OVERVIEW
DCT spirometry
Clario provides industry-leading decentralized trial (DCT) spirometry solutions for hybrid and fully remote respiratory studies. These solutions allow at-home testing without compromising functionality, enabling full flow volume loops and helping sponsors generate more robust data to strengthen regulatory submissions.
For which indications is spirometry testing performed?
Spirometry is assessed for a wide range of indications where it is used as a biomarker for treatment effect, disease progression or lung safety:
- Asthma
- Chronic Obstructive Pulmonary Disease (COPD)
- Cystic Fibrosis (CF)
- Idiopathic Pulmonary Fibrosis (IPF)
- Interstitial Lung Disease (ILD)
- Neuromuscular disorders
- Non-respiratory indications where the medication is delivered through the lungs or that has a known pulmonary safety signal
SOLUTIONS FOR
DCT trials
iSpiro®
iSpiro®
Compact home spirometry solution
Clario offers DCT convenience without compromise through the iSpiro home spirometry solution. Capable of capturing full, high-resolution inhalation and exhalation data points, the advanced spirometry sensor pairs with the supplied mobile device and iSpiro app to enable pulmonary function testing at home or on-the-go.
ATS/ERS guidelines have identified coaching as a critical factor in achieving reliable spirometry data. With the iSpiro system, sponsors can leverage real-time remote video coaching, connecting patient and clinician for optimal data quality.
Solution features and benefits:
- Captures FEV1, FVC, PEF, FEF25-75, VC, IC, ERV and other metrics
- Instant test feedback and notifications bolster patient compliance
- Automatic, wireless data transfer to portal
- Centralized services can reduce variability by up to 50%
Real-time remote video coaching
OVERVIEW VIDEO
Watch a demo on how the remote coaching solution works
Clario SpiroSphere
SpiroSphere®
Hybrid home-nursing solution
Clario’s proprietary SpiroSphere device was designed for use both on-site and away from the clinic when administered by a healthcare professional. Equipped with a convenient carrying case, the portable and wireless SpiroSphere system can be used to capture complete, standard spirometry metrics in the home setting by a trained nurse or clinician.
Designed with extensive trial site feedback, the SpiroSphere device is pre-calibrated and leverages single-use, disposable pneumotach tubes to optimize patient safety. Full, high-resolution digital spirometry curves can be effortlessly uploaded to Clario’s EXPERT® platform directly from the SpiroSphere device.
Solution benefits:
- Captures FEV1, FVC, PEF, FEF25-75, VC, IC, ERV and other metrics
- Verification of full inflation as recommended by 2019 standards
- Rapid setup and automation of clinic-based elements to make at-home testing easier
- Reduced cross-contamination risk for patients than site-based systems, yet same focus on quality
- Centralization can reduce variability by up to 50%
RESOURCES
Related downloads
Medical imaging data standards, automation and analysis
The FIVC should be used as an acceptable substitute for the FVC when evaluating the FVC in neuromuscular disease; experience in a clinical trial for adult myotonic dystrophy
Relationships between same day FVC and FIVC from forced spirometry and IVC from DLCO; findings in an IPF clinical trial
Centralized DLCO services
Related solutions
Site-Based Spirometry (FEV1, FVC, PEF, etc.)
Centralized, on-site pulmonary function testing for clinical trials.
Cough and Lung Sounds
Assessment of cough frequency, cough severity and other lung sounds such as crackles or rhonchi for clinical trials.
Diffusing Capacity (DLCO)
Assessing the capacity of the lungs for effective gas transfer.
Talk to a specialist
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