Exhaled Nitric Oxide in Asthma Management

Asthma Clinical Trial

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT02140684
• Other study ID #: 009/12
• Status: Suspended
• Phase: N/A
• First received: May 14, 2014
• Last updated: May 14, 2014
• Start date: March 2012
• Est. completion date: January 2015

Study information

• Verified date: May 2014
• Source: Research in Real-Life Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 400
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 80 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Asthma

Intervention

Device:
• eNO monitoring
Patient undergoing review with eNO monitored using either NIOX MINO® and NIOX Flex®

Locations

Country	Name	City	State
United Kingdom	Research in Real Life	Cambridge

Sponsors (2)

Lead Sponsor	Collaborator
Research in Real-Life Ltd	Aerocrine AB

Country where clinical trial is conducted

United Kingdom, 

References & Publications (4)

Baraldi E, Carrá 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. — View 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. — View Citation

Clancy RM, Amin AR, Abramson SB. The role of nitric oxide in inflammation and immunity. Arthritis Rheum. 1998 Jul;41(7):1141-51. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	Proxy Asthma Control	No recorded hospital attendance for asthma, including admission, Emergency Room (ER) attendance or Out-Patient Department (OPD) attendance, AND; No prescriptions for acute courses of oral steroids, AND; No GP consultations, hospital admissions or ER attendance for lower respiratory tract infections (LRTI) requiring antibiotics.	One year outcome period	No
Secondary	Asthma Control (including SABA)	Proxy asthma control (defined above), including the absence of average daily prescribed dose of =200mcg salubtamol / =500mcg terbutaline	One year outcome	No
Secondary	Respiratory-related hospitalisations and referrals	Mean number of respiratory-related hospitalisations and referrals per patient during the outcome year	One year outcome period	Yes

External Links

•   RIRL company webpage