Idiopathic Interstitial Pneumonia MedDRA version: 9.1 Level: LLT Classification code 10022619 Term: Interstitial pulmonary fibrosis
Conditions
Interventions
Trade Name: Septrin
Product Name: co-trimoxazole
Product Code: N/A
Pharmaceutical Form: Tablet
INN or Proposed INN: N/A
CAS Number: 8064902
Current Sponsor code: N/A
Other descriptive name: CO-TRIMOXA
Sponsors
University of East Anglia
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female, aged greater than 40 years 2. Female subjects must be of non-childbearing potential, defined as follows • postmenopausal females who have had at least 12 months of spontaneous amenorrhea or 6 months of spontaneous amenorrhoea with serum FSH>40mIU/ml • 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 HRCT scan features compatible with Usual Interstitial Pneumonia (UIP) or Fibrotic Non-specific Interstitial Pneumonia (NSIP). The following criteria adapted from the ATS/ERS consensus statement will be used for the diagnosis the clinical manifestation of UIP (idiopathic pulmonary fibrosis): • Major Criteria (All present) o Exclusion of other known causes of interstitial lung disease, such as drug toxicities, environmental exposures, and collagen vascular diseases o Abnormal pulmonary function studies that include evidence of restriction with or without impaired gas exchange o Bibasal reticular abnormalities with minimal ground glass opacities on HRCT • Minor criteria (two out of three features) o Insidious onset of otherwise unexplained dyspnoea on exertion o Duration of illness 3 months o Bibasal inspiratory crackles (dry or ‘‘Velcro-’’ type in quality) Patients with clinical diagnosis of non-specific interstitial pneumonia will be entered if fibrotic features are predominant on HRCT. Histology will not be required as an entry criterion. 5. Patients will have had initial treatment of prednisolone +/- azathioprine, as indicated and described in the current BTS guidelines, without a without a significant response to immunosuppressive therapy that would make the physician doubt the diagnosis of fibrotic idiopathic interstitial pneumonia. 6. Patients should be on stable treatment regimen for at least 6 weeks. This will include oral prednisolone up to a dose of 20mg per day +/- azathioprine. Patients receiving higher doses of up to 0.5mg/kg may be enrolled in exceptional circumstances after discussion with the principal investigator. 7. MRC dyspnoea score of ?2 8. A normal serum folate and B12 (to ensure no bone marrow or neurological adverse effects occur with folate therapy to B12 deficient individuals) is required at screening. 9. Subjects have a 12 lead ECG recording that does not demonstrate any clinically important abnormality that, in the opinion of the investigator, would make the subject unsuitable for participation in the study. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 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 are 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. 11. Untreated folate or B12 deficiency. 12. Known glucose-6-phosphate dehydrogenase deficiency. 13. Receipt of an investigational drug or biological agent within the 4 weeks prior to entry in to this study. 14. Patients with evidence of drug or alcohol misuse
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the efficacy and safety of 6 months therapy with co-trimoxazole 960mg twice daily when added to standard treatment/care in a placebo controlled study of patients with idiopathic interstitial pneumonia;Secondary Objective: The secondary objective is to estimate the incremental cost effectiveness of co-trimoxazole plus standard care compared with standard care alone;Primary end point(s): Change in forced vital capacity Change in 6 minute walking distance and desaturation Change in MRC breathlessness score Change in total lung capacity Change in total lung diffusing capacity of carbon monoxide Change in St Georges Respiratory Questionnaire | — |
Countries
United Kingdom
Outcome results
None listed