AsthmaeNOughNCT00388570
Study of Monitoring Exhaled NO in Symptomatic Asthmatic Adults and Children During Anti-inflammatory Treatment
A study testing The Aerocrine NIOX MINO® Airway Inflammation Monitor in people with Asthma, run by Aerocrine AB at 2 sites in 2 countries.
Trial summary
The purpose of this study is to demonstrate substantial equivalence between two medical devices which measure nitric oxide in exhaled breath, NIOX MINO® and NIOX® in Symptomatic Asthmatic Adults and Children. Read more about this study
- Who is it for?
- Ages 4 to 65 years
- Conditions the study is for
- Asthma
- What is being tested?
- The Aerocrine NIOX MINO® Airway Inflammation Monitor
- Type of treatment
- Medical device
- How many people
- 151 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Oct 2006to Jul 2007
- Phase
- Interventional
- 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 4 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Children, and adults.
- A history of physician-diagnosed asthma or asthma diagnosed by a physician.
- Spirometry performed parameters.
- An increased FENO value.
- Symptomatic asthma as defined on the Asthma Control Questionnaire® (ACQ).
Who cannot join
- Use of oral corticosteroids.
- Use of intranasal corticosteroids.
- Use of non-steroidal anti-asthma drugs.
- Current serious conditions and/or therapies that are confounding factors.
- Pregnancy.
- Other significant respiratory diseases and/or cardiovascular diseases.
Show all 14Show fewer
- Current participation in another interventional clinical study.
- Inability to comply with the study procedures, e.g. spirometry and FENO measurements according to standard procedures.
- Unwillingness to sign informed consent and comply with treatment and visits.
- Smoking within 6 months before the study, or a smoking history of >10 pack years or an equivalent amount of other tobacco use.
- Known alcohol or drug abuser.
- Food and beverage (other than water) intake within 1 hour before first FENO measurement
- Nicotine (including nicotine chewing gum, nicotine patch, snuff etc) use within 1 hour before first FENO measurement.
- Strenuous exercise within 1 hour before first FENO measurement
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Sweden1 site
Näsets Läkargrupp, Falsterbov. 79, SE-23651 Höllviken
Höllviken, SE-23651
United Kingdom1 site
Department of General Practice & Primary Care University of Aberdeen
Aberdeen, AB252AY
About this study
Official title: A Multicenter, Device Randomized, Open-label Prospective Single-cohort Study of Monitoring Exhaled NO in Symptomatic Asthmatic Adults and Children During Anti-inflammatory Treatment
The purpose of this study is to demonstrate substantial equivalence between two medical devices which measure nitric oxide in exhaled breath, NIOX MINO® and NIOX® in Symptomatic Asthmatic Adults and Children.
Read the detailed description
Asthma is a chronic inflammatory disorder of the airways. Chronically inflamed airways are hyperresponsive; they become obstructed and airflow is limited (by bronchoconstriction, mucus plugs, and increased inflammation) when airways are exposed to various risk factors. Asthma causes recurring episodes of wheezing, breathlessness, chest tightness, and coughing particularly at night or in the early morning.
NO is an important endogenous regulatory molecule that is widely distributed throughout the body. The detection of NO in exhaled air was first reported in 1991, and, soon after it was shown that the levels NO in exhaled air are elevated in patients with asthma. There is now much evidence showing that measurement of the concentration of NO in exhaled air offers a useful non-invasive method of assessing inflammatory airway disease.
Exhaled NO is not increased during bronchospasm unless there is coexisting inflammation. Exhaled NO may have a valuable role in differentiating between the inflammatory and bronchospastic components of clinical asthma, and is also useful for guiding the therapeutic use of steroids and other anti-inflammatory agents.
A study on asthmatics and non-asthmatics subjects has shown that substantial equivalence exists between the stationary device NIOX® and the hand held device NIOX MINO® when comparing NO measurements, when similar conditions are considered and examinations are made as consistently as possible.
In a study with the stationary device NIOX®, exhaled NO was measured before and after two weeks of inhaled corticosteroid treatment in unstable steroid-naïve adult and paediatric asthmatic subjects. The result was a 50.5% mean reduction of exhaled NO. The change in exhaled NO was also compared to change in standard asthma outcome measures, asthma symptoms and spirometry.
- Conditions
- Asthma
- Being tested
- The Aerocrine NIOX MINO® Airway Inflammation Monitor
- Keywords
- Asthma, adult, paediatric, NIOX MINO®, NIOX®, nitric oxide, airway inflammation, open-label, single-cohort
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Aerocrine NIOX MINO® Airway Inflammation MonitorDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary analysis variable will be the percent change in FENO measured with
NIOX MINO® and NIOX® between Visit 1 to Visit 2.
Secondary outcomes (7)
Agreement between NIOX MINO® and NIOX® will be assessed by comparing
individual pair-wise FENO measurements from visit V1.
The change in FENO measured with NIOX MINO following corticosteroid therapy
in asthma will be compared with improvements in standard asthma outcome
measures (asthma symptoms and spirometry).
