Clinical trial NCT02140684: Exhaled Nitric Oxide in Asthma Management
Official title: 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
Study type: OBSERVATIONAL
Overall status: SUSPENDED
Conditions: Asthma
Keywords: Real-world
observational
Nitric oxide
Inhaled corticosteroid
UK
Lead sponsor: Research in Real-Life Ltd
Sponsor class: NETWORK
Collaborators: name: Aerocrine AB
First posted: 2014-05-16
Enrollment: 400
Sex: ALL
Minimum age (years): 6
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Asthma patients who either:

* Use eNO monitoring in their asthma management
* Do not use eNO monitoring

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.


Eligibility criteria: 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

Primary outcomes:
measure: Severe Exacerbation Rate
timeFrame: One Year Outcome Period
measure: Proxy Asthma Control
timeFrame: One year outcome period
Secondary outcomes:
measure: Asthma Control (including SABA)
timeFrame: One year outcome
measure: Respiratory-related hospitalisations and referrals
timeFrame: One year outcome period
Other outcomes:
Locations:
city: Cambridge
country: United Kingdom
facility: Research in Real Life
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.