Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT05086432

Sputum Cytometry Guided Management for the Elimination of Chronic Cough in Patients With ILD

Led by McMaster University · Updated on 2025-09-29

120

Participants Needed

1

Research Sites

92 weeks

Total Duration

On this page

Sponsors

M

McMaster University

Lead Sponsor

S

St. Joseph's Healthcare Hamilton

Collaborating Sponsor

AI-Summary

What this Trial Is About

In Interstitial Lung Disease (ILD) there is thickening of lung tissue, which makes it difficult for patients to breathe and get enough oxygen into their bodies. In addition to shortness of breath, daily cough is very common, with 4 out of 5 patients experiencing this symptom. Cough in particular has a major impact on the ability to exercise, be active, and to simply enjoy life. There are many reasons for cough in ILD, and very often there are multiple overlapping causes. It is hard to improve cough in these patients, with available medicines providing limited relief. One explanation for this gap is an incomplete understanding of cough in ILD. To improve patients' cough there is a need to better understand its cause. In other lung diseases, such as asthma, doctors and scientists have used phlegm tests to measure inflammation in the lung, which helps them choose the right medicine for the right patient. This has not been done for ILD, even though it has recently been found that many patients with ILD and everyday cough have abnormal phlegm tests. Using this strategy in ILD could improve patients' cough and quality of life, and possibly even slow progression of the disease.

CONDITIONS

Official Title

Sputum Cytometry Guided Management for the Elimination of Chronic Cough in Patients With ILD

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Signed informed consent before any study procedures
  • Age over 18 years
  • Clinical diagnosis of Interstitial Lung Disease including idiopathic pulmonary fibrosis, chronic hypersensitivity pneumonitis associated ILD, connective tissue disease associated ILD, or pneumoconiosis
  • Daily cough lasting at least 8 weeks
  • Ability to produce an adequate sputum sample through sputum induction
Not Eligible

You will not qualify if you...

  • Diagnosis of systemic sclerosis associated ILD or sarcoidosis
  • Cough caused by known reasons such as ACE-inhibitor use, uncontrolled gastroesophageal reflux, upper airway cough syndrome, or acute viral illness
  • Current use of inhaled corticosteroids
  • Current use of systemic corticosteroids (prednisone equivalent over 20mg/day)
  • Current use of chronic antibiotics
  • Airflow obstruction with pre-bronchodilator FEV1/FVC ratio below 0.7
  • History of physician-diagnosed asthma or emphysema
  • History of cholestatic jaundice or liver dysfunction linked to previous azithromycin use
  • Moderate to severe liver dysfunction with Child Pugh score over 10
  • Known allergy or sensitivity to inhaled corticosteroids or macrolide antibiotics
  • Corrected QT interval on ECG over 450ms
  • Untreated atypical mycobacterial infection
  • History of hearing problems, tinnitus, or vertigo
  • Use of medications likely to suppress cough such as morphine, gabapentin, or amitriptyline

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

St. Joseph's Healthcare Hamilton

Hamilton, Ontario, Canada, L8N 4A6

Actively Recruiting

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Research Team

C

Ciaran Scallan, MB

CONTACT

T

Terence Ho, MB, MSc

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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