Options to control asthma by means of a newly developed FeNO device for use at home

• Conditions: J45; Asthma

• Registration Number: DRKS00029118
• Lead Sponsor: Bosch Healthcare Solutions GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-07-01
• Study Completion: 2023-11-08
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 87

Inclusion Criteria

Patients of either gender aged 18-75 years (inclusive)
- Written informed consent
- Diagnosis of asthma in the opinion of the investigator (see rational) for at least 6 months prior to visit 1
- Patients capable to use a smart phone and a digital device
- Patients owning a smartphone and willing to use it for trial purposes (installing and using the device related free-of-charge App, sending recorded data to PI via E-mail).

Exclusion Criteria

- Treatment with systemic corticosteroids and/or hospitalization for asthma exacerbation within the past 14 days prior to visit 1
- Significant, non-reversible, active pulmonary disease (e.g., COPD, cystic fibrosis, bronchiectasis, tuberculosis)
- Subjects suffering from acute upper or lower respiratory infection including common cold, influenza, or pneumonia.
- Current smokers
- Severe acute concomitant diseases during the previous 14 days prior to visit 1
- Active SARS-CoV-2 infection confirmed by positive PCR test within the past 4 weeks prior to V1
- Simultaneous participation in an investigational clinical trial
- Family relationship with operators or study personnel.

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
o formal hypothesis, as this is a hypothesis generating study. Patient and device characteristics are only reported in descriptive measures to develop a hypothesis for a planned confirmatory study.

Secondary Outcome Measures

Name	Time	Method
not applicable