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:

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 aim of 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.
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.
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.
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.
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.