Respiratory Solutions

Chronic obstructive pulmonary disease (COPD) is a progressive disease that makes breathing difficult and is a leading cause of mortality worldwide. Although up to half of all COPD exacerbations are not reported by patients, these aggravations worsen COPD symptoms and lung function, leading to hospitalization or death and negatively impacting a patient’s quality of life.

To obtain regulatory approval for your COPD drug, the clinical trial must demonstrate core improvement in lung function parameters or exacerbation risk. In addition, patient-rated endpoints, including breathlessness, or cough are also important factors for study success. Clario’s integrated solution will ensure you are collecting optimal data for your study’s regulatory submissions.

With recent dynamic advancements in remote data collection, Clario provides unique technologies to obtain FVC/FEV1 data from home by patients or under supervision of site personnel via remote transmission of data and video.

Clinical trials in cystic fibrosis (CF) continue to investigate new therapies, including gene therapy, anti-inflammatory drugs, and anti-infectives. This increases the challenge in identifying the right endpoints, including surrogate endpoints, to conclusively evaluate your compounds. As clinical trial patients are frequently children, getting accurate lung function data is challenging, adding to the study’s complexity.

Cystic Fibrosis is a recessive genetic disorder that affects multiple organs, including the lungs, pancreas, liver, and intestine. The dysfunctional CFTR gene impacts regulation of salts within cells which results in a range of downstream consequences such as poor mucociliary clearance, acute and chronic infection, increased inflammation and lung damage, airway obstruction and accelerated lung function decline resulting in premature mortality.
Patients often have a high burden of remedial measures which adds high levels of complexity to any trial trying to determine the add on benefit of a single new medication. Variability in testing and learning effects also drives increased complexities to try to separate out the impact of drug effect.

Cystic fibrosis patients are particularly vulnerable to cross infection which can impact disease progression and patient outcomes.

To address this concern, Clario’s home and site spirometers are specifically designed to reduce the risk of cross contamination by providing pre calibrated single use PFT sensors which reduces sensor cleaning between patients.
This wireless technology offers further advantages to allow a physical separation of patients and technicians while collecting measurements. This supports the potential for a dedicated, easily cleaned patient testing area to minimize cleaning and downtime between patients.

With recent dynamic advancements in the collection of data from home, Clario provides unique technologies to obtain FVC/FEV1 data from home by patients or under supervision of site personnel via remote transmission of data and video.

Idiopathic pulmonary fibrosis (IPF) is a chronic and progressive restrictive lung disease, characterized by an abnormal and progressive scarring of the lung and relentless decline of forced vital capacity (FVC). Endpoints such as FVC and DLCO help to characterize the loss of lung elasticity and reduction of gas exchange which are indicative of disease progression. These endpoints can be undermined by variability which can modify the drug effect and can result in failed studies.

Clario brings extensive experience from multiple IPF trials including two licensed compounds in the market.

With recent dynamic advancements in the collection of data from home, Clario provides unique technologies to obtain FVC data from home by patients or under supervision of site personnel via remote transmission of data and video.

In case of home nursing set up, Clario offers DLCO equipment for home visit.

Numerous medication mechanisms and drugs which are administered via the lung can potentially damage the lung. Non-respiratory indications, like Amyotrophic Lateral Sclerosis (ALS), Systemic Sclerosis, Crohn’s Disease, and Pompe’s Disease impair the respiratory muscles and eventually progress to respiratory dysfunction or respiratory failure and premature mortality.

Endpoints such as FVC, SVC, MIP, MEP, DLCO and LCI can be used to demonstrate drug safety and act as a biomarker for disease progression and drug effect.

Failure to control variability in these endpoints can easily result in false safety signals or premature withdrawal or missed safety signals which will impact the drugs safety profile.

Because a decline in respiratory function is a direct result of the progression of certain non-pulmonary diseases, demonstrating a treatment benefit on respiratory endpoints may provide evidence of your drug’s effectiveness. Clario enables precise lung function testing integrated with other efficacy data points like patient-reported outcomes (PRO) and more.

Clario enables precise lung function testing to measure both the drug effect and progress of the disease using purpose-built devices and software customized to your protocol workflow for nearly 100% acceptable data in real-time.

Non-Respiratory Diseases That Affect the Lungs

Indications that impair respiratory muscles and include pulmonary function testing to monitor disease progression include:

• Amyotrophic Lateral Sclerosis
• Systemic Sclerosis
• Crohn’s Disease
• Pompe’s Disease
• Duchenne Muscular Dystrophy
• Rheumatoid Arthritis
• Multiple Sclerosis
• Pulmonary Hypertension
• Graft Versus Host Disease
• Guillain-Barre Syndrome
• Myasthenia Gravis