Sputum test–guided treatment to eliminate chronic cough in people with ILD
Sputum Cytometry Guided Management for the Elimination of Chronic Cough in Patients With Interstitial Lung Disease (SpECC-ILD) - a Randomized Controlled Trial
This trial will test whether using sputum cell counts to guide treatment can reduce chronic cough in adults with interstitial lung disease.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | McMaster University Academic / other |
| Drugs / interventions | prednisone |
| Locations | 1 site (Hamilton, Ontario) |
| Trial ID | NCT05086432 on ClinicalTrials.gov |
What this trial studies
SpECC-ILD is an open-label, randomized controlled trial that will enroll 80 adults with ILD and daily cough to compare sputum-guided management versus standard care over 16 weeks. Participants are randomized 1:1 to either sputum cytometry–guided therapy or standard of care; the intervention arm receives treatment directed by sputum inflammatory findings while treating ILD specialists remain blinded to sputum results. The primary approach uses induced sputum samples to identify airway inflammation and tailor anti-inflammatory or other therapies accordingly. Outcomes focus on cough improvement and related functional measures over the 16-week study period.
Who should consider this trial
Good fit: Adults over 18 with a clinical diagnosis of ILD (for example IPF, CHP-ILD, CTD-ILD, or pneumoconiosis) who have had daily cough for at least 8 weeks and can produce an adequate sputum sample are ideal candidates.
Not a fit: Patients with systemic sclerosis–associated ILD or sarcoidosis, a known non-respiratory cause of cough, current inhaled or high-dose systemic corticosteroid use, chronic antibiotics, or significant airflow obstruction are excluded and unlikely to benefit from this approach.
Why it matters
Potential benefit: If successful, sputum-guided treatment could reduce chronic cough and improve daily function by matching therapies to each patient’s airway inflammation.
How similar studies have performed: Sputum cytometry has been used successfully to guide treatment in asthma and other airway diseases, but applying this method to cough in ILD is a novel and not yet established approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
Hamilton, Ontario
- St. Joseph's Healthcare Hamilton — Hamilton, Ontario, Canada (Recruiting)
Study contacts
- Study coordinator: Ciaran Scallan, MB
- Email: scallc@mcmaster.ca
- Phone: 9055221155
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.