NCT05553379

Brief Summary

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

Trial Health

47
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
48

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2022

Shorter than P25 for all trials

Geographic Reach
2 countries

5 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 15, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2022

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

September 21, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 23, 2022

Completed
22 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2022

Completed
Last Updated

September 23, 2022

Status Verified

September 1, 2022

Enrollment Period

6 months

First QC Date

September 21, 2022

Last Update Submit

September 21, 2022

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

  • Change in FeNO Value [Time Frame: 14 days]

    Change in FeNO value before and after inhaled corticosteroid treatment

    14 days

Study Arms (2)

Children 7 to 17

Children with asthma

Diagnostic Test: FeNO measurement

Adults 18 to 80

Adults with asthma

Diagnostic Test: FeNO measurement

Interventions

FeNO measurementDIAGNOSTIC_TEST

FeNO measurement at each visit

Adults 18 to 80Children 7 to 17

Eligibility Criteria

Age7 Years - 80 Years
Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with Asthma

You may qualify if:

  • Subject is 7 to 80 years of age.
  • Has asthma
  • Has been identified as a candidate for inhaled corticosteroid (ICS) treatment
  • Is willing and able to perform Vivatmo pro™ testing

You may not qualify if:

  • Subject has used corticosteroids prior to enrollment.
  • Subject has other current serious medical conditions
  • Subject has not been clinically stable for at least 2 weeks prior to the study
  • Subject is unwilling or unable to perform Vivatmo pro testing

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

MUDr. Ingeborg Vokálova s.r.o

Kralupy nad Vltavou, 27801, Czechia

Location

Alergologie Skopkova, s.r.o

Ostrava, 70900, Czechia

Location

Plicní středisko Teplice s.r.o

Teplice, 941501, Czechia

Location

MUDr. Ivan Drnek

Ústí nad Labem, 40001, Czechia

Location

Kinderpneumologie und Allergologie im Facharztzentrum

Mannheim, 68161, Germany

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 21, 2022

First Posted

September 23, 2022

Study Start

March 15, 2022

Primary Completion

September 15, 2022

Study Completion

October 15, 2022

Last Updated

September 23, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Registration study for internal use only.

Locations

DE(1)CZ(4)