Azathioprine and Prednisone in the Treatment of Idiopathic Pulmonary Fibrosis
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|ClinicalTrials.gov Identifier: NCT00518310|
Recruitment Status : Unknown
Verified August 2007 by Thorax National Institute.
Recruitment status was: Recruiting
First Posted : August 20, 2007
Last Update Posted : August 20, 2007
|First Submitted Date ICMJE||August 16, 2007|
|First Posted Date ICMJE||August 20, 2007|
|Last Update Posted Date||August 20, 2007|
|Start Date ICMJE||May 2005|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
||Progression-free survival, defined as free of death or a decrease from baseline in the FVC of at least 10%. [ Time Frame: 2 years ]|
|Original Primary Outcome Measures ICMJE||Same as current|
|Change History||No Changes Posted|
|Current Secondary Outcome Measures ICMJE
|Original Secondary Outcome Measures ICMJE||Same as current|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Azathioprine and Prednisone in the Treatment of Idiopathic Pulmonary Fibrosis|
|Official Title ICMJE||Azathioprine and Prednisone in the Treatment of Idiopathic Pulmonary Fibrosis: a Randomized, Double-Blind, Controlled Study|
Idiopathic pulmonary fibrosis (IPF) is a diffuse lung disease, associated with the histological appearance of usual interstitial pneumonia (UIP), with an inexorably deteriorating clinical course. Prognosis is poor, reported median survival is less than 3 years. The prevalence is estimated as being 3 to 10 per 100.000 in different Western populations. To date, no pharmacological therapy has been proven to alter or reverse the pathogenic process of IPF. Most treatments trials have been observational case series of small patient populations and very few have been randomized, prospective and placebo-controlled.
Two recent Cochrane reviews investigated the role of corticosteroids and other immunomodulatory agents and concluded that there is no evidence for their use in IPF. Most current therapies are targeted to suppress the inflammatory component of the disease, based on the theory that it would be chronic alveolar inflammation which leads to parenchymal remodeling and fibrosis. Recently, a hypothesis that has gained acceptance suggests that fibrosis may result directly from alveolar injury, promoting an abnormal fibrogenic repair mediated by fibroblasts and myofibroblasts.
One of the cytotoxic agents most widely used and better tolerated in the management of IPF is azathioprine. Based upon limited data available and from a single small high quality randomized controlled trial (RCT), this drug appears to confer, given in conjunction with prednisone, a marginal long term survival advantage. Since this combination therapy is associated serious adverse effect, we planned to design a trial of low dose corticosteroid and azathioprine versus placebo in management of IPF, evaluating progression-free survival.
Our study hypothesis is: Combined therapy with azathioprine and corticosteroids improves progression-free survival in patients with the diagnosis of IPF.
We will evaluate all adult patients consecutively referred from March 2005 to the Instituto Nacional del Tórax (Thorax National Institute), Santiago, Chile for diagnostic evaluation of Pulmonary Fibrosis. The routine evaluation will include, when indicated, the following steps:
Those patients with IPF diagnosed on the basis of clinical and radiographic criteria alone according to the ATS/ERS consensus committee (3), and/or with a biopsy proven histological pattern of UIP, will be selected to the randomization process, after they have signed the written informed consent.
|Study Type ICMJE||Interventional|
|Study Phase||Not Provided|
|Study Design ICMJE||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Condition ICMJE||Idiopathic Pulmonary Fibrosis|
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Unknown status|
|Estimated Enrollment ICMJE||100|
|Estimated Completion Date||December 2008|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
|Ages||45 Years to 79 Years (Adult, Senior)|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||Chile|
|Removed Location Countries|
|NCT Number ICMJE||NCT00518310|
|Other Study ID Numbers ICMJE||10351|
|Has Data Monitoring Committee||Yes|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||Thorax National Institute|
|PRS Account||Thorax National Institute|
|Verification Date||August 2007|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP