Sputum Cytometry Guided Management for the Elimination of Chronic Cough in Patients With Interstitial Lung Disease (SpECC-ILD) - a Randomized Controlled Trial

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Written informed consent consistent with ICH-GCP and local laws, signed prior to any study procedures being performed

• Age \>18 years

• A clinical diagnosis of ILD with accepted specific diagnoses including:

• Idiopathic pulmonary fibrosis (IPF)

• Chronic hypersensitivity pneumonitis associated ILD (CHP-ILD)

• Connective tissue disease associated ILD (CTD-ILD)

• Pneumoconiosis

• Daily Cough for at least 8 weeks

• Able to produce an adequate sample with sputum induction

Locations
Other Locations
Canada
St. Joseph's Healthcare Hamilton
RECRUITING
Hamilton
Contact Information
Primary
Ciaran Scallan, MB
scallc@mcmaster.ca
9055221155
Backup
Terence Ho, MB, MSc
hot4@mcmaster.ca
9055221155
Time Frame
Start Date: 2025-05-22
Estimated Completion Date: 2027-03
Participants
Target number of participants: 120
Treatments
Experimental: Sputum-guided management
During Weeks 0 to 16, participants randomized to the intervention arm will receive open-label sputum-guided management of airway inflammation (Table 1 in protocol) identified during screening (Figure 2 in protocol). Airway eosinophilia will be treated with regular inhaled corticosteroids based on the severity of eosinophilic inflammation. In participants with airway neutrophilia, as per the standard of care, sputum culture and sensitivity will be sent, and pathogenic organisms treated. Those participants with airway neutrophilia with negative cultures will be treated with thrice weekly Azithromycin (250mg). Combined eosinophilia and neutrophilia will receive treatment with both ICS and Azithromycin as per Table 2 in protocol.
Active_comparator: Standard of Care
Participants in this arm will receive standard of care treatment as determined by their ILD specialist who will be blinded to the results of the sputum analysis.
Sponsors
Collaborators: Vitalograph, St. Joseph's Healthcare Hamilton
Leads: McMaster University

This content was sourced from clinicaltrials.gov

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