AsthmaNOASTHMANCT00562991
Monitoring Asthma Treatment Using Exhaled Nitric Oxide
An observational study of Asthma, run by University Hospital, Antwerp at 7 sites in Belgium.
Trial summary
Asthma is a chronic inflammatory condition in which the airways develop increased responsiveness to various stimuli such as exposure to an allergen, cold air or exercise. It is characterized by airway hyper-responsiveness, inflammation, increased mucus production, and airway obstruction. Read more about this study
- Who is it for?
- Ages 5 to 14 years
- Conditions the study is for
- Asthma
- What is being tested?
- measurement of exhaled NO is used to guide treatment
- Type of treatment
- Medical device
- How many people
- 99 participants
- Where
- 7 sitesBelgium
- Study dates
- 1 Oct 2007to Dec 2009
- 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 5 to 14 years
- All sexes
- No healthy volunteers
- Child
Study population: asthmatic children
Who may be able to join
- Male or female children, aged 6-14 years
- A documented history of asthma for a period of at least 6 months
- Mild to severe persistent asthma according to GINA guidelines
- A documented history of allergic sensitization (positive skin prick test or specific IgE
- Subject's guardian/parent should be able to complete a symptom score on behalf of the subject.
- Subject's guardian/parent should be able to send a symptom score weekly by sms
- Both parents have to give written informed consent to participate in the study
Who cannot join
- Received any investigational study medication in the 4 weeks prior to screening Visit
- Significant comorbidity such as concurrent infection, history of prematurity, history of bronchopulmonary dysplasia, cystic fibrosis, other chronic lung diseases, and other severe chronic diseases
- Acute asthma exacerbation within 4 weeks of screening visit
- Hospitalization within 12 weeks of screening visit
- Systemic corticosteroids within 12 weeks of screening visit
- Oral corticosteroid dependence
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Belgium7 sites
University Hospital Antwerp
Antwerp, 2650
Algemeen Ziekenhuis St Jan
Bruges, 8000
Univ des enfants Reine Fabiola
Brussels, 1020
Hôpital Erasme
Brussels
Virga Jesseziekenhuis
Hasselt, 3500
Algemeen ziekenhuis Turnhout, Campus Sint-Jozef
Turnhout
CH Peltzer
Verviers, 4800
About this study
Asthma is a chronic inflammatory condition in which the airways develop increased responsiveness to various stimuli such as exposure to an allergen, cold air or exercise. It is characterized by airway hyper-responsiveness, inflammation, increased mucus production, and airway obstruction. Since inflammation is an important feature of asthma, the use of non-invasive tests to measure lung inflammation to monitor asthma are of interest.The purpose of the study is to relate costs associated with healthcare utilization and loss of work and school time to the primary health outcome of cumulative number of symptom-free days. This will enable the researchers to determine whether the costs of monitoring exhaled NO to regular management strategy in recently diagnosed asthma will be offset by reductions in other costs of asthma-related care, and, if not, whether the additional costs are likely to be acceptable in terms of the improvement in health outcomes as measured by the additional number of symptom-free days.
- Conditions
- Asthma
- Being tested
- measurement of exhaled NO is used to guide treatment
- Keywords
- exhaled NO, asthma, child
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
measurement of exhaled NO is used to guide treatmentDevice
exhaled NO
| Study group | Role | What they receive |
|---|---|---|
| FeNO group | asthma patients, exhaled NO is used to monitor asthma Receives: Device: measurement of exhaled NO is used to guide treatment | |
| Symptom group | asthma patients, exhaled NO is not used to monitor asthma |
What is being measured
The primary outcome is the main question the study is designed to answer.
symptom-free days
Measured: 1 year time frame with visits every 3 months
Secondary outcomes (1)
days spent in hospital,emergency room visits,physician or nurse contacts use of drugs, days on which school was missed, number of exacerbations
Measured: 1 year time frame
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2007 (estimated)
- Study start1 Oct 2007
- Primary completion1 Oct 2008
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by University Hospital, AntwerpThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Antwerp
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC, Aerocrine AB
- Responsible party
- Sponsor
- Investigators
- kristine N Desager, PhD, Principal investigator, University Hospital, Antwerp
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00562991
- Sponsor's protocol ID
- B30020072436
- Acronym
- NOASTHMA
- Status last verified
- Nov 2007
- First submitted
- 21 Nov 2007
- Last updated
- 28 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Peirsman EJ, Carvelli TJ, Hage PY, Hanssens LS, Pattyn L, Raes MM, Sauer KA, Vermeulen F, Desager KN. Exhaled nitric oxide in childhood allergic asthma management: a randomised controlled trial. Pediatr Pulmonol. 2014 Jul;49(7):624-31. doi: 10.1002/ppul.22873. Epub 2013 Sep 4.
