Options to control asthma by means of a newly developed FeNO device for use at home
Organizational Data
- DRKS-ID:
- DRKS00029118
- Recruitment Status:
- Recruiting complete, study complete
- Date of registration in DRKS:
- 2022-07-01
- Last update in DRKS:
- 2023-12-19
- Registration type:
- Prospective
Acronym/abbreviation of the study
No Entry
URL of the study
No Entry
Brief summary in lay language
During the 12-week trial period patients will visit their pertinent site at the beginning (visit 1), and at least 12 weeks after visit 1 (visit 4). Visit 2 and visit 3 could be remote contacts. From visit 1 patients will perform FeNO home measurements and continue to take their currently prescribed asthma treatment. Also, they will record their daily symptoms, use of asthma medication, potential exacerbations and PEF in the device associated app. Visit 2 and 3 can be performed remote or onsite. The patient data file from the app will be reviewed and treatment adaptations of the asthma might be implemented. In case visit 3 is performed onsite, patient’s asthma control will be assessed again via the completion of ACQ questionnaire. The study will end at visit 4 after 12 weeks with a final assessment of asthma control, symptoms, and lung function.
Brief summary in scientific language
No 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. In this study, three (3) groups as well as group specific and global questions will be described. Depending on the results, specific target groups of asthmatics will then be identified, which could be part of a following prospective study. Besides the objectives presented before additional items will be investigated such as - Patient compliance while using the device - Variability of FeNO values over a longer period - Patient behaviour during stable/unstable phases - Correlation of FeNO values with symptoms - Patient and physician benefits regarding treatment adjustment and diagnostic reliability - Identification of asthma triggers The following groups will be assessed: Group 1 - According to GINA step 1: Patients may be on SABA only but not on regular ICS. However, reliever may contain ICS - Degree of control: Controlled (ACQ <0.75 or ACT ≥20) or partially controlled (ACQ 0.75-1.5 or ACT 16-19) It is expected that the study results might allow the following in this group: - Does FeNO@home provide information about uncontrolled inflammation beyond the pure symptoms that may lead to an adjustment of the asthma therapy by the physician? - Does FeNO@home support the physician in correctly diagnosing asthma in this group? Group 2 - GINA step 2-3 (ICS maintenance) - Degree of control: Controlled (ACQ <0.75 or ACT ≥20) or partially controlled (ACQ 0.75-1.5 or ACT 16-19) It is expected that the study results might allow to answer the following questions in this group: - Is the AUC FeNO lower under ICS maintenance therapy - Does FeNO@home provide information about uncontrolled inflammation beyond the pure symptoms that may lead to an adjustment of the asthma therapy by the physician? - Does the regular FeNO@home measurement provide additional information to the physician doctor to adapt the asthma treatment e.g., step down in case of FeNO<25 ppb or step up in case of FeNO>25 ppb)? - Does the FeNO@home measurement support the identification of compliance issues to inhaled therapy compared to persisting or refractory inflammation? Group 3 - GINA step 4-5, severe asthma - Degree of control: Uncontrolled (ACQ >1.5 or ACT ≤15) It is expected that the study results might allow to answer the following questions in this group: - Does the regular FeNO@home measurement provide additional information to the physician to adapt the asthma treatment e.g., step down in case of FeNO<25 ppb or step up in case of FeNO>25 ppb)? - Does the FeNO@home measurement support the identification of compliance issues to inhaled therapy compared to persisting or refractory inflammation? In addition, data are expected that might answer the following questions: - Is there a correlation between symptoms (ACQ, ACT) and FeNO values? - Is there a correlation between FeNO variability and ICS dose? - Does FeNO@home have an influence on step-up / step-down treatment measures or other measure (e.g., MART) - Do changes in FeNO@home data precede symptomatic changes or exacerbations (infections, allergen exposure)? - Are there behavioral changes of patients and physicians due to the knowledge of daily FeNO@home values? - Can the FeNO progression values be used to support a suspected diagnosis of seasonal or other allergens exposed to? - Does FeNO@home facilitate the detection of type 2 inflammation in asthmatics compared to periodic, single measurement at site?
