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

NCT05086432 | Recruiting

• 1 other identifier: 13513
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

ILD

Keywords

ILD; Sputum; Chronic cough

Outcome Measures

Primary Outcomes (1)

• Change in hourly cough frequency

  The difference in hourly cough frequency over a 24-hour period between baseline and end of study.

  16 weeks

Secondary Outcomes (11)

• Change in FEV1

  16 weeks

• Change in FVC

  16 weeks

• Change in Leicester Cough Questionnaire

  16 weeks

• Change in King's Brief ILD Questionnaire

  16 weeks

• Change in sputum total cell count

  16 weeks

Study Arms (2)

Sputum-guided management

EXPERIMENTAL

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.

Other: Sputum-guided management

Standard of Care

ACTIVE COMPARATOR

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.

Other: Standard of Care

Interventions

Sputum-guided management OTHER

As previously described.

Sputum-guided management

Standard of Care OTHER

As previously described.

Standard of Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patients with a diagnosis of systemic sclerosis associated ILD (SSc-ILD) or sarcoidosis
• Cause of cough attributed to a known etiology (ex. ACE-inhibitor, uncontrolled gastroesophageal reflux or upper airway cough syndrome, acute viral illness)
• Current use of inhaled corticosteroids
• Current use of systemic corticosteroids (prednisone equivalent \> 20mg/day)
• Current use of chronic antibiotics
• Airflow obstruction (ie. pre-bronchodilator FEV1/FVC ratio \< 0.7)
• History of physician-diagnosed asthma
• History of emphysema
• A history of cholestatic jaundice or hepatic dysfunction associated with prior use of azithromycin
• Moderate to severe hepatic dysfunction with a Child Pugh score \>10
• Known allergy or hypersensitivity to inhaled corticosteroids or macrolide antibiotics
• Corrected QT-interval (QTc) on screening electrocardiogram (ECG) of \> 450ms
• An established history of untreated atypical mycobacterial infection
• A history of hearing impairment, tinnitus, or vertigo
• Medication use likely to suppress cough (ex: morphine, gabapentin, amitriptyline)

Sponsors & Collaborators

• McMaster University: lead
• St. Joseph's Healthcare Hamilton: collaborator
• Vitalograph: collaborator

Study Sites (1)

St. Joseph's Healthcare Hamilton

Hamilton, Ontario, L8N 4A6, Canada

RECRUITING

MeSH Terms

Conditions

Chronic Cough

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Cough; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Central Study Contacts

Ciaran Scallan, MB

CONTACT

9055221155; scallc@mcmaster.ca

Terence Ho, MB, MSc

CONTACT

9055221155; hot4@mcmaster.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2021
• First Posted: October 20, 2021
• Study Start: May 22, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: September 29, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)