AsthmaNCT01556958
WheezoMeter® Correlation Study
An observational study of Asthma and Bronchiolitis, run by iSonea at 1 site in United States.
Trial summary
The primary goal of the study is to more firmly establish correlations between WheezeRate(Wz%) and other parameters used to assess wheezing and asthma including spirometry, provider's auscultation, and symptoms at the time of Wz% measurement. Read more about this study
- Who is it for?
- Ages Up to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthma, Bronchiolitis
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2012to Mar 2013
- 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 Up to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Pediatric Specialty Clinic
Who may be able to join
- Patients <= 12 years of age who have wheezing at the time of study as confirmed by the physicians' auscultation.
- Control:
- Patients <= 12 years of age without history of asthma or other pulmonary conditions, and who are without wheezing on physical exam.
Who cannot join
- Medical problems that would contraindicate Wz% measurement.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Comparative Study of WheezeRATE™ (Wz%) Readings With Spirometry, Symptoms, and Auscultatory Findings in Children With Wheezing.
The primary goal of the study is to more firmly establish correlations between WheezeRate(Wz%) and other parameters used to assess wheezing and asthma including spirometry, provider's auscultation, and symptoms at the time of Wz% measurement.
- Conditions
- Asthma, Bronchiolitis
- Medical subject headings
- Asthma, Bronchiolitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Active Wheezing - age 5-12 | Not described | |
| Active Wheezing - under age 5 | Not described | |
| No Wheezing | Not described |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2012 (estimated)
- Study startMar 2012
- Primary completionMar 2013
- Study completionMar 2013
Why it stopped: Device revised
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-control
- Time perspective
- Prospective
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- iSonea
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01556958
- Sponsor's protocol ID
- iS-2012-Wz
- Status last verified
- Aug 2013
- First submitted
- 15 Mar 2012
- Last updated
- 19 Aug 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Comparative Study of WheezeRATE™ (Wz%) Readings With Spirometry, Symptoms, and Auscultatory Findings in Children With Wheezing.
- ClinicalTrials.gov ID
- NCT01556958
- Acronym / sponsor ID
- iS-2012-Wz
- Conditions
- Asthma, Bronchiolitis
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Device revised
- Enrolment
- 19 participants (actual)
- Lead sponsor
- iSoneaIndustry (pharma, biotech, devices)
- Study start
- Mar 2012
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 19 Mar 2012 (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 primary goal of the study is to more firmly establish correlations between WheezeRate(Wz%) and other parameters used to assess wheezing and asthma including spirometry, provider's auscultation, and symptoms at the time of Wz% measurement.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Active Wheezing - age 5-12 | – | – |
| Active Wheezing - under age 5 | – | – |
| No Wheezing | – | – |
Who may qualify
- Ages
- Up to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Pediatric Specialty Clinic
Key inclusion criteria (3 listed)
- Patients <= 12 years of age who have wheezing at the time of study as confirmed by the physicians' auscultation.
- Patients <= 12 years of age without history of asthma or other pulmonary conditions, and who are without wheezing on physical exam.
Key exclusion criteria (1 listed)
- Medical problems that would contraindicate Wz% measurement.
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 was stopped early (reason given: Device revised). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2013.
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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.
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 and Bronchiolitis, run by iSonea at 1 site in United States.
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 3 inclusion and 1 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: stopped early, as of the sponsor's last update on 19 Aug 2013. 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 States. 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 was stopped early (reason given: Device revised). 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.
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 19 Aug 2013.