Pilot study phase III to evaluate the efficacy and safety of Trimethoprim-sulfamethoxazole in the treatment of idiopathic pulmonary fibrosis

Fundación Pública Andaluza para la Gestión de la Investigación en Salud de Sevilla (FISEVI)0 个研究点目标入组 56 人开始时间: 2013年1月29日最近更新: 2017年12月11日

适应症

试验速览

暂无简介。

•1. Patient, regardless of gender, aged 18 to 80 years.
•2. Well-established diagnostic criteria of the FPI as ATA / ERS / JRS / ALAT 2011.
•3. Ability to obtain a sample of sputum or oropharyngeal washing.
•4. Forced Vital Capacity (FVC) above 50% from the theoretical value expected.
•5. Distance traveled in the 6-minute test above 150 meters.
•6. Normal serum levels of glucose-6-phosphate dehydrogenase.
•7. Normal serum levels of vitamin B12.
•8. Patient compliance or legal guardian to participate in this study by signing the informed consent.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) no
•F.1.2.1 Number of subjects for this age range 11
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 45

•1. Allergy / hypersensitivity or known gastrointestinal intolerance to cotrimoxazole
•2. Use of immunosuppressants or corticosteroids in the previous 90 days at baseline.
•3. Exacerbation of IPF and / or pneumonia in the 90 days prior to baseline.
•4. Diagnosis confirmed or suspected neoplasia.
•5. Diagnosis of liver cirrhosis or chronic hepatitis.
•6. Presence of autoimmune diseases or asthma.
•7. Presence of HIV infection
•8. Patients with other significant diseases other than IPF. It is considered significant disease any disease or condition that, in the investigator's opinion, may jeopardize the patient's health participating in the study or influence the results of the study or the patient's ability to participate in the study.
•9. Pregnant or lactating or of childbearing potential not using medically approved contraceptive methods at least three months before or during trial.
•10. Participation in another trial with an investigational drug within 30 days or six half-lives (the larger of the two) above the baseline.
•11. Inability to follow the patient.
•12. Elevated liver function tests (ALT, AST or total bilirubin> 2 x upper limit of normal).
•13. Creatinine clearance <30 ml / min.

发起方

Fundación Pública Andaluza para la Gestión de la Investigación en Salud de Sevilla (FISEVI)