PubMed 24039119
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monitoring Asthma Treatment Using Exhaled Nitric Oxide
- ClinicalTrials.gov ID
- NCT00562991
- Acronym / sponsor ID
- NOASTHMA / B30020072436
- Conditions
- Asthma
- Keywords
- exhaled NO, asthma, child
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- University Hospital, AntwerpUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC, Aerocrine AB
- Study start
- 1 Oct 2007 (actual)
- Primary completion
- 1 Oct 2008 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 26 Nov 2007 (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.
Asthma is a chronic inflammatory condition in which the airways develop increased responsiveness to various stimuli such as exposure to an allergen, cold air or exercise. It is characterized by airway hyper-responsiveness, inflammation, increased mucus production, and airway obstruction. Since inflammation is an important feature of asthma, the use of non-invasive tests to measure lung inflammation to monitor asthma are of interest.The purpose of the study is to relate costs associated with healthcare utilization and loss of work and school time to the primary health outcome of cumulative number of symptom-free days. This will enable the researchers to determine whether the costs of monitoring exhaled NO to regular management strategy in recently diagnosed asthma will be offset by reductions in other costs of asthma-related care, and, if not, whether the additional costs are likely to be acceptable in terms of the improvement in health outcomes as measured by the additional number of symptom-free days.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FeNO group | – | Device: measurement of exhaled NO is used to guide treatmentasthma patients, exhaled NO is used to monitor asthma |
| Symptom group | – | –asthma patients, exhaled NO is not used to monitor asthma |
Who may qualify
- Ages
- 5 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- asthmatic children
Key inclusion criteria (7 listed)
- Male or female children, aged 6-14 years
- A documented history of asthma for a period of at least 6 months
- Mild to severe persistent asthma according to GINA guidelines
- A documented history of allergic sensitization (positive skin prick test or specific IgE
- Subject's guardian/parent should be able to complete a symptom score on behalf of the subject.
Key exclusion criteria (6 listed)
- Received any investigational study medication in the 4 weeks prior to screening Visit
- Significant comorbidity such as concurrent infection, history of prematurity, history of bronchopulmonary dysplasia, cystic fibrosis, other chronic lung diseases, and other severe chronic diseases
- Acute asthma exacerbation within 4 weeks of screening visit
- Hospitalization within 12 weeks of screening visit
- Systemic corticosteroids within 12 weeks of screening visit
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 |
|---|---|---|
| measurement of exhaled NO is used to guide treatmentexhaled NO | Device | FeNO group |
Primary outcome
symptom-free days
Time frame: 1 year time frame with visits every 3 months
1 secondary outcome
days spent in hospital,emergency room visits,physician or nurse contacts use of drugs, days on which school was missed, number of exacerbations
Time frame: 1 year time frame
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 28 Jan 2021.
- Derived from this study: PubMed 24039119Peirsman EJ, Carvelli TJ, Hage PY, Hanssens LS, Pattyn L, Raes MM, Sauer KA, Vermeulen F, Desager KN. Exhaled nitric oxide in childhood allergic asthma management: a randomised controlled trial. Pediatr Pulmonol. 2014 Jul;49(7):624-31. doi: 10.1002/ppul.22873. Epub 2013 Sep 4.
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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.
kristine N Desager, PhD principal investigator
University Hospital, Antwerp
7 sites 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 University Hospital, Antwerp at 7 sites in Belgium.
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 7 inclusion and 6 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 28 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Belgium. 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?
symptom-free days (time frame: 1 year time frame with visits every 3 months). 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 NCT00562991, which also lists 1 linked publication.
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 28 Jan 2021.