What is the mechanism of action of this treatment?

The most common treatments for Chronic Bronchitis include mucoactive agents and mechanical devices that aid in mucus clearance. Mucoactive agents, such as N-acetylcysteine and carbocysteine, work by breaking down mucus, making it less viscous and easier to expel, which helps to clear the airways and reduce cough frequency. Mechanical devices, like oscillating positive expiratory pressure (PEP) devices, create vibrations that loosen mucus from the airway walls, facilitating its removal. These treatments are crucial for Chronic Bronchitis patients as they help to manage chronic cough, improve breathing, and reduce the risk of infections and exacerbations.

What side effects are associated with this type of intervention?

Common treatments for chronic bronchitis include inhaled bronchodilators (such as beta agonists and anticholinergics), corticosteroids, and mucolytic agents. Inhaled bronchodilators can cause side effects like dry mouth, tremors, and palpitations. Corticosteroids may lead to oral thrush, hoarseness, and increased risk of infections. Mucolytic agents, such as N-acetylcysteine, can cause gastrointestinal disturbances and, rarely, allergic reactions. These treatments aim to reduce symptoms like cough and improve lung function.

What prior FDA approvals exist?

FDA-approved treatments for Chronic Bronchitis often include bronchodilators such as tiotropium and formoterol, which help to open the airways and reduce symptoms like chronic cough. Mucoactive agents, which aid in mucus clearance, are also commonly used. Fixed-dose combinations like indacaterol/glycopyrronium and umeclidinium/vilanterol have been approved for their efficacy in improving lung function and reducing exacerbations. These treatments align with the goals of the SIVA-MVP trial, which aims to measure cough frequency, a key symptom in Chronic Bronchitis management.

What other types of research exist?

Promising alternatives to SIVA-MVP for chronic bronchitis patients include: 1) Noninvasive ventilatory support devices with integrated monitoring systems, such as those used for neuromuscular diseases, which provide continuous respiratory data and support. 2) Advanced nebulizer technologies with built-in compliance tracking, like the Nebulizer Chronolog, which records and stores usage data to ensure proper medication adherence. 3) High-resolution CT imaging combined with spirometry for detailed assessment and monitoring of lung function, which can help tailor treatment plans more effectively.

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Cough Detection Device

Cough Frequency Measurement Device for Chronic Cough

N/A

Waitlist Available

Research Sponsored by Siva Health AG

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up first 24 hours

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a wearable device called SIVA-MVP that tracks how often people with chronic cough or asthma cough. The device helps doctors monitor coughing patterns by automatically recording each cough and sending the data to a smartphone app.

Who is the study for?

This trial is for adults who can consent and communicate in English, have chronic cough or diagnosed asthma, are comfortable using a smartphone, and will use an iPhone daily. It's not for those using certain medical devices, with substance abuse issues, involved in other studies, unable to consent or follow the study protocol due to health reasons, or women of childbearing potential without a negative pregnancy test.

What is being tested?

The SIVA-MVP device is being tested for its ability to automatically measure cough frequency in patients with chronic cough. The study involves continuous monitoring in a real-world setting to validate the effectiveness of this non-CE marked medical device.

What are the potential side effects?

Since this trial tests a medical device that monitors cough frequency rather than medication or invasive procedures, side effects may be minimal but could include discomfort from wearing the device or skin irritation.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ first 24 hours

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~first 24 hours

This trial's timeline: 3 weeks for screening, Varies for treatment, and first 24 hours for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Performance of the SIVA-MVP cough detection device

Secondary study objectives

Comparison of objectively recorded (device) data and subjectively reported (patient) data measured with Leicester Cough Questionnaire and Cough Severity VAS

Cough frequency patterns

Effective reply rate

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: SIVA-MVPExperimental Treatment1 Intervention

Wearable cough detection device with a corresponding smartphone application and charging device.

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Chronic Bronchitis include mucoactive agents and mechanical devices that aid in mucus clearance. Mucoactive agents, such as N-acetylcysteine and carbocysteine, work by breaking down mucus, making it less viscous and easier to expel, which helps to clear the airways and reduce cough frequency. Mechanical devices, like oscillating positive expiratory pressure (PEP) devices, create vibrations that loosen mucus from the airway walls, facilitating its removal. These treatments are crucial for Chronic Bronchitis patients as they help to manage chronic cough, improve breathing, and reduce the risk of infections and exacerbations.

[Respiratory physiotherapy in acute viral bronchiolitis in the newborn. Pro/con arguments].