Respiratory Solutions

Selection of clinical trial endpoints is determined by the underlying disease pathology (e.g., asthma, chronic obstructive pulmonary disease, cystic fibrosis), the pharmacologic or device mechanism of action, and the primary trial objective – whether efficacy, safety, or both.

The most frequent respiratory endpoints include:

• Spirometry parameters such as forced expiratory volume in one second (FEV₁), forced vital capacity (FVC), and the FEV₁/FVC ratio serve as fundamental indicators of airway obstruction and lung function.
• Peak expiratory flow (PEF) monitors airflow limitation.
• Fractional exhaled nitric oxide (FeNO) provides a biomarker for airway inflammation, particularly in asthma.
• Diffusing Capacity of the Lungs for Carbon Monoxide (DLCO), which evaluates gas exchange efficiency.
• Lung volume metrics such as total lung capacity (TLC) and residual volume (RV) measure restrictive or hyperinflation patterns.
• Respiratory muscle strength testing includes maximal inspiratory pressure (MIP), maximal expiratory pressure (MEP), peak cough flow (PCF), and sniff nasal inspiratory pressure (SNIP). These endpoints offer insight into neuromuscular integrity and ventilatory capacity.
• Patient-reported outcomes are increasingly integrated to capture subjective dimensions of symptom burden, functional status, and overall quality of life, thereby complementing objective physiologic data and providing a holistic assessment of therapeutic benefit.

Data collection may occur both in clinical settings and at home, utilizing a range of specialized devices selected according to the endpoints of interest. Commonly employed instruments include spirometers (such as the Masterscope and Spirosphere), cough and lung sound monitoring systems, as well as devices for assessing diffusing capacity (DLCO), fractional exhaled nitric oxide (FeNO), and respiratory mechanics through oscillometry.

Clario can integrate these devices into a centralized strategy for collecting, monitoring, and storing the endpoints you need.

Collecting high-quality respiratory endpoints presents several operational and methodological challenges, particularly in obtaining accurate spirometry and diffusing capacity measurements. These complexities arise from the need to ensure precision, consistency, and compliance across diverse testing environments. Clario brings extensive experience in mitigating these risks and implementing robust strategies to address each challenge effectively.

Key considerations include ensuring data accuracy, reproducibility, and plausibility through rigorous quality control measures and standardized protocols. Proper execution of pulmonary function tests (PFTs) is critical, requiring trained personnel and adherence to established guidelines to minimize variability. Patient adherence in home-based testing introduces additional complexity, necessitating user-friendly devices, clear instructions, and remote monitoring solutions to maintain compliance.

Device heterogeneity and operator variability across sites can further impact data integrity, underscoring the importance of centralized oversight and calibration standards. Managing large, complex datasets demands advanced data management systems capable of integrating, validating, and analyzing multi-source information efficiently. Finally, the regulatory acceptance of novel digital endpoints requires proactive engagement with health authorities and alignment with evolving standards to ensure compliance and facilitate approval.