AsthmaNCT00819676
Analysis of Exhaled Breath by Biosensors in Adults With Asthma
An observational study of Asthma, run by Catholic University of the Sacred Heart at 1 site in Italy.
Trial summary
The aim of this study is to investigate the pattern of organic volatile compounds (VOCs) in the exhaled breath detected by biosensors in adults with persistent mild asthma. The analysis of VOCs detected by biosensors in asthmatic adults will be compared with that in a control group of healthy subjects and with exhaled… Read more about this study
- Who is it for?
- Ages 15 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthma
- What is being tested?
- analysis of exhaled breath by biosensors and measurement of exhaled nitric oxide
- How many people
- 47 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2009to Jul 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 15 to 70 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: asthma clinic, community sample
Who may be able to join
- Patient is male or female, at least 15 years of age and no more than 70 years.
- Patient has mild persistent asthma (step 2) of the Guidelines for the Diagnosis and Management of Asthma issued by the National Heart, Lung, and Blood Institute of the National Institutes of Health as defined by a history of symptoms at least once a week but less than daily (step 2) (5).
- Current asthma treatment includes short-acting inhaled β-agonist alone as needed.
- Patient fulfils all the following signs and symptoms of asthma:
- History of symptoms including, but not limited to dyspnea, wheezing, chest tightness, cough, or sputum production for at least 12 months.
- A forced expiratory volume in one second (FEV1) of at least 80% of the predicted value (pre-bronchodilator) while withholding β-agonist for at least six hours.
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- Patient has a diagnosis of asthma as defined by 1) an increase in FEV1 or PEF of ≥12% (absolute value), 20 to 30 minutes after inhaled β-agonist administration, OR 2) a positive methacholine PC20 (provocative concentration causing a 20% fall in FEV1) of 8 mg/ml or lower which was performed within the previous 12 months, OR 3) a fall in FEV1 of at least 15% after an exercise challenge which was performed within the previous 12 months. β-agonist reversibility and the methacholine and exercise challenge tests may be satisfied within the previous 12 months if there is adequate source documentation.
- Patients demonstrate symptoms requiring β-agonist use on ≥2 and ≤6 days of the week for the previous two weeks.
- Patient is able to chew a tablet.
- Patient is judged to be in good, stable physical and mental health (except for his/her asthma) based on the medical history, physical examination, and routine laboratory data, and appears able to successfully complete this trial.
- Ability to perform reproducible spirometry.
- Nonsmoker including no use of smokeless tobacco products in the past year.
- Ability of parent to provide informed consent, as evidenced by signing a copy of the consent form approved by the institutional review board of the subject's respective study institution
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Analysis of Exhaled Breath by Biosensors in Adults With Asthma: Observational Part of the Study "Effects of add-on Therapy With Oral Montelukast on the Analysis of Exhale Breath by Biosensors in Adults With Asthma
The aim of this study is to investigate the pattern of organic volatile compounds (VOCs) in the exhaled breath detected by biosensors in adults with persistent mild asthma. The analysis of VOCs detected by biosensors in asthmatic adults will be compared with that in a control group of healthy subjects and with exhaled nitric oxide (NO).
Identification of breath VOC patterns may be a completely noninvasive new technique for assessing airway inflammation. A device containing a series of nanosensors can be used for breath analysis of VOC patterns through integration with a suitable algorithm for pattern recognition.
Read more
Preliminary data indicate that exhaled breath patterns detected by biosensors in healthy subjects are different from those in patients with asthma. In patients with asthma, analysis of exhaled breath using biosensors will be compared with exhaled NO measurement for studying a possible correlation with an independent method for assessing airway inflammation and with spirometry for assessing a possible correlation with lung function.
Measurement of exhaled NO is a well-established, validated, and standardized method for assessing and monitoring of airway inflammation in patients with asthma who are steroid-naive. In patients with asthma, exhaled NO concentrations are correlated with blood eosinophil cell counts and with airway hyperresponsiveness (AHR).
This study could contribute to the identification and development of a completely new non-invasive technique for assessing airway inflammation with important implications for diagnosis and therapeutic monitoring of patients with asthma.
Establishing the effect of anti-inflammatory drugs on breath analysis by biosensors in patients with asthma is relevant for future studies aimed to use this technique in asthma management.
- Conditions
- Asthma
- Being tested
- analysis of exhaled breath by biosensors, measurement of exhaled nitric oxide
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
analysis of exhaled breath by biosensorsOther
measurement of exhaled nitric oxideOther
| Study group | Role | What they receive |
|---|---|---|
| subjects with asthma | Not described Receives: Other: analysis of exhaled breath by biosensors; Other: measurement of exhaled nitric oxide | |
| healthy subjects | Not described Receives: Other: analysis of exhaled breath by biosensors; Other: measurement of exhaled nitric oxide |
What is being measured
The primary outcome is the main question the study is designed to answer.
exhaled nitric oxide
Measured: baseline
Secondary outcomes (6)
analysis of breath by biosensors
Measured: baseline
FEV1
Measured: baseline
FVC
Measured: baseline
FEV1/FVC ratio
Measured: baseline
FEF25%-75%
Measured: baseline
PEF
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2009 (estimated)
- Study startJan 2009
- Primary completionJul 2009
- Study completionJul 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.
