AsthmaNCT01113853
Daily Monitoring of Exhaled Nitric Oxide in Asthmatic Patients
An observational study of Asthma, run by Universita di Verona at 1 site in Italy.
Trial summary
Previous studies have demonstrated that exhaled nitric oxide can be useful to monitor the efficacy of anti-inflammatory treatment as well as to predict a risk of asthma relapse in asthmatic patients. Read more about this study
- Who is it for?
- Ages 5 years and older
- Conditions the study is for
- Asthma
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2007to Jan 2010
- 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 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: children with asthma visited in the outpatients clinic at University of Verona were invited to participate to the study
Who may be able to join
- mild asthmatic treated with low dose inhaled steroids for whom it has to be considered stop of steroid treatment according to GINA guidelines
Who cannot join
- age < 5 years
- chronic respiratory diseases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Daily Monitoring of Exhaled Nitric Oxide in Asthmatic Patients Stopping Anti-inflammatory Treatment
Previous studies have demonstrated that exhaled nitric oxide can be useful to monitor the efficacy of anti-inflammatory treatment as well as to predict a risk of asthma relapse in asthmatic patients.
The aim of the present study is to evaluate the time course of exhaled nitric oxide in mild asthmatic patients, stopping regular treatment with inhaled corticosteroids, if it is possible, in relationship with symptoms and lung function.
Read the detailed description
All patients were evaluated with pulmonary lung function, exhaled nitric oxide and peak expiratory flow (PEF) and fill in a personal diary for the first two weeks when patients are in treatment; the same evaluation will be made for other four weeks without treatment.
- Conditions
- Asthma
- Keywords
- asthma, exhaled nitric oxide, lung function
- Medical subject headings
- Asthma
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2010 (estimated)
- Study startJan 2007
- Study completionJan 2010
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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universita di Verona
- Sponsor type
- University, hospital or other
- Collaborators
- Azienda Ospedaliera Universitaria Policlinico
- Investigators
- Giorgio L Piacentini, MD, Principal investigator, Universita di Verona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01113853
- Sponsor's protocol ID
- AOV 1360
- Status last verified
- Jan 2007
- First submitted
- 28 Apr 2010
- Last updated
- 3 May 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Daily Monitoring of Exhaled Nitric Oxide in Asthmatic Patients Stopping Anti-inflammatory Treatment
- ClinicalTrials.gov ID
- NCT01113853
- Acronym / sponsor ID
- AOV 1360
- Conditions
- Asthma
- Keywords
- asthma, exhaled nitric oxide, lung function
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Universita di VeronaUniversity, hospital or other
- Collaborators
- Azienda Ospedaliera Universitaria Policlinico
- Study start
- Jan 2007
- Study completion
- Jan 2010 (actual)
- First posted
- 30 Apr 2010 (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.
Previous studies have demonstrated that exhaled nitric oxide can be useful to monitor the efficacy of anti-inflammatory treatment as well as to predict a risk of asthma relapse in asthmatic patients.
The aim of the present study is to evaluate the time course of exhaled nitric oxide in mild asthmatic patients, stopping regular treatment with inhaled corticosteroids, if it is possible, in relationship with symptoms and lung function.
Detailed description
All patients were evaluated with pulmonary lung function, exhaled nitric oxide and peak expiratory flow (PEF) and fill in a personal diary for the first two weeks when patients are in treatment; the same evaluation will be made for other four weeks without treatment.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- children with asthma visited in the outpatients clinic at University of Verona were invited to participate to the study
Key inclusion criteria (1 listed)
- mild asthmatic treated with low dose inhaled steroids for whom it has to be considered stop of steroid treatment according to GINA guidelines
Key exclusion criteria (2 listed)
- age < 5 years
- chronic respiratory diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 3 May 2010.
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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.
Giorgio L Piacentini, MD principal investigator
Universita di Verona
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 Universita di Verona at 1 site in Italy.
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 1 inclusion and 2 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 3 May 2010. 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 Italy. 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.
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 3 May 2010.