Exhaled Nitric Oxide in Asthma Management

NCT ID: NCT02140684

Last Updated: 2014-05-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

SUSPENDED

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-03-31

Study Completion Date

2015-01-31

Brief Summary

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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

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Conditions

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Asthma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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eNO monitoring

Patients undergoing eNO monitoring at the index prescription date

eNO monitoring

Intervention Type DEVICE

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

No eNO monitoring

No interventions assigned to this group

Interventions

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eNO monitoring

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

6 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Aerocrine AB

INDUSTRY

Sponsor Role collaborator

Research in Real-Life Ltd

NETWORK

Sponsor Role lead

Responsible Party

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David Price, Prof., MD

David Price

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Research in Real Life

Cambridge, , United Kingdom

Site Status

Countries

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United Kingdom

References

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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.

Reference Type BACKGROUND
PMID: 9663469 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9872848 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10589019 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21477457 (View on PubMed)

Related Links

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http://www.rirl.org/

RIRL company webpage

Other Identifiers

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009/12

Identifier Type: -

Identifier Source: org_study_id

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