Sputum test–guided treatment to eliminate chronic cough in people with ILD

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• St. Joseph's Healthcare Hamilton
  Hamilton, Ontario, Canada Recruiting

Study contacts

• Study coordinator: Ciaran Scallan, MB
• Email: scallc@mcmaster.ca
• Phone: 9055221155

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.