Clinical Trials Logo
  1. Home
  2. Asthma
  3. NCT05553379
  4. Details
NCT05553379 Clinical Trial

Vivatmo proTM EU-study: FeNO Monitoring in Asthmatic Patients Responding to ICS Treatment

Asthma Clinical Trial

Official title:
Clinical Study of the Vivatmo proTM for Fractional Exhaled Nitric Oxide (FeNO) Monitoring in Asthmatic Patients Responding to Inhaled Corticosteroid (ICS) Treatment

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT05553379
Other study ID # MDQ-01.736-010-02-EBA-PAM
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date March 15, 2022
Est. completion date October 15, 2022

Study information
Verified date September 2022
Source Bosch Healthcare Solutions GmbH
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This is a multi-center study to evaluate fractional exhaled nitric oxide (FeNO) measured with the Vivatmo pro in adult and pediatric subjects.

Description:

Subjects will be screened, enrolled and tested at Study Visit #1 and then prescribed inhaled corticosteroid (ICS) treatment as per routine clinical care. Subjects will return for Study Visit #2 in two weeks and repeat fractional exhaled nitric oxide (FeNO) measured with the Vivatmo pro,

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 48
Est. completion date October 15, 2022
Est. primary completion date September 15, 2022
Accepts healthy volunteers
Gender All
Age group 7 Years to 80 Years
Eligibility Inclusion Criteria: 1. Subject is 7 to 80 years of age. 2. Has asthma 3. Has been identified as a candidate for inhaled corticosteroid (ICS) treatment 4. Is willing and able to perform Vivatmo pro™ testing Exclusion Criteria: 1. Subject has used corticosteroids prior to enrollment. 2. Subject has other current serious medical conditions 3. Subject has not been clinically stable for at least 2 weeks prior to the study 4. Subject is unwilling or unable to perform Vivatmo pro testing

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• FeNO measurement
FeNO measurement at each visit

Locations
Country Name City State
Czechia MUDr. Ingeborg Vokálova s.r.o Kralupy Nad Vltavou
Czechia Alergologie Skopkova, s.r.o Ostrava
Czechia Plicní stredisko Teplice s.r.o Teplice
Czechia MUDr. Ivan Drnek Ústí Nad Labem
Germany Kinderpneumologie und Allergologie im Facharztzentrum Mannheim

Sponsors (1)
Lead Sponsor Collaborator
Bosch Healthcare Solutions GmbH

Countries where clinical trial is conducted

Czechia,  Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in FeNO Value [Time Frame: 14 days] Change in FeNO value before and after inhaled corticosteroid treatment 14 days
See also
  Status Clinical Trial Phase
Completed NCT04624425 - Additional Effects of Segmental Breathing In Asthma N/A
Terminated NCT04410523 - Study of Efficacy and Safety of CSJ117 in Patients With Severe Uncontrolled Asthma Phase 2
Active, not recruiting NCT03927820 - A Pharmacist-Led Intervention to Increase Inhaler Access and Reduce Hospital Readmissions (PILLAR) N/A
Completed NCT04617015 - Defining and Treating Depression-related Asthma Early Phase 1
Recruiting NCT03694158 - Investigating Dupilumab's Effect in Asthma by Genotype Phase 4
Terminated NCT04946318 - Study of Safety of CSJ117 in Participants With Moderate to Severe Uncontrolled Asthma Phase 2
Completed NCT04450108 - Vivatmo Pro™ for Fractional Exhaled Nitric Oxide (FeNO) Monitoring in U.S. Asthmatic Patients N/A
Completed NCT03086460 - A Dose Ranging Study With CHF 1531 in Subjects With Asthma (FLASH) Phase 2
Completed NCT01160224 - Oral GW766944 (Oral CCR3 Antagonist) Phase 2
Completed NCT03186209 - Efficacy and Safety Study of Benralizumab in Patients With Uncontrolled Asthma on Medium to High Dose Inhaled Corticosteroid Plus LABA (MIRACLE) Phase 3
Completed NCT02502734 - Effect of Inhaled Fluticasone Furoate on Short-term Growth in Paediatric Subjects With Asthma Phase 3
Completed NCT01715844 - L-Citrulline Supplementation Pilot Study for Overweight Late Onset Asthmatics Phase 1
Terminated NCT04993443 - First-In-Human Study to Evaluate the Safety, Tolerability, Immunogenicity, and Pharmacokinetics of LQ036 Phase 1
Completed NCT02787863 - Clinical and Immunological Efficiency of Bacterial Vaccines at Adult Patients With Bronchopulmonary Pathology Phase 4
Recruiting NCT06033833 - Long-term Safety and Efficacy Evaluation of Subcutaneous Amlitelimab in Adult Participants With Moderate-to-severe Asthma Who Completed Treatment Period of Previous Amlitelimab Asthma Clinical Study Phase 2
Completed NCT03257995 - Pharmacodynamics, Safety, Tolerability, and Pharmacokinetics of Two Orally Inhaled Indacaterol Salts in Adult Subjects With Asthma. Phase 2
Completed NCT02212483 - Clinical Effectiveness and Economical Impact of Medical Indoor Environment Counselors Visiting Homes of Asthma Patients N/A
Recruiting NCT04872309 - MUlti-nuclear MR Imaging Investigation of Respiratory Disease-associated CHanges in Lung Physiology
Withdrawn NCT01468805 - Childhood Asthma Reduction Study N/A
Recruiting NCT05145894 - Differentiation of Asthma/COPD Exacerbation and Stable State Using Automated Lung Sound Analysis With LungPass Device