Vivatmo Pro™ for Fractional Exhaled Nitric Oxide (FeNO) Monitoring in U.S. Asthmatic Patients

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

122 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-08

Study Completion Date

2021-04-13

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Use of fenoTRACK Device for Monitoring Changes of Fractional Exhaled Nitric Oxide (FeNO) in Uncontrolled Asthma Subjects and Controlled Asthma Subjects

NCT07228026

Asthma

RECRUITING

The Evaluation of FeNO for Predicting Response to ICS in Subjects With Non-specific Respiratory Symptoms

NCT02294279

Asthma

COMPLETED PHASE4

Fractional Exhaled Nitric Oxide (FeNO)- Test as add-on Test in the Diagnostic Work-up of Asthma

NCT06230458

Diagnosis Asthma

RECRUITING NA

FeNO After Hypoxia in Asthma Patients

NCT02391090

Asthma

COMPLETED NA

A Study to Explore the Utility of Fractional Exhaled Nitric Oxide (FeNO) Compared With Methacholine Challenge (MCC) Testing in the Assessment of Patients With Suspected But Undiagnosed Asthma

NCT01648920

Asthma

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Asthma Asthma in Children

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Test Cohort

Subjects age 7 to 80 with asthma

Group Type EXPERIMENTAL

Vivatmo pro FeNO Test

Intervention Type DIAGNOSTIC_TEST

Breath gas analysis

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Vivatmo pro FeNO Test

Breath gas analysis

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Fractional exhaled nitric oxide (FeNo)

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

7 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No