What side effects are associated with this type of intervention?

The most common treatment for silicosis involves the use of respirators to physically block silica inhalation, which has no direct side effects but requires proper usage and fit to be effective. Other treatments include inhaled corticosteroids, which can cause side effects such as oral thrush, hoarseness, and an increased risk of fractures with long-term use. Bronchodilators, another common treatment, may lead to side effects like tremors, palpitations, and headaches. Ensuring proper use and monitoring can help mitigate these side effects.

What prior FDA approvals exist?

There are no specific FDA-approved treatments for silicosis mentioned in the provided context. However, a promising intervention involves the use of personal protective equipment (PPE), specifically respirators, to decrease silica inhalation and reduce the risk of developing silicosis. This approach is being studied as a preventive measure for workers exposed to high levels of respirable silica, such as those in the brick manufacturing industry.

What other types of research exist?

Promising novel alternatives to respirators for decreasing silica inhalation in silicosis patients include: 1) Advanced air filtration systems in work environments to reduce ambient silica levels, 2) Nanomaterial-based coatings on surfaces to trap silica particles, 3) Wearable air purification devices that filter air before inhalation, and 4) Implementation of automated, enclosed systems for high-risk tasks to minimize direct human exposure.

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PPE and Training for Silicosis

N/A

Waitlist Available

Led By William Checkley, MD, PhD

Research Sponsored by Johns Hopkins University

Eligibility Criteria Checklist

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

Must have

Cognitively capable to provide informed consent

Age 18 years or older

Must not have

Less than 18 years old

Not cognitively capable to provide informed consent

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to protect brick kiln workers in Nepal from silicosis by giving them respirators and training them on how to use these devices. The study will assess workers' current knowledge, design a training program, and test its effectiveness in reducing silica exposure.

Who is the study for?

This trial is for adult brick kiln workers in Bhaktapur, Nepal who are at risk of silicosis due to silica exposure. Participants must be over 18 years old and able to give informed consent. It excludes those not working in brick kilns, under 18, or unable to consent.

What is being tested?

The study tests a training program on using personal protective equipment (PPE) like N95 respirators and protective eyewear to reduce silica inhalation among workers. The intervention includes a workshop designed with the Discover, Design, Build, Test framework.

What are the potential side effects?

There may be no direct medical side effects from participating as this trial focuses on educational interventions and PPE use. However, discomfort or difficulty wearing PPE such as respirators could occur.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am mentally able to understand and agree to the study's procedures.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am under 18 years old.

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I am unable to understand and give consent for treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Feasibility as assessed by The Feasibility of Intervention Measure (FIM) score

Awards & Highlights

No Placebo-Only Group

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

Trial Design

4Treatment groups

Experimental Treatment

Group I: Pilot Study: Personal Protective Equipment Training ProgramExperimental Treatment2 Interventions

A small training program will be offered to brick kiln workers to determine preferred PPE type, feasibility in the work environment and proper usage of PPE.

Group II: Feedback Workshop on Pilot Personal Protective Equipment Training ProgramExperimental Treatment1 Intervention

Group III: Design of Personal Protective Equipment Training WorkshopExperimental Treatment1 Intervention

Group IV: Baseline Survey: Silicosis and Personal Protective EquipmentExperimental Treatment1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

N95 Respirator

2019

N/A

~3050

Protective Eyewear

2024

N/A

~100

0 / 4Eligibility criteria met

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 silicosis include the use of respirators to prevent silica inhalation, bronchodilators to ease breathing, and corticosteroids to reduce inflammation. Respirators act as a physical barrier, preventing silica particles from entering the lungs, which is crucial in halting the progression of the disease. Bronchodilators help to open the airways, making it easier for patients to breathe, while corticosteroids reduce lung inflammation, alleviating symptoms and preventing further lung damage. These treatments are vital for silicosis patients as they address both the prevention of further silica exposure and the management of existing symptoms, thereby improving quality of life and reducing the risk of severe complications.

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