Clinical trial NCT05086432: Sputum Cytometry Guided Management for the Elimination of Chronic Cough in Patients With 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: ILD
Keywords: ILD
Sputum
Chronic cough
Lead sponsor: McMaster University
Sponsor class: OTHER
Collaborators: name: St. Joseph's Healthcare Hamilton
name: Vitalograph
First posted: 2021-10-20
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Change in hourly cough frequency
timeFrame: 16 weeks
Secondary outcomes:
measure: Change in FEV1
timeFrame: 16 weeks
measure: Change in FVC
timeFrame: 16 weeks
measure: Change in Leicester Cough Questionnaire
timeFrame: 16 weeks
measure: Change in King's Brief ILD Questionnaire
timeFrame: 16 weeks
measure: Change in sputum total cell count
timeFrame: 16 weeks
measure: Change in sputum neutrophils
timeFrame: 16 weeks
measure: Change in sputum eosinophils
timeFrame: 16 weeks
measure: Adverse events
timeFrame: 16 weeks
measure: Serious adverse events
timeFrame: 16 weeks
measure: Completion rates for Bi-weekly LCQ
timeFrame: 16 weeks
measure: Study medication adherence rate
timeFrame: 16 weeks
Other outcomes:
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