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
Trial Overview
The trial is testing if managing chronic cough in ILD patients using sputum cytometry (phlegm tests) can improve their condition compared to standard care. It aims to tailor treatment based on inflammation levels detected in the phlegm.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
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.
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
McMaster University
Lead Sponsor
St. Joseph's Healthcare Hamilton
Collaborator
Vitalograph
Collaborator
Citations
Sputum-guided Management for Interstitial Lung Disease
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 ...
Sputum quantitative cytometry in patients with interstitial ...
Sputum-guided management of airway eosinophilia was associated with improvements in FEV1 (+120 vs -205mL, p < 0.0001) and stability of FVC (+13 vs -284mL, p = ...
Examining Cough's Role and Relief Strategies in Interstitial ...
Chronic cough in ILD is a significant outcome measure of the management of ILD [3], which is often refractory to conventional therapeutic interventions. The ...
ICU Management of the Patient With Fibrotic Interstitial ...
This review summarizes an approach to the evaluation and management of patients presenting to the ICU through a discussion of: (1) diagnosis of acute ...
Drug-induced interstitial lung disease during cancer ...
These recommendations provide a structured step-by-step diagnostic and therapeutic approach for each grade of suspected cancer-related DIILD.
Sputum quantitative cytometry in patients with interstitial ...
Sputum-guided management of airway eosinophilia was associated with improvements in FEV1 (+120 vs −205mL, p < 0.0001) and stability of FVC (+13 vs −284mL, p = ...
Sputum quantitative cytometry in patients with interstitial ...
Sputum-guided management of airway eosin- ophilia was associated with improvements in FEV1 (þ120 vs 205mL, p < 0.0001) and stability of FVC (þ13 ...
Induced sputum: current progress and prospect - PMC
In conditions like interstitial lung disease, where patients often have a dry cough, induced sputum shows promise, albeit with limited research.
Safety of Sputum Induction in Interstitial Lung Disease
Results: The procedure was well tolerated, and none of the patients experienced excessive bronchoconstriction, defined as a fall in FEV1 of ≥20%. Nine patients ...
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