NCT02140684

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.

Trial Health

33
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Trial recruitment is currently suspended
Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2012

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
suspended

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 1, 2012

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

May 14, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 16, 2014

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
Last Updated

May 16, 2014

Status Verified

May 1, 2014

Enrollment Period

2.8 years

First QC Date

May 14, 2014

Last Update Submit

May 14, 2014

Conditions

Asthma

Keywords

Real-worldobservationalNitric oxideInhaled corticosteroidUK

Outcome Measures

Primary Outcomes (2)

  • Severe Exacerbation Rate

    Where exacerbations are defined as an occurrence of: Unscheduled hospital admissions / Emergency Room attendance for asthma, OR Use of acute courses of oral steroids

    One Year Outcome Period

  • Proxy Asthma Control

    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.

    One year outcome period

Secondary Outcomes (2)

  • Asthma Control (including SABA)

    One year outcome

  • Respiratory-related hospitalisations and referrals

    One year outcome period

Study Arms (2)

eNO monitoring

Patients undergoing eNO monitoring at the index prescription date

Device: eNO monitoring

No eNO monitoring

Interventions

eNO monitoringDEVICE

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

eNO monitoring

Eligibility Criteria

Age6 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Asthma patients who either: * Use eNO monitoring in their asthma management * Do not use eNO monitoring

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research in Real Life

Cambridge, CB24 3BA, United Kingdom

Location

Related Publications (4)

  • Clancy RM, Amin AR, Abramson SB. The role of nitric oxide in inflammation and immunity. Arthritis Rheum. 1998 Jul;41(7):1141-51. doi: 10.1002/1529-0131(199807)41:73.0.CO;2-S. No abstract available.

    PMID: 9663469BACKGROUND

  • Baraldi E, Carra S, Dario C, Azzolin N, Ongaro R, Marcer G, Zacchello F. Effect of natural grass pollen exposure on exhaled nitric oxide in asthmatic children. Am J Respir Crit Care Med. 1999 Jan;159(1):262-6. doi: 10.1164/ajrccm.159.1.9804063.

    PMID: 9872848BACKGROUND

  • Piacentini GL, Bodini A, Costella S, Vicentini L, Peroni D, Zanolla L, Boner AL. Allergen avoidance is associated with a fall in exhaled nitric oxide in asthmatic children. J Allergy Clin Immunol. 1999 Dec;104(6):1323-4. doi: 10.1016/s0091-6749(99)70031-x. No abstract available.

    PMID: 10589019BACKGROUND

  • Bukstein D, Luskin AT, Brooks EA. Exhaled nitric oxide as a tool in managing and monitoring difficult-to-treat asthma. Allergy Asthma Proc. 2011 May-Jun;32(3):185-92. doi: 10.2500/aap.2011.32.3449. Epub 2011 Apr 8.

    PMID: 21477457BACKGROUND

Related Links

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
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
NETWORK
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
David Price

Study Record Dates

First Submitted

May 14, 2014

First Posted

May 16, 2014

Study Start

March 1, 2012

Primary Completion

January 1, 2015

Study Completion

January 1, 2015

Last Updated

May 16, 2014

Record last verified: 2014-05

Locations

GB(1)