跳至主要内容
临床试验/CTRI/2011/11/002150
CTRI/2011/11/002150招募中不适用

Evaluation of the role of Doxycycline in Interstitial Lung Disease (ILD) /Diffuse Parenchymal Lung Disease (DPLD) in a real world observation

Institute of Pulmocare Research1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2008年2月5日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
60
试验地点
1
主要终点
At least no detoriation than before in subjective wellbeing of the patient and clinicoradiological and ±FVC changes.

研究概览

简要总结

ILD is a group of heterogeneous diseases from different etiologies with a common denominator of diffuse parenchymal involvement and destruction by predominant fibrosis. Several types of diseases are listed such as idiopathic interstitial pneumonias (IIP), collagen vascular diseases, occupational lung diseases, sarcoidosis etc apart from a lot of other relatively rare diseases Idiopathic pulmonary fibrosis (IPF), the most common variant of idiopathic interstitial pneumonias is studied most extensively amongst the ILDs. The mechanism of development of fibrosis in ILDs is not well elaborated in all the different etiological subcategories.

The role of MMPs appear critical in IPF and probably in other categories of IIPs and ILDs.Doxycycline is a non specific MMPs inhibitor and has shown beneficial effects in IPF with demonstration of reduction in the MMPs level in BALF .Though not studied, it is likely that MMPs plays a significant role in other varieties of DPLDs-where administration of  doxycycline in similar fashion may have a therapeutic rolexml:namespace prefix = o ns = "urn:schemas-microsoft-com:office:office" /

The proposed study will be a real world single arm prospective observational trial.  The selection criteria is not very strict as it prevails in existing practice of a physician in a developing country and the investigations will be done as far as possible to an extent the patient is willing or can afford to pay for in accordance with the prevailing circumstances.

Similarly, like a conventional trial there will be no fixed protocol for follow ups, though a regular requirement of review and monitoring will be suggested to each patient. Again, the volunteers will be requested to report for suspected adverse reaction, if any than looking such things on a stringent fashion as being done in a formal drug trial.

The evaluation process also will be far from ideal as is followed in a drug trial. However, it will be objective as far as possible in the available situation and the practice style.

All efforts will be exerted to extract the best possible information from the available records. The physician though not blinded will have full access into the record and power to modify the treatment as and when he or she feels it necessary. The etiological assessment and the severity evaluation will be done at the point of data collection only.

研究设计

研究类型
Interventional
分配方式
Not Applicable
盲法
Not Applicable

入排标准

年龄范围
30.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • Willing to give written informed consent
  • Clinically suspected patients with ILDs with the diagnosis being substantiated through chest X-ray(PA) and HRCT chest.

排除标准

  • 1.History of exacerbation in past 1 month 2.History of Doxy allergy 3.Having any obvious contraindication for Doxycycline 4.Unable to meet the demand of the protocol for any reason 5.Significant abnormality in liver or renal function
  • Feature of chronic congestive cardiac failure (supported by echocardiography) 7.Known case of Idiopathic pulmonary disease with cardiovascular disease.

结局指标

主要结局

At least no detoriation than before in subjective wellbeing of the patient and clinicoradiological and ±FVC changes.

时间窗: Between 12 weeks and 6 months after starting doxycycline with repeat spirometry.

次要结局

未报告次要终点

研究者

申办方类型
Research institution

研究点 (1)

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