AsthmaNCT05149885
A Feasibility Study of SenseGuard to Assess Airway Responsiveness During Methacholine Challenge Test (MCT)
A study testing SenseGuard monitoring in people with Asthma, run by NanoVation at 1 site in Cyprus.
Trial summary
SenseGuard (SG) is an innovative device for respiratory monitoring. At this study SG measurement will be integrated in a Methacholine Challenge Test (MCT) for monitoring changes in airway obstruction occurred during MCT in parallel to spirometry. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Asthma
- What is being tested?
- SenseGuard monitoring
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteCyprus
- Study dates
- 4 Nov 2021to 1 Jun 2023
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, aged ≥18.
- Eligible for MCT procedure. The contradictions to MCT are listed as exclusion criteria.
- Provision of a signed and dated informed consent form.
- Subject who receives one of the following medications, that decrease bronchial hyperresponsiveness, is required for a washout period, before conducting the MCT: inhaled bronchodilators, oral albuterol , inhaled and oral glucocorticoids, leukotriene modifying agents, theophylline, cromolyn, and anti-histamines due to their anticholinergic effect.
Who cannot join
- Subjects who have known contradictions to MCT, including:
- Tolerate inhalation of the challenge agents
- Low baseline FEV1: Airflow limitations in FEV1 less than 60% predicted or 1.5L (baseline FEV1 of < 1.5 L or < 60% predicted).
- Spirometry quality: inability to consistently reproduce quality spirometry
- Cardiovascular problems: recent myocardial infarction within past three months, uncontrolled hypertension, known aortic aneurysm
- Recent ophthalmologic surgery or patients at risk for intracranial pressure elevation.
Show all 9Show fewer
- Pregnancy and nursing mothers: Methacholine is a pregnancy category C drug and it is not known whether it is excreted in breast milk or is associated with fetal abnormalities. Women subjects will be asked to sign a statement, as part of the Informe Consent Form, that they are not pregnant or nursing mothers).
- Inability to provide informed consent.
- Known allergic reactions to materials used in the components of the SG, i.e., polyethylene or silicon, or gold, nickel, copper or alloys containing any of the above.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Feasibility Study of a Non-Invasive Wearable Device in Assessing Airway Responsiveness Related Parameters During Methacholine Challenge Test (MCT)
SenseGuard (SG) is an innovative device for respiratory monitoring. At this study SG measurement will be integrated in a Methacholine Challenge Test (MCT) for monitoring changes in airway obstruction occurred during MCT in parallel to spirometry.
Read the detailed description
SenseGuard (SG) is a wireless wearable medical device intended for monitoring of patient's breathing. It allows to seamlessly monitor patient's tidal breathing, at rest or during daily activities, and to extract critical respiratory parameters, such as respiration rate (RR) and durations, ratios and variability of phases within the breath-cycle, including: inspired breath (Ti) and expired breath (Te).
The study goal is to evaluate the capability of SG to measure clinical changes in respiratory parameters.
During Methacholine Challenge Test (MCT), asthma patients demonstrate airway responsiveness due to airway obstruction. SG will be used to measure respiratory parameters during MCT in parallel to spirometry and the correlation between measurable respiratory parameters will be assessed.
Successful study results will demonstrate the capability of SG to measure changes in airway obstruction leading to future implementation of SG for monitoring of patients with respiratory diseases and improvement of their clinical outcome.
- Conditions
- Asthma
- Being tested
- SenseGuard monitoring
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SenseGuard monitoringDevice
All subjects that recruited to the study will undergo MCT as usual with the addition of SG measurement after each Methacholine dose and spirometry test.
| Study group | Role | What they receive |
|---|---|---|
| Investigational SenseGuard Device | Experimental | Subjects with suspected diagnosis of Asthma and eligible for MCT will be recruited to the study.
The MCT procedure will be performed as usual, with the addition of SG measurements after each spirometry for each Methacholine dose. Receives: Device: SenseGuard monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Respiratory parameters (Inhalation and Exhalation time and ratio) measured by SG during MCT can indicate for changes in airway obstruction occurred in positive MCT
SG respiratory parameters(Inhalation and Exhalation (I/E) time and ratio), can measure successfully changes in respiratory parameters during MCT procedure, in at least of 70% of the subjects with MCT positive result (FEV1 < 20% of predicted FEV1).
