Clinical Trials
U-Breathe Respirology is a recognized Centre of Excellence for asthma and COPD care. In addition to providing comprehensive diagnosis, treatment, and ongoing follow-up, we actively participate in international, multicenter clinical research trials to advance respiratory medicine.
Our team has contributed to multiple Phase 2 to Phase 4 clinical trials, focused on innovative COPD and asthma treatment. We continue to participate in cutting-edge research, offering patients potential access to emerging medications and therapies that are not yet widely available.
As a patient at U-Breathe Respirology, you may have the opportunity to benefit from innovative treatments through our research facility, helping to shape the future of respiratory care
Asthma Trials
U-Breathe has participated in seven phase III and phase IV trials in Asthma. We are currently participating in one phase III and two phase IV asthma drug trials. You or your patient may qualify to participate, please inquire at the clinic or asked to be referred to U-Breathe.
COPD Trials
U-Breathe has participated and completed four COPD drug research trials. We are currently actively participating in four phase III COPD drug trials. You or your patient may qualify to participate and receive treatment, please inquire at the clinic or asked to be referred to U-Breathe.
Our Research Program
Our research program has grown significantly since we participated in our first Phase IV clinical trial in 2019. Since then, we have participated in more than a dozen studies ranging from Phase IIb through Phase IV, primarily in respiratory medicine, and we remain in good standing with Health Canada.
An important part of that growth has been building the infrastructure needed to conduct research consistently, responsibly, and in accordance with regulatory requirements. Our Lead Research Coordinator has played a pivotal role in developing our SOPs and standardized documentation templates, helping establish a strong, sustainable foundation for our research program.
One of our strengths has been both patient recruitment and retention, and that success begins long before we ever approach a patient about participating in a study. We are thoughtful and selective about the clinical trials in which we participate, carefully considering whether each study is appropriate for our patient population and whether participation can reasonably serve the patient's interests. Once patients enter a study, we remain committed to maintaining that patient-centred approach throughout every stage of their participation. For us, a successful research program keeps the patient at the centre of every step, ensuring their well-being, experience, and individual needs remain a priority throughout their participation.
Drug Phase Trials
Drug Phase Trials (Legend)
Phase 1
Evaluation of pharmacology and toxicity of an investigation drug in humans.
Pharmacokinetics: Absorption, distribution, metabolism and excretion of the drug in the human body
Pharmacodynamics: Effect of the drug on the human body
Safety & Tolerability: Safe dose range of the drug for future trials
Subjects & Sample Size: Typically healthy volunteers (or sometimes seriously ill patients with no other options)
6-20 subjects typically
Design: Dose escalation, typically open-label, single center
Duration: Short, ranging from 9-18 months
Phase II
Evaluation of the safety and efficacy of an investigational drug
Focus on:
Further assessment of the safety of the drug
Assessment of the effectiveness of the drug
Determination of dose and dosage regimen of the drug to be used in later studies
Evaluation of different target populations and therapeutic regimens of the drug
Investigation of drug-drug interactions
Subjects & Sample Size: Subjects with the condition under study. 50-200 subjects having a target disease.
Design: Blinded, randomized, controlled, strict inclusion / exclusion criteria
Duration: One to three years
Phase III
Confirmation of therapeutic efficacy
Focus on:
Confirmation of therapeutic benefit
Monitoring of side effects
Dose-response relationship
Wider target population
Use at other stages of the disease
Interaction with other drugs or food
Development of instructions for use or product label
Subjects & Sample Size: Subjects with the condition under study. 200-1000 subjects
Design: Blinded, randomized, controlled, general population.
Duration: Two to five years
Phase IV
Post-approval trials that further investigate the therapeutic use of an investigational drug
Focus on:
Optimization of the drug
Monitoring of long-term adverse events
Contraindicative drugs or diseases
Drug effectiveness and drug safety in populations not studied in earlier phases of research
Further investigation of drug-drug interactions, dose-response and safety profile, epidemiology, morbidity or mortality
Subjects & Sample Size: Subjects with the condition under study. Hundreds of subjects, and subjects may be users of the drug or individuals belonging to new populations that need further investigation, such as children, the elderly, other diseases, etc.
Design: Usually blinded, randomized, controlled
Duration: One to three years or longer, if required by the regulatory authority