Effectiveness and Pharmacoeconomic Study of Using Different Corticosteroids in the Treatment of Interstitial Lung Diseases
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 107
- 试验地点
- 1
- 主要终点
- Krebs von den Lungen - 6 (KL-6)
研究概览
简要总结
This was a 3 months prospective, open label, and parallel study to test the efficacy of 3 different corticosteroids in the management of interstitial lung diseases. Followed by a pharmacoeconomic analysis to find which regimen (betamethasone, dexamethasone or prednisolone) is the most cost-effective.
详细描述
Three different corticosteroid regimens were evaluated for the management of interstitial lung diseases (ILDs) with specific focus on hypersensitivity pneumonitis (HP) where the patients were divided into 3 treatment groups:
- Group I: patients receiving weekly pulse doses of betamethasone IM injection (equivalent dose to that of prednisolone daily dose in a week).
- Group II: patients receiving weekly pulse doses of dexamethasone IV injection (equivalent dose to that of prednisolone daily dose in a week).
- Group III: patients receiving oral prednisolone daily (dose range 15-20 mg/day).
10 mg oral prednisolone oral ≡ 1.5 mg dexamethasone intravenous ≡ 1.2 mg betamethasone intramuscular.
After the administration of the above-mentioned medications, the patients were followed-up over 3 months to evaluate their disease progression. Informed consent was obtained from all subjects or their surrogate after explanation and understanding of the nature, purpose, and potential risks of the study. The study protocol was approved by the Ethics Committee, Faculty of Pharmacy, Cairo University (protocol serial number: CL (2183)) .
A special patient information sheet was designed to collect all information required for data analysis. The sheet was designed to be divided into several sections:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with ILD (hypersensitivity pneumonitis) with age between18 and 65 years old.
- •Symptoms including dry cough and shortness of breath.
- •Significant decrease in pulmonary function (desaturation by 4% after 6-minute walk distance), where the patients were no more controlled on their prednisolone maintenance therapy (up to 10 mg/day).
- •Chest CT showing ground glass opacity and band of shadow.
排除标准
- •Patients with any other organ affliction (heart failure (ejection fraction 40-50%), renal failure (decrease in glomerular filtration rate > 75%), or liver cirrhosis (transient elastography liver stiffness measurements 12.5-75.5 kPa)).
- •Active infection.
- •Patients on other immunosuppressive medications (e.g., cyclophosphamide) and anti-fibrotic (e.g., interferon, pirfenidone, endothelin-1 antagonist and tumor necrosis factor α modulator).
- •History of pulmonary embolism (corticosteroids' use increase the risk of recurrence of pulmonary embolism).
- •Pregnancy.
研究组 & 干预措施
Betamethasone group
干预措施: Betamethasone, Dexamethasone, Prednisolone (Drug)
Dexamethasone group
干预措施: Betamethasone, Dexamethasone, Prednisolone (Drug)
Prednisolone group
干预措施: Betamethasone, Dexamethasone, Prednisolone (Drug)
结局指标
主要结局
Krebs von den Lungen - 6 (KL-6)
时间窗: 3 months
a high molecular weight mucin-like glycoprotein expressed on cell surface of alveolar epithelial cells. Elevated levels of KL-6 occur in ILDs and it is recently widely accepted as a biomarker for diagnosis and prognosis of ILDs. Measured as (U/ml) using ELISA
次要结局
- Respiratory Function Assessment; FEV1(3 months)
- Respiratory Function Assessment; 6MWD(3 months)
- Respiratory Function Assessment; % O2 desaturation(3 months)
- Respiratory Function Assessment; FVC(3 months)
- Respiratory Function Assessment; FEV/FVC Ratio(3 months)
研究者
Marwa G. Elhennawy
Assistant Lecturer
Cairo University