Sputum-guided Management for Interstitial Lung Disease
(SpECC-ILD Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to assist individuals with Interstitial Lung Disease (ILD) who experience a persistent daily cough. Researchers are testing a new approach called sputum-guided management, which uses phlegm tests to better understand and treat airway inflammation. Participants will receive either standard care or this new treatment to determine if it improves their cough and quality of life. This trial may suit those with ILD who have had a daily cough for at least 8 weeks and can produce a phlegm sample. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance treatment strategies for ILD.
Do I have to stop taking my current medications for the trial?
Yes, you may need to stop certain medications. The trial excludes participants who are currently using inhaled or systemic corticosteroids, chronic antibiotics, or medications that suppress cough like morphine, gabapentin, or amitriptyline.
What prior data suggests that this sputum-guided management is safe for interstitial lung disease?
Research has shown that using sputum to guide treatment is generally safe for people with interstitial lung disease (ILD). In past studies, patients responded well to this method. Importantly, no one experienced severe side effects like excessive airway tightening, which can make breathing difficult. This indicates that the treatment did not significantly reduce lung function, a positive sign for safety.
Additionally, inhaled corticosteroids and Azithromycin, part of this treatment plan, are commonly used in medical practice to treat lung swelling and infections. While side effects can occur with any treatment, research so far suggests that this approach is promising and manageable for patients.12345Why are researchers excited about this trial?
Unlike standard treatments for interstitial lung disease (ILD) that primarily rely on medications like corticosteroids, the sputum-guided management approach customizes therapy based on the specific type of airway inflammation present. This method uses sputum analysis to identify whether eosinophils or neutrophils are causing inflammation and tailors treatment accordingly, such as using inhaled corticosteroids for eosinophilic inflammation or Azithromycin for neutrophilic inflammation. Researchers are excited because this targeted approach could lead to more effective management of ILD by addressing the root cause of inflammation, potentially improving outcomes and reducing unnecessary medication use.
What evidence suggests that sputum-guided management is effective for improving cough in interstitial lung disease?
Research has shown that using sputum (phlegm) tests to guide treatment can benefit people with Interstitial Lung Disease (ILD) who have a persistent cough. This trial will compare standard care with sputum-guided management. The sputum-guided management arm involves checking the phlegm to identify specific types of lung inflammation, such as eosinophilia, where a certain type of white blood cell is higher than normal. One study found that treating this inflammation with inhaled medications like corticosteroids improved lung function. Specifically, it increased FEV1, which measures how much air a person can forcefully exhale in one second, by 120 mL. It also helped maintain stable lung capacity, as measured by FVC, compared to those not using this method. This suggests that targeting specific types of inflammation can reduce coughing and improve the quality of life for ILD patients.26789
Are You a Good Fit for This Trial?
This trial is for patients with Interstitial Lung Disease who have a daily cough lasting at least 8 weeks. They must be able to provide a sputum sample and have specific types of ILD, such as IPF, CHP-ILD, CTD-ILD, or Pneumoconiosis. Participants need to give written consent before any study procedures.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either sputum-guided management or standard care for airway inflammation over 16 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Sputum-guided management
Find a Clinic Near You
Who Is Running the Clinical Trial?
McMaster University
Lead Sponsor
St. Joseph's Healthcare Hamilton
Collaborator
Vitalograph
Collaborator