The Efficacy and Mechanism Evaluation of Treating Idiopathic Pulmonary fibrosis with the Addition of Co-trimoxazole (EME-TIPAC)

orfolk and Norwich University Hospital NHS Trust0 sites342 target enrollmentJanuary 29, 2015

Overview

Phase: 未知
Intervention: Not specified
Conditions: Not specified
Sponsor: orfolk and Norwich University Hospital NHS Trust
Enrollment: 342
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

2018 protocol in https://www.ncbi.nlm.nih.gov/pubmed/29402332 2020 results in https://pubmed.ncbi.nlm.nih.gov/33289822/ (added 10/12/2020)

Registry

who.int

Start Date

January 29, 2015

End Date

May 31, 2019

Last Updated

5 years ago

Study Type

Interventional

Sex

All

Investigators

Sponsor

orfolk and Norwich University Hospital NHS Trust

Eligibility Criteria

Inclusion Criteria

•Inclusion criteria as of 21/11/2016:
•1\. Male or female, aged greater than or equal to 40 years. IPF rarely occurs in individuals less than 40 years. Individuals younger than this more frequently have connective tissue related lung disease which is similar to but different from IPF.
•2\. A diagnosis of idiopathic pulmonary fibrosis (IPF) based on multi\-disciplinary consensus according to the latest international guidelines.
•3\. Patients may receive oral prednisolone up to a dose of 10 mg per day, anti\-oxidant therapy, pirfenidone or other licensed medication for IPF e.g. nintedanib. Patients should be on a stable treatment regimen for at least 4 weeks to ensure baseline values are representative.
•4\. MRC dyspnoea score of greater than 1\.
•5\. Able to provide informed consent.; Target Gender: Male \& Female ; Lower Age Limit 40 years
•Original inclusion criteria:
•1\. Male or female, aged greater than or equal to 40 years. IPF rarely occurs in individuals less than 40 years. Individuals younger than this more frequently have connective tissue related lung disease which is similar to but different from IPF.
•2\. A diagnosis of idiopathic pulmonary fibrosis (IPF) based on multi\-disciplinary consensus according to the latest international guidelines within 2 years of enrollment into the study. Patients with a diagnosis of more than 2 years duration can be enrolled if they have evidence of progressive disease defined as \=10% decline in forced vital capacity (FVC) or \=15% decline in diffusing capacity of carbon monoxide over the preceding 6 or 12 months.
•3\. Patients may receive oral prednisolone up to a dose of 10 mg per day, anti\-oxidant therapy, pirfenidone or other licensed medication for IPF e.g. nintedanib. Patients should be on a stable treatment regimen for at least 6 weeks to ensure baseline values are representative.

Exclusion Criteria

•Exclusion criteria as of 21/11/2016:
•1\. FVC \> 75% predicted.
•2\. A recognised significant co\-existing respiratory disease, defined as a respiratory condition that exhibits a greater clinical effect on respiratory symptoms and disease progression than IPF as determined by the principal investigator.
•3\. Patients with airways disease defined as forced expiratory volume in 1 second (FEV1\)/FVC\<60%
•4\. A self\-reported respiratory tract infection within 4 weeks of screening defined as two or more of cough, sputum or breathlessness and requiring antimicrobial therapy.
•5\. Significant medical, surgical or psychiatric disease that in the opinion of the patient’s attending physician would affect subject safety or influence the study outcome including liver (Serum transaminase \> 3 x upper limit of normal (ULN), Bilirubin \> 2 x ULN) and renal failure (creatinine clearance \<30ml/min).
•6\. Patients receiving recognised immunosuppressant medication (except prednisolone above) including azathioprine and mycophenolate mofetil.
•7\. Female subjects must be of non\-childbearing potential, defined as follows: postmenopausal females who have had at least 12 months of spontaneous amenorrhoea or 6 months of spontaneous amenorrhoea with serum FSH\>40mIU/ml or females who have had a hysterectomy or bilateral oophorectomy at least 6 weeks prior to enrolment.
•8\. Allergy or intolerance to trimethoprim or sulphonamides or their combination.
•9\. Untreated folate or B12 deficiency.