What side effects are associated with this type of intervention?

Non-pharmacological treatments for Pulmonary Fibrosis, such as behavioral and physical techniques to control cough, generally have minimal side effects compared to pharmacological treatments. These interventions may include pulmonary rehabilitation, breathing exercises, and cough suppression techniques. Potential side effects are usually mild and can include temporary discomfort or fatigue from physical exercises, and in rare cases, dizziness or shortness of breath during intense sessions. Overall, these approaches are considered safe and beneficial for managing symptoms without the significant side effects associated with drug therapies.

What prior FDA approvals exist?

The FDA has approved antifibrotic agents such as nintedanib and pirfenidone for the treatment of Pulmonary Fibrosis. These medications aim to slow disease progression by targeting fibrotic pathways. In contrast, the non-pharmacological cough control therapy being studied focuses on behavioral and physical techniques to reduce cough severity and impact, offering a drug-free alternative to manage symptoms associated with Interstitial Lung Disease (ILD).

What other types of research exist?

Promising novel alternatives to non-pharmacological cough control therapy for pulmonary fibrosis patients include: 1) Advanced inhalation therapies such as breath-enhanced and breath-actuated inhalers, which offer improved drug delivery and patient compliance. 2) Ultrasonic nebulization platforms that provide efficient and personalized drug delivery. 3) Oscillatory Positive Expiratory Pressure (OPEP) devices, which help in sputum clearance and may reduce cough severity. These alternatives leverage recent technological advancements to potentially improve the management of cough in pulmonary fibrosis patients.

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Cough Control Therapy for Cough

N/A

Recruiting

Research Sponsored by West Park Healthcare Centre

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 through study completion, average 1 year

Awards & highlights

Summary

This trial aims to test a non-drug therapy to help adults with ILD manage their chronic cough. The therapy involves educational sessions that teach patients how to control their coughing. This approach is being tested because current drug treatments are not very effective and have significant side effects.

Who is the study for?

This trial is for individuals with any type of Interstitial Lung Disease (ILD) who have been coughing for more than 8 weeks. They must not have had changes in medication, respiratory exacerbations, or upper respiratory infections in the past month and should be able to perform exercise training.

What is being tested?

The study tests a non-drug cough control therapy as an addition to pulmonary rehabilitation for ILD patients with chronic cough. It aims to see if this therapy can reduce the severity and impact of cough without using medications.

What are the potential side effects?

Since the intervention is non-pharmacological, it's expected to have minimal side effects compared to drug treatments. However, specific side effects are not detailed as they may vary depending on individual patient responses.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, average 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, average 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, average 1 year 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 of intervention

Secondary study objectives

Cough Hypersensitivity Questionnaire (CHQ)

Functional Assessment of Chronic Illness Therapy Fatigue Scale (FACIT-F)

Global rating of change questionnaire (GRCQ)

+4 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Non-pharmacological Cough control therapyExperimental Treatment1 Intervention

Participants will attend four virtual sessions of 45 to 60 minutes of educational and self-management. Sessions will be designed to target participants' needs and expectations according to the semi-structured theme. Session 1 General assessment Prescription of cough technique Session 2 Cough principles of cough Cough control Session 3 Breathing pattern retraining and laryngeal hygiene Session 4 Reinforcement of cough control therapies

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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

Non-pharmacological treatments for Pulmonary Fibrosis, such as the cough control therapy being studied, primarily involve behavioral and physical techniques aimed at reducing cough severity and its impact on daily life. These methods may include breathing exercises, cough suppression techniques, and pulmonary rehabilitation. Breathing exercises help improve lung function and oxygenation, while cough suppression techniques teach patients how to control and minimize coughing episodes. Pulmonary rehabilitation combines exercise training, education, and support to enhance overall physical conditioning and respiratory efficiency. These approaches are crucial for Pulmonary Fibrosis patients as they can alleviate physical discomfort, reduce psychological stress, and improve social interactions, thereby enhancing the quality of life.

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Who is running the clinical trial?

West Park Healthcare CentreLead Sponsor

34 Previous Clinical Trials

2,292 Total Patients Enrolled

1 Trials studying Pulmonary Fibrosis

50 Patients Enrolled for Pulmonary Fibrosis

St. Joseph's Healthcare HamiltonOTHER

199 Previous Clinical Trials

26,657 Total Patients Enrolled

1 Trials studying Pulmonary Fibrosis

60 Patients Enrolled for Pulmonary Fibrosis

Media Library

Non-pharmacological Cough control Therapy Clinical Trial Eligibility Overview. Trial Name: NCT04767074 — N/A

Pulmonary Fibrosis Research Study Groups: Non-pharmacological Cough control therapy

Pulmonary Fibrosis Clinical Trial 2023: Non-pharmacological Cough control Therapy Highlights & Side Effects. Trial Name: NCT04767074 — N/A

Non-pharmacological Cough control Therapy 2023 Treatment Timeline for Medical Study. Trial Name: NCT04767074 — N/A

~1 spots leftby Dec 2024

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