Asthma Studies

We provide high-quality customised respiratory solutions to contribute to the success of your Asthma trial.

What Vitalograph Offer
Our Experience
Objectives & Endpoints

What Vitalograph Offer

Our focus is on your study needs, and our systems are fully customisable to your requirements.

We offer a range of centralised pulmonary function testing (PFT) endpoints and customisable reports for data monitoring and analysis, and quick and easy access to subject matter experts throughout the life of your study.

We provide you with:

  • Protocol-driven customisable software that captures reversibility, serial and challenge testing, and highlights study alerts and deviations to the user.
  • NIOX VERO® centralised FeNO data capture to assess underlying inflammation.
  • Over-read service for clinic and home pulmonary function tests (PFT) providing sites with accurate feedback to ensure data quality.
  • Centralised ECG and other endpoint data to meet the needs of your study.
  • eCOA and ePRO questionnaires with accurate and reliable PEF and FEV1 measurements through our In2itiveTM e-Diary. ACT, AQ20, ACQ-5, ACQ-6 and AQLQ(S) 12+ are pre-validated on our device.
  • Clinical trial devices and software.
  • Professional and dedicated study services.

Our Experience

Choosing Vitalograph gives you the benefit of our globally renowned expertise in Asthma studies.

With extensive experience in supporting Phase I – IV, adult and paediatric Clinical Trials in Asthma, Vitalograph is the study partner of choice for many leading pharmaceutical companies and CROs.

Being a market leader in respiratory medical devices for over 50 years, we have an enviable expertise in respiratory testing and monitoring. The importance of accurate and reliable data for Asthma study objectives and endpoints is understood – we provide data you can rely on.

Pre-eminent Over-readers ensure high-quality data and feedback for your trial, improving site data, compliance and performance.

Our experienced teams of highly qualified and responsive project and data managers mean decisions can be made quickly, and enable flexibility and prompt feedback to any queries. They also ensure studies key milestones are met, and facilitate the rapid delivery of your trial.

Objectives & Endpoints

We provide accurate, reliable and precise Asthma clinical trial objectives and endpoints.

CriteriaExample Endpoints
Subjective Endpoints
  • Symptom scores
  • Rescue medication use
  • Example pre-validated eCOA and ePRO on our In2itive™ e-Diary: ACT, AQ 20, ACQ and AQLQ(S)12+
  • Custom endpoints available.
Objective Endpoints
  • In clinic PFT including:

    • FVC, FEV1/FVC ratio, FEV1 % predicted, FVC % predicted
    • Reversibility
    • Pre & post bronchodilator spirometry
    • Pre and post study drug
    • Serial and challenge testing
  • Home monitoring of FEV1 & PEF
  • FeNO

Resources

References

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Case Studies

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White Papers

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Contact Us

Speak to our team about our experience and how our services can benefit your study.