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Managing risk and generating high-quality data is particularly difficult in respiratory clinical trials. Complex protocols, lack of training, and inconsistencies in lung function parameter collection and analysis create uncertainty about patient eligibility, safety, and compound efficacy.

Fully compliant with the 2019 ATS/ERS standards, Clario is driving a new era of data quality by reducing the incidence of implausible data and changes in function associated with suboptimal coaching.

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 by site personnel via remote transmission of data and video.

To address the challenges in Respiratory Trials, Clario utilizes its Active Indication management (AIM) that goes beyond respiratory diagnostics testing. By partnering with Clario, you get much more than technology to measure lung function.

AIM methodology includes the following main pillars:

Site selection

Historic site performance if utilized during the feasibility process ensures optimal data quality and successful recruitment resulting in on-time LSLV

Customized software and workflow

Software customization with true integration of the latest ATS/ERS guidelines ensuring compliance with protocol requirements

User training

Targeted and therapy area-focused training ensures sites understand objectives of the clinical trial, which ultimately minimizes user variability and optimizes data collection

Data quality review

Centralized monitoring and quality review of data collection at the study sites and within the home setting reduces variability and facilitates optimal data collection

Data analysis

Clario´s analytics identify implausible data and trigger root cause analysis in a timely manner, which supports expected study power goals and proper treatment effects

Asthma is a chronic inflammatory airway disorder characterized by episodes of instability and variable symptoms that new medications are attempting to improve. Variability can also arise from poor compliance to protocols; medication compliance; learning effects and, to a large extent, through poor patient coaching during testing. It is essential to eliminate this artificial variability as this can modify an individual’s treatment response, making it difficult to understand which patients respond best to therapy. Uneven distribution of these artificial elements of variability can result in failed studies, inaccurate or inappropriate selection of the development dose which drives considerable delays or an inappropriate end to drug development. Clario has developed a range of services to identify inappropriate variability and drive better primary data quality. Reduction in implausible data and the provision of accurate treatment data is key to streamlining trials, improving statistical power and driving increased regulatory confidence in your data.

Asthma, a reactive airway disease, is not easily defined, nor is there a standard primary endpoint for the assessment of a treatment’s efficacy on asthma. A range of clinical trial endpoint measurements can be used, such as lung function measurements including forced expiratory volume in one second (FEV1) and peak expiratory flow (PEF). Home spirometry monitoring is key in capturing exacerbation endpoints and generating automated notifications.

Capturing pulmonary function test data along with symptoms of asthma exacerbations, like breathlessness, chest pain, cough, and wheezing helps improve patients’ quality of life. Clario’s integrated solution will ensure you are collecting optimal data for your study’s regulatory submissions.

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.

 

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

Supporting Devices

Trial Anywhere: iSpiro® Home Spirometry

Empowering the next generation of decentralized clinical trials with Clario’s iSpiro home spirometry device and virtual visit integrated platform

Option 1: Home Spirometry

(self-coached assessment)

iSpiro
iSpiro App provides
  • Tutorial video before spirometry
  • Short instuctions and feedback considering cough, late peak flow, BEV, plateau, 6s exhalation, repeatability
  • Automanic deselection of loops for cough and BEV
  • Optional: Clinical OverRead and plausibility checks, outlier assessments

Option 2: Virtual Site Visit

(site operator video coached assessment)

iSpiro on computer and mobile
Scheduling of remote visit via Clario Portal
  • Nurse guides and coaches through the test via live video
  • Display of real time spirometry signal
  • Instant quality feedback via Clario portal
  • Automatic deselection of loops for cough and BEV
  • Optional: Clinical OverRead and plausibility checks, outlier assessments

Why choose Clario respiratory?

Certainty at study start

  • Over 50 years of training, technology and process insights in diagnostics and home monitoring for Spirometry, FeNO, DLCO, LCI, FOT, ECG and eCOA
  • Visibility into almost every protocol and decades of regulatory excellence
  • Rapid study configuration and custom workflows for compliance, site satisfaction and patient performance

Real-time insights throughout

  • Virtually 100% acceptable data, trial after trial
  • Over 220 million flow volume loops analyzed
  • Central OverRead and enhanced business intelligence (BI) to identify risk, ensure site performance and deliver quality data

Confidence in results

  • Multi-protocol, multi-language, global trails
  • Always rescuing studies, never rescued
  • Supported 90% of recent regulatory approvals
  • Over 1,000+ trials at more than 68k sites

Talk to a specialist

Our team of experts is available to address questions you may have about our integrated respiratory solutions. Submit your contact information and we’ll be in touch shortly.