To investigate the inter-operator variability FENO measurements with
NIOX MINO in the same subject when different operators take FENO measurements. Three operator each takes two completed measurements in the same subject in a point of care setting.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2006 (estimated)
- Study startOct 2006
- Primary completionJun 2007
- Study completionJul 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 151 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aerocrine AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- David Price, Professor, Study chair, Dept of General Practice and Primary Care, University of AberdeenSven-Erik Dahlén, Professor, Study chair, Unit for Experimental Asthma and Allergy Research Division of Physiology, The National Institute of Environmental Medicine Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00388570
- Sponsor's protocol ID
- AER-036
- Acronym
- eNOugh
- Status last verified
- Nov 2011
- First submitted
- 16 Oct 2006
- Last updated
- 4 Nov 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Device Randomized, Open-label Prospective Single-cohort Study of Monitoring Exhaled NO in Symptomatic Asthmatic Adults and Children During Anti-inflammatory Treatment
- ClinicalTrials.gov ID
- NCT00388570
- Acronym / sponsor ID
- eNOugh / AER-036
- Conditions
- Asthma
- Keywords
- Asthma, adult, paediatric, NIOX MINO®, NIOX®, nitric oxide, airway inflammation, open-label
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 151 participants (actual)
- Lead sponsor
- Aerocrine ABIndustry (pharma, biotech, devices)
- Study start
- Oct 2006
- Primary completion
- Jun 2007 (actual)
- Study completion
- Jul 2007 (actual)
- First posted
- 17 Oct 2006 (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.
The purpose of this study is to demonstrate substantial equivalence between two medical devices which measure nitric oxide in exhaled breath, NIOX MINO® and NIOX® in Symptomatic Asthmatic Adults and Children.
Detailed description
Asthma is a chronic inflammatory disorder of the airways. Chronically inflamed airways are hyperresponsive; they become obstructed and airflow is limited (by bronchoconstriction, mucus plugs, and increased inflammation) when airways are exposed to various risk factors. Asthma causes recurring episodes of wheezing, breathlessness, chest tightness, and coughing particularly at night or in the early morning.
NO is an important endogenous regulatory molecule that is widely distributed throughout the body. The detection of NO in exhaled air was first reported in 1991, and, soon after it was shown that the levels NO in exhaled air are elevated in patients with asthma. There is now much evidence showing that measurement of the concentration of NO in exhaled air offers a useful non-invasive method of assessing inflammatory airway disease.
Exhaled NO is not increased during bronchospasm unless there is coexisting inflammation. Exhaled NO may have a valuable role in differentiating between the inflammatory and bronchospastic components of clinical asthma, and is also useful for guiding the therapeutic use of steroids and other anti-inflammatory agents.
A study on asthmatics and non-asthmatics subjects has shown that substantial equivalence exists between the stationary device NIOX® and the hand held device NIOX MINO® when comparing NO measurements, when similar conditions are considered and examinations are made as consistently as possible.
In a study with the stationary device NIOX®, exhaled NO was measured before and after two weeks of inhaled corticosteroid treatment in unstable steroid-naïve adult and paediatric asthmatic subjects. The result was a 50.5% mean reduction of exhaled NO. The change in exhaled NO was also compared to change in standard asthma outcome measures, asthma symptoms and spirometry.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
Who may qualify
- Ages
- 4 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Children, and adults.
- A history of physician-diagnosed asthma or asthma diagnosed by a physician.
- Spirometry performed parameters.
- An increased FENO value.
- Symptomatic asthma as defined on the Asthma Control Questionnaire® (ACQ).
Key exclusion criteria (14 listed)
- Use of oral corticosteroids.
- Use of intranasal corticosteroids.
- Use of non-steroidal anti-asthma drugs.
- Current serious conditions and/or therapies that are confounding factors.
- Pregnancy.
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 |
|---|---|---|
| The Aerocrine NIOX MINO® Airway Inflammation Monitor | Device | – |
Primary outcome
The primary analysis variable will be the percent change in FENO measured with
NIOX MINO® and NIOX® between Visit 1 to Visit 2.
7 secondary outcomes
Agreement between NIOX MINO® and NIOX® will be assessed by comparing
individual pair-wise FENO measurements from visit V1.
The change in FENO measured with NIOX MINO following corticosteroid therapy
in asthma will be compared with improvements in standard asthma outcome
measures (asthma symptoms and spirometry).
To investigate the inter-operator variability FENO measurements with
NIOX MINO in the same subject when different operators take FENO measurements. Three operator each takes two completed measurements in the same subject in a point of care setting.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2011.
Related trials for Asthma
RecruitingPhase 1
Pilot Study to Identify the Mediators and Inflammatory Cell Surface Receptors Involved in Allergic Airway Inflammation
Asthma
RecruitingPhase 1
A Study to Compare the Relative Potency of Salbutamol Administered Via Metered Dose Inhalers (MDI) Containing Propellants HFA-152a to HFA-134a in Mild Asthmatics Aged 18 to 65 Inclusive
Asthma, Mild Asthma
RecruitingPhase 3
A Study Assessing the Effect of Dupilumab on Inducing Clinical Remission in Asthma
Asthma Control
Active, not recruitingPhase 2/3
Local Antibiotic Delivery for Community Acquired Pneumonia
Community Acquired Pneumonia (CAP)
RecruitingPhase 2
A Study to Learn About the Study Medicine Called PF-07275315 in People With Moderate-To-Severe Asthma
Asthma
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.
David Price, Professor study chair
Dept of General Practice and Primary Care, University of Aberdeen
Sven-Erik Dahlén, Professor study chair
Unit for Experimental Asthma and Allergy Research Division of Physiology, The National Institute of Environmental Medicine Karolinska Institutet
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The Aerocrine NIOX MINO® Airway Inflammation Monitor in people with Asthma, run by Aerocrine AB at 2 sites in 2 countries.
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 5 inclusion and 14 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: finished, as of the sponsor's last update on 4 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Sweden, 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The primary analysis variable will be the percent change in FENO measured with. 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?
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 4 Nov 2011; AzTrials last refreshed its copy on 8 Nov 2026.