Health condition or problem studied
- ICD10:
- J45 - Asthma
- Healthy volunteers:
- No
Interventions, Observational Groups
- Arm 1:
- Volunteers with asthma who meet the eligibility criteria. During the 12-week study phase, patients will visit their appropriate center initially (Visit 1) and at least 12 weeks after Visit 1 (Visit 4). Visit 2 and Visit 3 could be remote contacts. Beginning at Visit 1, patients will perform FeNO measurements at home and continue to take their currently prescribed asthma treatment. They will also record their daily symptoms, asthma medication use, possible exacerbations and PEF in the app connected to the device. Visit 2 and 3 can be conducted remotely or on-site. The patient data file from the app is reviewed and asthma treatment adjustments can be implemented. If visit 3 is conducted onsite, the patient's asthma control will be reassessed by completing ACQ and ACT questionnaires. The study concludes at visit 4 after 12 weeks with a final assessment of asthma control, symptoms and lung function.
Endpoints
- Primary outcome:
- No 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:
- not applicable
Study Design
- Purpose:
- Prognosis
- Retrospective/prospective:
- Prospective
- Study type:
- Non-interventional
- Longitudinal/cross-sectional:
- No Entry
- Study type non-interventional:
- No Entry
Recruitment
- Recruitment Status:
- Recruiting complete, study complete
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
-
- Germany
- Italy
- United Kingdom
- Number of study centers:
- Multicenter study
- Recruitment location(s):
-
- Doctor's practice Wiesbaden
- Medical center Centro di Medicina Personalizzata: Asma e Allergologia Mailand
- Doctor's practice Hamburg
- Doctor's practice Bonn
Recruitment period and number of participants
- Planned study start date:
- 2022-07-14
- Actual study start date:
- 2022-10-05
- Planned study completion date:
- 2023-11-08
- Actual Study Completion Date:
- 2023-11-08
- Target Sample Size:
- 120
- Final Sample Size:
- 87
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- 18 Years
- Maximum Age:
- 75 Years
- Additional 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.
Addresses
Primary Sponsor
- Address:
- Bosch Healthcare Solutions GmbHDr. Sandra WegnerStuttgarter Straße 13071332 WaiblingenGermany
- Telephone:
- +49 151 54335292
- Fax:
- +49 711 811-5184239
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.bosch-healthcare.com
- Investigator Sponsored/Initiated Trial (IST/IIT):
- No
Contact for Scientific Queries
- Address:
- insaf Institut für Atemwegsforschung GmbHDr. Kai-Michael BeehBiebricher Allee 3465187 WiesbadenGermany
- Telephone:
- +49 (0) 611 9854410
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Contact for Public Queries
- Address:
- Privatpraxis für PneumologieBiebericher Allee 3465187 WiesbadenGermany
- Telephone:
- 0611-9854347
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Principal Investigator
- Address:
- insaf Institut für Atemwegsforschung GmbHDr. Kai-Michael BeehBiebricher Allee 3465187 WiesbadenGermany
- Telephone:
- +49 (0) 611 9854410
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Sources of Monetary or Material Support
Commercial (pharmaceutical industry, medical engineering industry, etc.)
- Address:
- Bosch Healthcare Solutions GmbHStuttgarter Straße 13071332 WaiblingenGermany
- Telephone:
- +49 151 54335292
- Fax:
- +49 711 811-5184239
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.bosch-healthcare.com
Ethics Committee
Address Ethics Committee
- Address:
- Ethik-Kommission der Landesärztekammer HessenHanauer Landstraße 15260314 Frankfurt am MainGermany
- Telephone:
- +49-69-97672209
- Fax:
- +49-69-97672377
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Vote of leading Ethics Committee
- Vote of leading Ethics Committee
- Date of ethics committee application:
- 2022-01-21
- Ethics committee number:
- 2022-2817-evBO
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2022-06-22
Further identification numbers
- Other primary registry ID:
- No Entry
- EudraCT Number:
- No Entry
IPD - Individual Participant Data
- Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
- No
- IPD Sharing Plan:
- No Entry
Study protocol and other study documents
- Study protocols:
- No Entry
- Study abstract:
- No Entry
- Other study documents:
- No Entry
- Background literature:
- No Entry
- Related DRKS studies:
- No Entry
Publication of study results
- Planned publication:
- No Entry
- Publikationen/Studienergebnisse:
- No Entry
- Date of first publication of study results:
- No Entry
- DRKS entry published for the first time with results:
- No Entry
Basic reporting
- Basic Reporting / Results tables:
- No Entry
- Brief summary of results:
- No Entry