Recruiting

Cough in ILD

Sponsor:

McMaster University

Code:

NCT05086432

Conditions

ILD

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Sputum-guided management

Standard of Care

Study Details

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

Study ID

NCT05086432

Start date

May 22, 2025

Status verified date

Nov, 2024

Completion date

Mar, 2027

Anticipated

Primary completion date

Mar, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

Sputum-guided management

As previously described.

Standard of Care

As previously described.

Primary outcome measure

  • Change in hourly cough frequency [ Time Frame: 16 weeks ]

Central Contacts and Locations

Central contacts

Ciaran Scallan, MB

9055221155scallc@mcmaster.ca

Terence Ho, MB, MSc

9055221155hot4@mcmaster.ca

Locations

St. Joseph's Healthcare Hamilton

Recruiting

Hamilton, Ontario, Canada, L8N 4A6

Contacts

Terence Ho, MB MSc

905-522-1155hot4@mcmaster.ca

Principal Investigator:

Terence Ho, MB MSc

More Information

Sponsor

McMaster University

Last update posted

Sep 29, 2025

Last verified

Nov, 2024

Keywords

  • ILD
  • Sputum
  • Chronic cough

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by McMaster University on 2025-09-29.