OVERVIEW
Support digital Patient-Reported Outcomes to assess lung function
Capture patient‑reported data that complements spirometry and strengthens respiratory trial endpoints
Patient‑Reported Outcomes (PROs) provide critical insight into how patients experience their disease and treatment, adding critical context to objective lung function measures. In respiratory studies such as COPD and asthma, PROs help evaluate symptom improvement and quality of life, supporting a more complete assessment of treatment efficacy and clinically meaningful benefit.
SOLUTIONS AND EXPERTISE
Easily capture clinical and daily symptom diaries
Simplify respiratory data collection with integrated spirometry and electronic Patient‑Reported Outcomes (ePROs)
Respiratory trials require both objective lung function measures and patient‑reported data to fully evaluate treatment safety and efficacy. Clario’s integrated spirometry and ePRO solutions support the collection of quantitative and qualitative endpoints within a single, coordinated workflow, enabling more accurate, reliable trial outcomes.
Home ePRO and home spirometry
Enable participants to capture spirometry and symptom data easily from home using one connected solution
Clario combines an at‑home spirometry device with the Clario Home App and integrated iSpiro App spirometry module to support collection of both PEF and FEV1 data, alongside daily symptom diaries. This single‑device approach improves usability for participants while simplifying study operations for sponsors and sites.
With this combination, you get the benefits of:
- Protocol‑driven workflows that guide participants through daily symptom diaries and spirometry assessments
- Automatic data upload to Clario’s database to support timely review and monitoring
- Reduced risk of transcription errors through direct electronic data capture
- One provisioned handheld device for all respiratory assessments
- Integrated training videos to support correct assessment completion
This approach helps maximize compliance while minimizing participant burden.
Daily symptom diary questionnaires
Collect patient‑reported respiratory symptoms using validated and licensed instruments
Clario’s respiratory ePRO solutions support standardized symptom questionnaires, including the Asthma Symptom Diary (ASD) and Asthma Daytime Symptom Diary (ADSD). Daily symptom diaries are delivered through a single, integrated workflow designed to promote ease of use, consistency, and reliable data capture throughout the study.
Built on a proven eCOA platform for respiratory trials
Rely on a proven respiratory outcomes platform backed by scientific and regulatory expertise
Clario’s integrated ePRO and spirometry capabilities support rigorous outcome assessment strategies, helping sponsors generate reliable, submission‑ready data across respiratory clinical trials and the broader eCOA ecosystem.
Our platform expertise includes:
- Multidisciplinary support from scientists, physicians, psychometric experts, statisticians, and solution specialists
- Outcome strategies aligned to study objectives and specific respiratory indications
Integrated data and regulatory support:
- Combines patient‑reported outcomes with high‑quality respiratory function data for a more complete assessment of treatment impact
- Supports endpoint development and validation aligned with global regulatory expectations, including those of the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA)
RESOURCES
Related downloads
Related solutions
Site-Based Spirometry (FEV1, FVC, PEF, and more.)
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.
eCOA Science Services
Expert guidance for capturing high-quality, regulatory compliant data from the right participants, at the right time, in clinic or at home.
FAQs
Why is it important to use both spirometry and Patient Reported Outcome data?
Spirometry is widely recognized as the gold‑standard objective method for quantifying respiratory function because it provides reproducible measurements of airflow limitation and ventilatory capacity. However, while spirometric parameters such as FEV₁ and/or PEF offer essential physiological insights, they do not capture the full extent to which respiratory disease affects a patient’s daily life, symptom burden, or functional well‑being.
When spirometry and PRO are used together, a more holistic and clinically robust characterization of respiratory health is assessed and can provide insights into the patient-journey. Objective measurements help establish the physiological impact of disease progression or therapeutic response, while PROs illuminate domains that directly affect patient functioning and overall treatment satisfaction. This integrated approach supports a richer understanding of disease burden, strengthens endpoint interpretation, and aligns with regulatory expectations emphasizing both objective and patient‑centric evidence in respiratory clinical research.
How is spirometry data used together with PRO data in clinical trials?
Researchers analyze spirometry and Patient‑Reported Outcome (PRO) data in combination to determine whether measurable physiological changes in lung function correlate with meaningful improvements from the patient’s perspective. Spirometric parameters – such as Forced Expiratory Volume (FEV₁) or Peak Expiratory Flow (PEF) – quantify changes in airflow and lung capacity with statistical precision. However, improvements in these metrics do not always translate directly into a perceptible difference in a patient’s daily respiratory experience.
By integrating PRO measures with objective spirometric results, researchers can evaluate whether statistically significant changes in objective lung function measures are associated with clinically relevant symptom relief, enhanced functional capacity, or improvements in quality of life. This combined approach provides a more comprehensive assessment of therapeutic benefit: while spirometry characterizes the physiological response to treatment, PRO data capture the patient’s subjective perception of symptom burden, treatment impact, and overall well‑being.
Is ePRO accepted by regulatory agencies like the FDA and EMA?
Electronic Patient Reported Outcomes (ePROs) are widely accepted and routinely implemented in clinical research to support the reliable collection of patient‑reported and clinician‑reported data. However, the scientific validity and regulatory acceptability of ePRO data are contingent upon the use of systems and operational processes that comply with applicable regulatory and data protection requirements.
ePRO platforms must be designed, validated, and maintained in accordance with relevant electronic records and electronic signature regulations, including U.S. FDA 21 CFR Part 11, to ensure data authenticity, integrity, confidentiality, and traceability throughout the study lifecycle. In addition, systems and procedures must adhere to applicable data privacy and protection regulations, such as the General Data Protection Regulation (GDPR), to safeguard participants’ personal data and ensure lawful, transparent data processing.
Compliance with these regulatory frameworks supports the use of Electronic Clinical Outcome Assessment (eCOA) data in regulatory submissions and facilitates acceptance by global health authorities for the evaluation of study endpoints.
How are questionnaire translations handled for global trials?
Maintaining linguistic and cultural equivalence across all versions is critical to preserving the validity, reliability, and sensitivity of the instrument, and to supporting the pooling and comparability of data across study populations.
Clario will facilitate translation services for daily symptom diaries that reflect the languages for your study locations.
How does ePRO ensure data quality and reduce bias, especially for subjective respiratory symptoms?
By enabling near real‑time data capture, the ePRO solution reduces recall bias commonly associated with paper‑based diaries and supports the reliable measurement of study endpoints throughout the trial duration.
Clario’s ePRO solutions are configurable to support protocol‑defined assessment schedules by prompting participants to complete evaluations within predefined time windows. This functionality promotes timely data entry and enhances adherence to study procedures.
All data entries are automatically date‑ and time‑stamped at the point of capture, providing an auditable record of assessment completion and supporting the traceability and integrity of clinical outcome data.
These features collectively enhance data completeness and accuracy, while minimizing the potential for retrospective or fabricated entries.