AsthmaNCT02140684
Exhaled Nitric Oxide in Asthma Management
An observational study of Asthma, run by Research in Real-Life Ltd at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 6 to 80 years
- Conditions the study is for
- Asthma
- What is being tested?
- eNO monitoring
- Type of treatment
- Medical device
- How many people
- 400 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Mar 2012to Jan 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Asthma patients who either: * Use eNO monitoring in their asthma management * Do not use eNO monitoring
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Asthma
- Being tested
- eNO monitoring
- Keywords
- Real-world, observational, Nitric oxide, Inhaled corticosteroid, UK
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
eNO monitoringDevice
Patient undergoing review with eNO monitored using either NIOX MINO® and NIOX Flex®
| Study group | Role | What they receive |
|---|---|---|
| eNO monitoring | Patients undergoing eNO monitoring at the index prescription date Receives: Device: eNO monitoring | |
| No eNO monitoring | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: One Year Outcome Period
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.
Measured: One year outcome period
Secondary outcomes (2)
Asthma Control (including SABA)
Proxy asthma control (defined above), including the absence of average daily prescribed dose of ≤200mcg salubtamol / ≤500mcg terbutaline
Measured: One year outcome
Respiratory-related hospitalisations and referrals
Mean number of respiratory-related hospitalisations and referrals per patient during the outcome year
Measured: One year outcome period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2014 (estimated)
- Study startMar 2012
- Primary completionJan 2015 (estimated)
- Study completionJan 2015 (estimated)
Why it stopped: suspended due to lack of data.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Research in Real-Life Ltd
- Sponsor type
- Research network
- Collaborators
- Aerocrine AB
- Responsible party
- Principal investigator, David Price, Prof., MD, Research in Real-Life Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02140684
- Sponsor's protocol ID
- 009/12
- Status last verified
- May 2014
- First submitted
- 14 May 2014
- Last updated
- 16 May 2014
- Results posted
- No
Publications
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.
PubMed 9663469Baraldi 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.
PubMed 9872848Piacentini 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.
PubMed 10589019Bukstein 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.
PubMed 21477457
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02140684
- Acronym / sponsor ID
- 009/12
- Conditions
- Asthma
- Keywords
- Real-world, observational, Nitric oxide, Inhaled corticosteroid, UK
- Study type
- Observational
- Recruitment status
- SuspendedReason stopped: suspended due to lack of data.
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Research in Real-Life LtdResearch network
- Collaborators
- Aerocrine AB
- Study start
- Mar 2012
- Primary completion
- Jan 2015 (estimated)
- Study completion
- Jan 2015 (estimated)
- First posted
- 16 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| eNO monitoring | – | Device: eNO monitoringPatients undergoing eNO monitoring at the index prescription date |
| No eNO monitoring | – | – |
Who may qualify
- Ages
- 6 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Asthma patients who either: * Use eNO monitoring in their asthma management * Do not use eNO monitoring
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| eNO monitoringPatient undergoing review with eNO monitored using either NIOX MINO® and NIOX Flex® | Device | eNO monitoring |
Primary outcome
Severe Exacerbation Rate
Time frame: 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
Proxy Asthma Control
Time frame: 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.
2 secondary outcomes
Asthma Control (including SABA)
Time frame: One year outcome
Respiratory-related hospitalisations and referrals
Time frame: One year outcome period
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2014.
- Background: PubMed 9663469Clancy 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.
- Background: PubMed 9872848Baraldi 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.
- Background: PubMed 10589019Piacentini 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.
- Background: PubMed 21477457Bukstein 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.
- RIRL company webpageLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma, run by Research in Real-Life Ltd at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 16 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Severe Exacerbation Rate (time frame: One Year Outcome Period). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02140684, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2014.