Cystic Fibrosis Studies

Respiratory solutions designed for the success of your Cystic Fibrosis study.

What Vitalograph Offer
Our Experience
Objectives & Endpoints

What Vitalograph Offer

Our focus is always on your study needs, so we work to your specific requirements. A fully customizable, centralized spirometry system helps clinicians identify and monitor Cystic Fibrosis in adults and children. 

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

 

We offer:

  • Over-read for spirometry and ECG, providing prompt feedback to sites to maintain the quality of data.
  • NIOX VERO® centralized FeNO data capture to assess underlying inflammation.
  • Home monitoring patient report outcome questionnaires and spirometry measurements.
  • eCOA and ePRO: EQ-5D-5L is pre-validated on our In2itive™ e-Diary, others can be integrated to meet study needs.
  • Customizable reports for data monitoring and analysis.
  • Access to subject matter experts throughout the life of your study.
  • Clinical trial devices and software.
  • Professional and dedicated study services.

Our Experience

Choosing Vitalograph gives you the benefit of our renowned global expertise in Cystic Fibrosis studies.   

With extensive experience in supporting Phase I – IV, adult and pediatric Clinical Trials in Cystic Fibrosis, 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 Cystic Fibrosis 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 and reliable capturing of Cystic Fibrosis clinical trial measurement objectives and endpoints.

 

CriteriaExample Endpoints
Subjective Endpoints
  • Symptom scores
  • Pre-validated eCOA on In2itive™ e-Diary e.g. EQ-5D-5L.
  • Other eCOA and questionnaires can be integrated to meet study needs.
  • Custom endpoints available
Objective Endpoints
  • PFT including:
    • In-clinic lung function tests
    • Reversibility
    • Pre & post bronchodilator spirometry
    • Serial and challenge testing
    • Pre and post drug spirometry
  • Spirometry:
    • Reversibility
    • FEV1
    • FEV1/FVC ratio
    • FEF25-75
    • FVC
    • % Predicted FVC
    • PEF
  • Home monitoring of FEV1 & PEF

  • Exacerbations / study alerts

  • 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.

Ready to Restart Spirometry Testing?

Make sure you understand the international safety guidelines for spirometry testing by downloading our 5 Key Considerations Guide and order your FREE trial pack of Bacterial Viral Filters to help you test safely.