Exhaled Nitric Oxide in Asthma Management

Exhaled Nitric Oxide in Asthma Management: a Retrospective Real-life Observational Evaluation of the Use of Exhaled Nitric Oxide Measurements for Asthma Management in a UK Primary Care Population

Status

Suspended

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02140684

Enrollment

400

Registered

2014-05-16

Start date

2012-03-31

Completion date

2015-01-31

Last updated

2014-05-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma

Keywords

Real-world, observational, Nitric oxide, Inhaled corticosteroid, UK

Brief summary

This study will compare the absolute and relative effectiveness of managing real-life asthma with and without the use of NIOX MINO® and NIOX Flex® to measure exhaled nitric oxide (eNO) as a marker of underlying airway inflammation to guide appropriate management. As exhaled nitric oxide responds rapidly to environmental changes and can act as a marker of underlying inflammation it is proposed that incorporating eNO monitoring into routine asthma management treatment allows strategies to be more accurately tailored to the patients needs, increasing the probability of good asthma control.

Interventions

DEVICEeNO monitoring

Patient undergoing review with eNO monitored using either NIOX MINO® and NIOX Flex®

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

6 Years to 80 Years

Healthy volunteers

Inclusion criteria

1. Aged: 6-80 years 2. Evidence of active asthma (diagnostic code and/or ≥6 prescriptions for asthma therapy at any time in their records) 3. Evidence of current asthma treatment (≥2 asthma prescriptions during baseline year and outcome year) 4. Have at least one year of up-to-standard (UTS) baseline data and at least one year of UTS outcome data (following the IPD)

Exclusion criteria

1. Had a COPD read code at any time; and/or 2. Had any chronic respiratory disease, except asthma, at any time; and/or 3. Patients on maintenance oral steroids during baseline year 4. Smoker or ex-smoker aged over 60

Design outcomes

Primary

Measure	Time frame	Description
Severe Exacerbation Rate	One Year Outcome Period	Where exacerbations are defined as an occurrence of: Unscheduled hospital admissions / Emergency Room attendance for asthma, OR Use of acute courses of oral steroids
Proxy Asthma Control	One year outcome period	1. No recorded hospital attendance for asthma, including admission, Emergency Room (ER) attendance or Out-Patient Department (OPD) attendance, AND 2. No prescriptions for acute courses of oral steroids, AND 3. No GP consultations, hospital admissions or ER attendance for lower respiratory tract infections (LRTI) requiring antibiotics.

Secondary

Measure	Time frame	Description
Asthma Control (including SABA)	One year outcome	Proxy asthma control (defined above), including the absence of average daily prescribed dose of ≤200mcg salubtamol / ≤500mcg terbutaline
Respiratory-related hospitalisations and referrals	One year outcome period	Mean number of respiratory-related hospitalisations and referrals per patient during the outcome year

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026