Cough Studies

We have exceptional expertise in cough studies and cough monitoring.
What Vitalograph Offer
Our Experience
Objectives & Endpoints

What Vitalograph Offer

A cough study’s success depends on swift, accurate, high-quality data. The VitaloJAK® Cough Monitor provides the only fully validated system for objective measurement of cough with median sensitivity >99% and excellent integrity. Our compact, mobile monitoring system allows home-based ambulatory recording over 24 hours, allowing subjects to continue their normal daily activity while participating in your trial. Cough recordings undergo centralized, semi-automated analysis to provide quantified data.

VitaloJAK is a validated, 510k cleared and CE marked medical device system.

Our experienced teams include cough, project and data management experts. They coordinate and manage all the project essentials for the Vitalograph aspect of the study including project planning, risk assessment, budget control, tracking information, creating customizable reports, reviewing data, status updates and change control. Their aim is to ensure that your trial runs smoothly, on time, to scope and on budget.

We offer

 

Enabling the objective study of cough.

Our Experience

Highly experienced cough experts, innovative devices, our unrivalled experience is at your disposal.

The VitaloJAK® Cough Monitor has proven suitable for quantifying 24 hour cough sessions in large Phase 2 and 3 studies where other methods of cough data collection and analysis are too costly, time consuming or inconsistent. 

The system has been used for research since 2005 and in phase 2 and 3 studies globally since 2014. It has been fully validated by the specialist cough research unit at the Manchester University NHS Foundation Trust UK, through multiple phase 1 and academic research studies.

Number of studies: 38
Number of molecules assessed: 13

Total coughs counted: 11,647,124 (April 2021)

 

“Measures of both intra- and inter-rater reliability for both filtered and full-length 24-hour recordings were found to be excellent, exceeding a reliability of 0.99” 

Mines et al. Assessment of Inter- and Intra- Rater Reliability of Objective Cough Frequency in patients with Chronic Cough. European Respiratory Journal 2019; 54: Suppl. 63, PA4342

Measurement Objectives & Endpoints

The objective frequency of cough is the preferred assessment of cough in clinical trials.

We offer a robust, customizable system for the measurement and analysis of cough study data in Phase I – IV trials. The study reports can be tailored to your needs so that the primary, secondary and/or exploratory endpoints can be reviewed on a regular basis, giving you live overview of your study.

CriteriaExample Endpoints
Cough counts
  • Cough count over the 24-hour recording
  • Cough count per hourly segments
  • Including screening, baseline and treatment counts.
  • Change from baseline in awake cough frequency
Events
  • Sleep / wake events
  • Quality events

Resources

References

Visit our library of spirometry, respiratory and cough-related articles.

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Case Studies

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White Papers

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Contact Us

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