- 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-control
- Time perspective
- Cross-sectional
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Catholic University of the Sacred Heart
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Investigators
- Paolo Montuschi, M.D., Principal investigator, Catholic University of the Sacred Heart
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00819676
- Sponsor's protocol ID
- A/220/2007
- Status last verified
- Jul 2009
- First submitted
- 8 Jan 2009
- Last updated
- 3 Aug 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Montuschi P, Santonico M, Mondino C, Pennazza G, Mantini G, Martinelli E, Capuano R, Ciabattoni G, Paolesse R, Di Natale C, Barnes PJ, D'Amico A. Diagnostic performance of an electronic nose, fractional exhaled nitric oxide, and lung function testing in asthma. Chest. 2010 Apr;137(4):790-6. doi: 10.1378/chest.09-1836. Epub 2010 Jan 15.
PubMed 20081096
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Exhaled Breath by Biosensors in Adults With Asthma: Observational Part of the Study "Effects of add-on Therapy With Oral Montelukast on the Analysis of Exhale Breath by Biosensors in Adults With Asthma
- ClinicalTrials.gov ID
- NCT00819676
- Acronym / sponsor ID
- A/220/2007
- Conditions
- Asthma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Catholic University of the Sacred HeartUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- Jan 2009
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 9 Jan 2009 (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 aim of this study is to investigate the pattern of organic volatile compounds (VOCs) in the exhaled breath detected by biosensors in adults with persistent mild asthma. The analysis of VOCs detected by biosensors in asthmatic adults will be compared with that in a control group of healthy subjects and with exhaled nitric oxide (NO).
Identification of breath VOC patterns may be a completely noninvasive new technique for assessing airway inflammation. A device containing a series of nanosensors can be used for breath analysis of VOC patterns through integration with a suitable algorithm for pattern recognition.
Preliminary data indicate that exhaled breath patterns detected by biosensors in healthy subjects are different from those in patients with asthma. In patients with asthma, analysis of exhaled breath using biosensors will be compared with exhaled NO measurement for studying a possible correlation with an independent method for assessing airway inflammation and with spirometry for assessing a possible correlation with lung function.
Measurement of exhaled NO is a well-established, validated, and standardized method for assessing and monitoring of airway inflammation in patients with asthma who are steroid-naive. In patients with asthma, exhaled NO concentrations are correlated with blood eosinophil cell counts and with airway hyperresponsiveness (AHR).
This study could contribute to the identification and development of a completely new non-invasive technique for assessing airway inflammation with important implications for diagnosis and therapeutic monitoring of patients with asthma.
Establishing the effect of anti-inflammatory drugs on breath analysis by biosensors in patients with asthma is relevant for future studies aimed to use this technique in asthma management.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| subjects with asthma | – | Other: analysis of exhaled breath by biosensors, Other: measurement of exhaled nitric oxide |
| healthy subjects | – | Other: analysis of exhaled breath by biosensors, Other: measurement of exhaled nitric oxide |
Who may qualify
- Ages
- 15 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- asthma clinic, community sample
Key inclusion criteria (13 listed)
- Patient is male or female, at least 15 years of age and no more than 70 years.
- Patient has mild persistent asthma (step 2) of the Guidelines for the Diagnosis and Management of Asthma issued by the National Heart, Lung, and Blood Institute of the National Institutes of Health as defined by a history of symptoms at least once a week but less than daily (step 2) (5).
- Current asthma treatment includes short-acting inhaled β-agonist alone as needed.
- Patient fulfils all the following signs and symptoms of asthma:
- Patient is able to chew a tablet.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| analysis of exhaled breath by biosensors | Other | healthy subjects, subjects with asthma |
| measurement of exhaled nitric oxide | Other | healthy subjects, subjects with asthma |
Primary outcome
exhaled nitric oxide
Time frame: baseline
6 secondary outcomes
analysis of breath by biosensors
Time frame: baseline
FEV1
Time frame: baseline
FVC
Time frame: baseline
FEV1/FVC ratio
Time frame: baseline
FEF25%-75%
Time frame: baseline
PEF
Time frame: baseline
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 Aug 2009.
- Derived from this study: PubMed 20081096Montuschi P, Santonico M, Mondino C, Pennazza G, Mantini G, Martinelli E, Capuano R, Ciabattoni G, Paolesse R, Di Natale C, Barnes PJ, D'Amico A. Diagnostic performance of an electronic nose, fractional exhaled nitric oxide, and lung function testing in asthma. Chest. 2010 Apr;137(4):790-6. doi: 10.1378/chest.09-1836. Epub 2010 Jan 15.
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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.
Paolo Montuschi, M.D. principal investigator
Catholic University of the Sacred Heart
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 Catholic University of the Sacred Heart 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 13 inclusion and 0 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 Aug 2009. 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.
What does the primary outcome measure?
exhaled nitric oxide (time frame: baseline). 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 NCT00819676, 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 3 Aug 2009.