Cough Control Therapy for Cough

Recruiting at 2 trial locations

Overseen By Ana Oliveira, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: West Park Healthcare Centre

Must not be taking: ACE inhibitors

Disqualifiers: Sputum production, Recent infection, Bronchiectasis, others

Stay on Your Current Meds You can continue your current medications while participating

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

24 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method to assist individuals with interstitial lung disease (ILD) who have been coughing for over 8 weeks. The goal is to determine if a non-drug therapy, known as Non-pharmacological Cough Control Therapy, can lessen the impact of coughing on daily life by teaching self-management techniques. This approach includes four virtual sessions focused on cough control and breathing exercises. Individuals diagnosed with ILD and experiencing a persistent cough may be suitable candidates. As an unphased trial, this study provides patients the chance to explore innovative therapies that may enhance their quality of life.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you've changed your prescribed medication in the past month.

What prior data suggests that this non-pharmacological cough control therapy is safe for individuals with ILD?

Research has shown that non-drug cough control therapy is generally safe and easy to manage. In one study, 148 out of 173 patients reported improvement in their cough with this treatment, and no major side effects occurred. Unlike medications, these non-drug methods do not appear to cause harmful side effects. They focus on techniques to manage cough without medicine, which is beneficial since many cough medicines often have unwanted side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about non-pharmacological cough control therapy because it offers a fresh approach to managing coughs without medication. Unlike traditional treatments that often rely on cough suppressants or expectorants, this therapy focuses on educational and self-management strategies tailored to each participant's specific needs. The therapy includes techniques like breathing pattern retraining and laryngeal hygiene, aiming to empower individuals to control their coughs naturally. This approach not only addresses the physical aspect of the cough but also considers the psychological and behavioral components, potentially leading to more holistic and sustainable outcomes.

What evidence suggests that this non-pharmacological cough control therapy is effective for chronic cough in ILD?

Research has shown that non-drug treatments can help control long-term cough. In this trial, participants will receive non-pharmacological cough control therapy, including educational and self-management sessions. One study found that 85.5% of patients experienced improvement in their cough symptoms. Other research indicates that these treatments can greatly enhance quality of life by reducing cough frequency and sleep disruption. Additionally, these treatments help manage cough without the side effects often associated with medications, making them a promising option for those seeking to improve daily life without relying on drugs. ^{1 3 6 7 8}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Confirmed diagnosis of any ILD by a physician (as per Canadian Thoracic Society's guideline for evaluating patients with fibrotic interstitial lung disease)

Chronic cough lasting more than 8 weeks in duration

Exclusion Criteria

Changes in the prescribed medication in the previous month

Self-reports of moderate or large sputum production

Effective or suspected exacerbation of the respiratory condition in the past month

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pulmonary Rehabilitation

Participants are enrolled in a pulmonary rehabilitation program composed of aerobic and strengthening exercises, disease-specific education, and self-management

8 weeks

Virtual meetings via Zoom Healthcare Plan

Non-pharmacological Cough Control Therapy

Participants attend four virtual sessions of educational and self-management therapy targeting cough control

2 weeks

4 virtual sessions (45 to 60 minutes each)

Follow-up

Participants are monitored for safety and effectiveness after the intervention

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Non-pharmacological Cough control Therapy

Trial Overview 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.

How Is the Trial Designed?

Group I: Non-pharmacological Cough control therapy Experimental Treatment 1 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

Who Is Running the Clinical Trial?

West Park Healthcare Centre

Lead Sponsor

Trials

36

Recruited

2,400+

St. Joseph's Healthcare Hamilton

Collaborator

Trials

203

Recruited

26,900+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9397766/

Non-pharmacological Management of Non-productive ... This systematic review summarizes the effectiveness of non-pharmacological chronic cough therapies in adults with non-productive refractory chronic cough or ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S240584402307559X

Management of non-pharmacologic therapy for chronic ... Cough-specific quality of life improved significantly after treatment. Both the cough frequency score and the sleep disturbance scores decreased significantly.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT04767074?term=GUAIFENESIN&viewType=Table&rank=8

A Non-pharmacological Cough Control Therapy This study aims to explore the feasibility and effectiveness of a non-pharmacological cough control therapy, as an adjuvant of pulmonary rehabilitation, in ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7073411/

Nonpharmacological cough control therapy for chronic ... 148 (85.5%) out of 173 patients reported improvement; treatment did not improve cough in 25 (14.4%) out of 173 patients. LCQ data pre- and post- ...

5. jaci-inpractice.org jaci-inpractice.org/article/S2213-2198(24)01254-6/abstract

Nonpharmacological Approaches to Chronic Cough Effectiveness of the therapy program for management of chronic cough: preliminary data from a randomized clinical trial. Am J Speech Lang Pathol. 2022; 31 ...

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2213219824012546

Nonpharmacological Approaches to Chronic Cough The most widely reported nonpharmacological intervention for the management of chronic cough is cough control therapy typically provided by speech language ...

7. cell.com cell.com/heliyon/fulltext/S2405-8440(23)07559-X

Management of non-pharmacologic therapy for chronic ... Compared to pharmacologic therapy, non-pharmacologic therapy has no apparent adverse reactions. As such, non-pharmacologic therapy has good ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6026258/

Pharmacologic and Nonpharmacologic Treatment for Acute ... In adult patients with cough due to the common cold, we suggest against the use of nonsteroidal anti-inflammatory agents until they have been shown to make ...