Telemonitoring of pulmonary function in patients with Cystic Fibrosis

• Conditions: CF; Fibrocystic Disease of Pancreas; Mucosis; Mucovicidosis; Pancreatic Fibrosis; 10024970

• Registration Number: NL-OMON31622
• Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 11 June 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 28

Inclusion Criteria

* Age 18 years or older
* Male or female
* Diagnosis of CF confirmed by sweat-test and/or DNA analysis and/or
electrophysiology testing
* Stable disease
* Signed written informed consent.

Exclusion Criteria

*Placing on the High Urgency waiting list for lung transplantation

Study & Design

• Study Type: Observational non invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>* Number of severe exacerbations; a severe exacerbation is defined as an<br /><br>exacerbation which requires<br /><br>treatment with intravenous antibiotic therapy, at the discretion of the<br /><br>treating lung physician.<br /><br>* Number of moderate exacerbations; a moderate exacerbation is defined as<br /><br>exacerbation which allows<br /><br>treatment with oral antibiotic therapy, at the discretion of the treating<br /><br>lung physician.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>* Quality of life, assessed with EQ-5D and Cystic Fibrosis Questionnaire (CFQ).<br /><br>* Number and route of oral or intravenous antibiotic treatment<br /><br>* Number of emergency room visits in case of suspicion of pulmonary exacerbation<br /><br>* Compliance/adherence with self-testing spirometry assessed with a compliance<br /><br>survey</p><br>