Measured: 6 months
Secondary outcomes (1)
SG respiratory parameters (Inhalation and Exhalation time and ratio) are in correlation with Spirometry values (FEV1) obtained during MCT
There is at least 70% correlation between changes in respiratory parameters measured by SG (Inhalation and Exhalation (I/E) time and ratio),and by Spirometry values (%FEV1 reduced from baseline) for at least 70% of subjects participating in the study.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2021
- Study start4 Nov 2021
- Primary completion25 Mar 2023
- Study completion1 Jun 2023
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- NanoVation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05149885
- Sponsor's protocol ID
- PD-CLN-001
- Status last verified
- Mar 2024
- First submitted
- 3 Nov 2021
- Last updated
- 26 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Study of a Non-Invasive Wearable Device in Assessing Airway Responsiveness Related Parameters During Methacholine Challenge Test (MCT)
- ClinicalTrials.gov ID
- NCT05149885
- Acronym / sponsor ID
- PD-CLN-001
- Conditions
- Asthma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- NanoVationIndustry (pharma, biotech, devices)
- Study start
- 4 Nov 2021 (actual)
- Primary completion
- 25 Mar 2023 (actual)
- Study completion
- 1 Jun 2023 (actual)
- First posted
- 8 Dec 2021 (actual)
- 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.
SenseGuard (SG) is an innovative device for respiratory monitoring. At this study SG measurement will be integrated in a Methacholine Challenge Test (MCT) for monitoring changes in airway obstruction occurred during MCT in parallel to spirometry.
Detailed description
SenseGuard (SG) is a wireless wearable medical device intended for monitoring of patient's breathing. It allows to seamlessly monitor patient's tidal breathing, at rest or during daily activities, and to extract critical respiratory parameters, such as respiration rate (RR) and durations, ratios and variability of phases within the breath-cycle, including: inspired breath (Ti) and expired breath (Te).
The study goal is to evaluate the capability of SG to measure clinical changes in respiratory parameters.
During Methacholine Challenge Test (MCT), asthma patients demonstrate airway responsiveness due to airway obstruction. SG will be used to measure respiratory parameters during MCT in parallel to spirometry and the correlation between measurable respiratory parameters will be assessed.
Successful study results will demonstrate the capability of SG to measure changes in airway obstruction leading to future implementation of SG for monitoring of patients with respiratory diseases and improvement of their clinical outcome.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Investigational SenseGuard Device | Experimental | Device: SenseGuard monitoringSubjects with suspected diagnosis of Asthma and eligible for MCT will be recruited to the study. The MCT procedure will be performed as usual, with the addition of SG measurements after each spirometry for each Methacholine dose. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female, aged ≥18.
- Eligible for MCT procedure. The contradictions to MCT are listed as exclusion criteria.
- Provision of a signed and dated informed consent form.
- Subject who receives one of the following medications, that decrease bronchial hyperresponsiveness, is required for a washout period, before conducting the MCT: inhaled bronchodilators, oral albuterol , inhaled and oral glucocorticoids, leukotriene modifying agents, theophylline, cromolyn, and anti-histamines due to their anticholinergic effect.
Key exclusion criteria (9 listed)
- Subjects who have known contradictions to MCT, including:
- Inability to provide informed consent.
- Known allergic reactions to materials used in the components of the SG, i.e., polyethylene or silicon, or gold, nickel, copper or alloys containing any of the above.
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 |
|---|---|---|
| SenseGuard monitoringAll subjects that recruited to the study will undergo MCT as usual with the addition of SG measurement after each Methacholine dose and spirometry test. | Device | Investigational SenseGuard Device |
Primary outcome
Respiratory parameters (Inhalation and Exhalation time and ratio) measured by SG during MCT can indicate for changes in airway obstruction occurred in positive MCT
Time frame: 6 months
SG respiratory parameters(Inhalation and Exhalation (I/E) time and ratio), can measure successfully changes in respiratory parameters during MCT procedure, in at least of 70% of the subjects with MCT positive result (FEV1 < 20% of predicted FEV1).
1 secondary outcome
SG respiratory parameters (Inhalation and Exhalation time and ratio) are in correlation with Spirometry values (FEV1) obtained during MCT
Time frame: 6 months
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 26 Mar 2024.
- Individual participant dataSharing planned: Yes
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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.
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?
A study testing SenseGuard monitoring in people with Asthma, run by NanoVation at 1 site in Cyprus.
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 4 inclusion and 9 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 26 Mar 2024. 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 Cyprus. 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?
Respiratory parameters (Inhalation and Exhalation time and ratio) measured by SG during MCT can indicate for changes in airway obstruction occurred in positive MCT (time frame: 6 months). 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 26 Mar 2024.