A Feasibility Study of SenseGuard to Assess Airway Responsiveness During Methacholine Challenge Test (MCT)

NCT05149885 | Completed

• 1 other identifier: PD-CLN-001
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

• 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).

  6 months

Secondary Outcomes (1)

• SG respiratory parameters (Inhalation and Exhalation time and ratio) are in correlation with Spirometry values (FEV1) obtained during MCT

  6 months

Study Arms (1)

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.

Device: SenseGuard monitoring

Interventions

SenseGuard monitoring DEVICE

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.

Investigational SenseGuard Device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female, aged ≥18.

You may not qualify if:

• 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.
• 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.
• 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.

Sponsors & Collaborators

• NanoVation: lead

Study Sites (1)

Nicosia Lung Center

Nicosia, Cyprus

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2021
• First Posted: December 8, 2021
• Study Start: November 4, 2021
• Primary Completion: March 25, 2023
• Study Completion: June 1, 2023
• Last Updated: March 26, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: 6 months

Locations

CY (1)