Treating Interstitial Pneumonia with the Addition of Co-trimoxazole

niversity of East Anglia (UK)0 sites140 target enrollmentOctober 31, 2007

Overview

No summary available.

Registry

who.int

Start Date

October 31, 2007

End Date

TBD

Last Updated

9 years ago

Study Type

Interventional

Sex

All

Sponsor

niversity of East Anglia (UK)

•1\. Male or female, aged greater than 40 years
•2\. Female subjects must be of non\-childbearing potential, defined as follows:
•2\.1\. Postmenopausal females who have had at least 12 months of spontaneous amenorrhoea or 6 months of spontaneous amenorrhoea with serum Follicle Stimulating Hormone (FSH) greater than 40 mIU/ml
•2\.2\. Females who have had a hysterectomy or bilateral oophorectomy for at least 6 weeks
•3\. Able to provide informed consent
•4\. A clinical labelled diagnosis of fibrotic idiopathic interstitial pneumonia with High Resolution Computed Tomography (HRCT) scan features compatible with Usual Interstitial Pneumonia (UIP) or fibrotic Non\-Specific Interstitial Pneumonia (NSIP). The following criteria adapted from the American Thoracic Society/European Respiratory Society (ATS/ERS) consensus statement will be used for the diagnosis of the clinical manifestation of UIP (idiopathic pulmonary fibrosis):
•4\.1\. Major criteria (all present):
•4\.1\.1\. Exclusion of other known causes of interstitial lung disease, such as drug toxicities, environmental exposures, and collagen vascular diseases
•4\.1\.2\. Abnormal pulmonary function studies that include evidence of restriction with or without impaired gas exchange
•4\.1\.3\. Bibasal reticular abnormalities with minimal ground glass opacities on HRCT

•1\. A secondary cause for pulmonary fibrosis including a diagnosis of asbestosis, drug induced pulmonary fibrosis, collagen vascular disease or other secondary pulmonary fibrosis
•2\. A recognised significant co\-existing respiratory disorder
•3\. Long\-term oxygen therapy
•4\. Receiving anti\-oxidant therapy including acetylcysteine within the last 6 weeks
•5\. A respiratory tract infection within the last 2 months
•6\. Overt and persistent heart failure, a myocardial infarction within 3 years, ischaemic heart disease requiring more than one regular therapy or a clinically significant uncontrolled arrhythmia (including Mobitz type II or third degree heart block)
•7\. Significant medical, surgical or psychiatric disease that in the opinion of the patients' attending physician would affect subject safety or influence the study outcome
•8\. Women who are pregnant or breast\-feeding
•9\. Patients receiving immunosuppressant medication (with the exception of prednisolone and azathioprine according to guidelines)
•10\. Co\-trimoxazole allergy or intolerance and patients receiving medication known to interact with co\-trimoxazole