efficacy and safety of a Budesonide and Formoterol Fumarate Inhaler (BFF MDI) used twice daily, compared with a Budesonide inhaler, both used over 12 weeks. The study population will consist of adult and adolescent participants with asthma who remain inadequately controlled, despite treatment with low dose inhaled corticosteroid (ICS) or ICS/long-acting beta2-agonist (LABA). The primary purpose of this study is to assess the benefits and safety of BFF MDI on both lung function and asthma health-related quality of life.

HERMES - NovoNordisk


Heart failure (HF) affects approximately 2% of the adult population in developed countries, and approximately 64.3 million patients worldwide. Most patients with HF have a range of symptoms, including difficulty breathing, and fatigue. HF causes substantial mortality and morbidity and has major effects on physical function and quality of life.

Ziltivekimab is a human monoclonal antibody that works by reducing inflammatory responses within the body. Ziltivekimab has the potential to reduce inflammation in patients with HF, and consequently may reduce symptoms, as well as long-term morbidity and mortality.

The current study is to demonstrate the efficacy of ziltivekimab in reducing morbidity and mortality in patients with heart failure (HF) with mildly reduced ejection fraction (HFmrEF) or HF with preserved ejection fraction (HFpEF) and systemic inflammation.
  

E-Coli Vaccine Trial - Janssen

 

E-Coli is a very common bacteria, and is the number one cause of Urinary Tract Infections (UTIs). Left untreated, and especially in older adults, this bacteria can progress further into the internal organs and blood stream, leading to systemic bacterial infection. Once the bacteria travels into the bloodstream and internal organs, it requires the use of complex IV antibiotics to treat. However, E-Coli bacteria is becoming highly resistant to most commonly-used antibiotics. This antibiotic resistance can lead to treatment failure, increased hospitalization, morbidity, and mortality rates, and increased healthcare costs.

This study will focus on patients 65+ with recurrent UTIs, who will receive an E-Coli vaccine, to determine whether the vaccine will help to provide protection from E-Coli bacteria, and prevent the systemic bacterial infections that can occur. The development of an E-Coli vaccine will prevent over-use of antibiotics, which in turn will minimize the development of antibiotic resistance.

 

Atrial Fibrillation - Incarda 

Atrial fibrillation (AFib) occurs when the upper two chambers of your heart beat irregularly, or inefficiently, which means that blood is unable to flow into the lower chambers of your heart as well as it should. AFib is the most common cardiac arrhythmia seen in clinical settings, with an estimated global prevalence of 33.5 million people. In patients with AFib, systemic blood clots, unstable blood pressure, decreased blood flow, and ventricular arrhythmias contribute to a significant increase in morbidity, mortality, and frequent hospitalizations. 

 

This study is a double-blind study, designed to assess the efficacy of flecainide acetate inhalation in converting atrial fibrillation to a normal heart rhythm, in patients with recent-onset, symptomatic, newly diagnosed or paroxysmal AFib. It will also evaluate the effects of flecainide acetate inhalation solution and placebo on the time to conversion of AFib to normal heart rhythm, AFib-related symptoms, hospitalizations, AFib-related interventions, and the time to discharge. 

  

 

If you would like to participate in any of our future research studies or would like any information on our current projects, please contact our research department at research@wdmh.on.ca.


CLINICAL TRIALS UNDERWAY -
NO LONGER ENROLLING PATIENTS

 

COVID Relapse  - Pfizer

 

Paxlovid has been shown to be a safe and effective treatment for mild to moderate COVID-19. However, in some people whose immune systems are compromised, the current 5-day treatment of Paxlovid might not be long enough to fully clear the virus from their body.

 

Immunocompromised patients are at a higher risk for complications and severe symptoms and are also at a higher risk for developing treatment-resistant strains. Some immunocompromised patients are experiencing a “rebound” in Covid-19 symptoms, where their symptoms return after they have recovered and tested negative.

This study is a double-blind study, to assess the safety and efficacy of a second, 5-day treatment course of Paxlovid.  It will focus on patients over the age of 12, who have completed their initial treatment course but have had a reoccurrence of symptoms within two weeks.

 

COVID Treatment - Pfizer

 

In a healthy individual, the immune system works to clear the body of any viral or bacterial infections. However, certain conditions, medications, or diseases can cause the immune system to become compromised, or suppressed.

 

Immunocompromised patients with COVID-19 are at a higher risk of developing severe infections, due to a decreased immune response, a higher viral load within the body, and the increased potential for treatment-resistant strains to develop. This increased potential for the emergence of new variants puts the general population at risk.

 

Paxlovid is an approved treatment for mild-moderate COVID symptoms in adults and pediatric (12+) patients, but for immunocompromised patients, the current 5-day treatment protocol may not be long enough to fully clear the virus from the body. This study will explore the efficacy and safety of various treatment lengths, to determine the most effective and safe protocol for use within immunocompromised populations.

 

Heart Disease - Pfizer

 

This is a three-year clinical trial looking at heart disease. Heart disease is currently the second leading cause of death within Canada, with an estimated 750,000 Canadians living with heart failure. In rural areas specifically, patients with heart failure may have a harder time accessing necessary medical services.


WDMH is part of an international study to look at the prevalence of Transthyretin Amyloid Cardiomyopathy (ATTR-CM), which is the stiffening and thickening of the heart muscle.  ATTR-CM leads to heart muscle dysfunction, cardiomyopathy, congestive heart failure, and death. It is believed that ATTR-CM is significantly underdiagnosed.  


The primary purpose of this study is to assess how common ATTR-CM is among patients with heart failure, to estimate the global prevalence of ATTR-CM. Knowing how prevalent the disease is will allow for further investigation into early diagnosis and treatment.