Sputum Cytometry Guided Management for the Elimination of Chronic Cough in Patients With ILD (SpECC-ILD)

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

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.

Study Overview

• Status: Recruiting
• Conditions: ILD
• Intervention / Treatment: Other: Sputum-guided management; Other: Standard of Care

Detailed Description

SpECC-ILD is an open-label, randomized controlled trial assessing the efficacy of sputum-guided management (using sputum cytometry) compared to standard care over 16 weeks in patients with chronic cough and ILD.

A total of 80 participants will be enrolled and randomized in a 1:1 ratio to either sputum guided therapy or standard of care for a total of 16 weeks. Participants randomized to the intervention arm will receive open-label sputum-guided management of airway inflammation identified during screening. 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.

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ciaran Scallan, MB; Phone Number: 34330 9055221155; Email: scallc@mcmaster.ca
• Study Contact Backup: Name: Terence Ho, MB, MSc; Phone Number: 32995 9055221155; Email: hot4@mcmaster.ca

Study Locations

• Canada
  • Ontario
    • Hamilton, Ontario, Canada, L8N 4A6
      • Recruiting
      • St. Joseph's Healthcare Hamilton
      • Principal Investigator: Terence Ho, MB MSc
      • Contact: Terence Ho, MB MSc; Phone Number: Ext. 32995 905-522-1155; Email: hot4@mcmaster.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Other: Sputum-guided management; As previously described.
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.	Other: Standard of Care; As previously described.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in FEV1	The difference in forced expiratory volume in 1 second (as obtained by spirometry) between baseline and end of study	16 weeks
Change in FVC	The difference in forced vital capacity (as obtained by spirometry) between baseline and end of study	16 weeks
Change in Leicester Cough Questionnaire	The difference in LCQ between baseline and end of study	16 weeks
Change in King's Brief ILD Questionnaire	The difference in KB-ILD between baseline and end of study	16 weeks
Change in sputum total cell count	The difference in sputum total cell count between baseline and end of study	16 weeks
Change in sputum neutrophils	The difference in sputum neutrophil percent between baseline and end of study	16 weeks
Change in sputum eosinophils	The difference in sputum eosinophil percent between baseline and end of study	16 weeks
Adverse events	Adverse events reported by participants	16 weeks
Serious adverse events	Serious adverse events reported by participants	16 weeks
Completion rates for Bi-weekly LCQ	Rates of completion for bi-weekly LCQ	16 weeks
Study medication adherence rate	Rates of adherence to study medications	16 weeks

Collaborators and Investigators

• Sponsor: McMaster University
• Collaborators: St. Joseph's Healthcare Hamilton; Vitalograph

Study record dates

Study Major Dates

• Study Start (Actual): May 22, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027

Study Registration Dates

• First Submitted: September 28, 2021
• First Submitted That Met QC Criteria: October 19, 2021
• First Posted (Actual): October 20, 2021

Study Record Updates

• Last Update Posted (Estimated): September 29, 2025
• Last Update Submitted That Met QC Criteria: September 24, 2025
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: ILD; Sputum; Chronic cough
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Cough; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Chronic Cough; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality of Health Care; Quality Indicators, Health Care; Standard of Care
• Other Study ID Numbers: 13513

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No