Sputum Cytometry Guided Management for the Elimination of Chronic Cough in Patients With Interstitial Lung Disease (SpECC-ILD) - a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Change in hourly cough frequency
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
研究组 & 干预措施
Sputum-guided management
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.
干预措施: Sputum-guided management (Other)
Standard of Care
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.
干预措施: Standard of Care (Other)
结局指标
主要结局
Change in hourly cough frequency
时间窗: 16 weeks
The difference in hourly cough frequency over a 24-hour period between baseline and end of study.
次要结局
- Change in Leicester Cough Questionnaire(16 weeks)
- Change in sputum eosinophils(16 weeks)
- Study medication adherence rate(16 weeks)
- Change in FEV1(16 weeks)
- Completion rates for Bi-weekly LCQ(16 weeks)
- Change in King's Brief ILD Questionnaire(16 weeks)
- Change in sputum total cell count(16 weeks)
- Change in sputum neutrophils(16 weeks)
- Adverse events(16 weeks)
- Serious adverse events(16 weeks)
- Change in FVC(16 weeks)