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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

• Change in hourly cough frequency [Срок оценки: 16 weeks]

Вторичные конечные точки (11)

• Change in FEV1 [Срок оценки: 16 weeks]
• Change in FVC [Срок оценки: 16 weeks]
• Change in Leicester Cough Questionnaire [Срок оценки: 16 weeks]
• Change in King's Brief ILD Questionnaire [Срок оценки: 16 weeks]
• Change in sputum total cell count [Срок оценки: 16 weeks]
• Change in sputum neutrophils [Срок оценки: 16 weeks]
• Change in sputum eosinophils [Срок оценки: 16 weeks]
• Adverse events [Срок оценки: 16 weeks]
• Serious adverse events [Срок оценки: 16 weeks]
• Completion rates for Bi-weekly LCQ [Срок оценки: 16 weeks]
• Study medication adherence rate [Срок оценки: 16 weeks]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Канада · 1 центр

• St. Joseph's Healthcare Hamilton — Hamilton

Идентификаторы

NCT: NCT05086432 · 13513

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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