Sputum Cytometry Guided Management for the Elimination of Chronic Cough in Patients With ILD

ILD Clinical Trial

— SpECC-ILD  

Official title:

Sputum Cytometry Guided Management for the Elimination of Chronic Cough in Patients With Interstitial Lung Disease (SpECC-ILD) - a Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05086432
• Other study ID #: 13513
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 2024
• Est. completion date: March 2025

Study information

• Verified date: March 2024
• Source: McMaster University
• Contact: Ciaran Scallan, MB
• Phone: 9055221155
• Email: scallc[@]mcmaster.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

SpECC-ILD is an open-label, randomized controlled trial assessing the efficacy of sputum-guided management (using sputum cytometry) compared to standard care over 16 weeks in patients with chronic cough and ILD. A total of 80 participants will be enrolled and randomized in a 1:1 ratio to either sputum guided therapy or standard of care for a total of 16 weeks. Participants randomized to the intervention arm will receive open-label sputum-guided management of airway inflammation identified during screening. 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: March 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Chronic Cough
• ILD

Intervention

Other:
• Sputum-guided management
As previously described.
• Standard of Care
As previously described.

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
McMaster University	St. Joseph's Healthcare Hamilton, Vitalograph

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in hourly cough frequency	The difference in hourly cough frequency over a 24-hour period between baseline and end of study.	16 weeks
Secondary	Change in FEV1	The difference in forced expiratory volume in 1 second (as obtained by spirometry) between baseline and end of study	16 weeks
Secondary	Change in FVC	The difference in forced vital capacity (as obtained by spirometry) between baseline and end of study	16 weeks
Secondary	Change in Leicester Cough Questionnaire	The difference in LCQ between baseline and end of study	16 weeks
Secondary	Change in King's Brief ILD Questionnaire	The difference in KB-ILD between baseline and end of study	16 weeks
Secondary	Change in sputum total cell count	The difference in sputum total cell count between baseline and end of study	16 weeks
Secondary	Change in sputum neutrophils	The difference in sputum neutrophil percent between baseline and end of study	16 weeks
Secondary	Change in sputum eosinophils	The difference in sputum eosinophil percent between baseline and end of study	16 weeks
Secondary	Adverse events	Adverse events reported by participants	16 weeks
Secondary	Serious adverse events	Serious adverse events reported by participants	16 weeks
Secondary	Completion rates for Bi-weekly LCQ	Rates of completion for bi-weekly LCQ	16 weeks
Secondary	Study medication adherence rate	Rates of adherence to study medications	16 weeks