Exhaled Nitric Oxide in Asthma Management

Suspended

• Conditions: Asthma

• Registration Number: NCT02140684
• Lead Sponsor: Research in Real-Life Ltd

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03
• Status Verified: 2014-05
• Study First Submitted: 2014-05-14
• Study First Submitted QC: 2014-05-14
• Last Update Submitted: 2014-05-14
• Study First Posted: 2014-05-16
• Last Update Posted: 2014-05-16
• Primary Completion: 2015-01
• Study Completion: 2015-01

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 400

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.
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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Research in Real Life; 🇬🇧 Cambridge, United Kingdom