EUCTR2012-005409-38-ES
Active, not recruiting
Phase 1
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 sites56 target enrollmentJanuary 29, 2013
ConditionsAmbulatory patients, men and women, with well-established diagnosis of idiopathic pulmonary fibrosis.MedDRA version: 14.1Level: PTClassification code 10021240Term: Idiopathic pulmonary fibrosisSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersTherapeutic area: Diseases [C] - Parasitic Diseases [C03]
DrugsSEPTRIN
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Ambulatory patients, men and women, with well-established diagnosis of idiopathic pulmonary fibrosis.
- Sponsor
- Fundación Pública Andaluza para la Gestión de la Investigación en Salud de Sevilla (FISEVI)
- Enrollment
- 56
- Status
- Active, not recruiting
- Last Updated
- 8 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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:
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Not specified
Similar Trials
Completed
Not Applicable
euprolide acetate 3 month depot medicine use in advance prostate cancerHealth Condition 1: C61- Malignant neoplasm of prostateCTRI/2021/07/034710Bharat Serums and Vaccines ltd8
Active, not recruiting
Not Applicable
A phase III trial investigating the efficacy and safety of Grazax in children aged 5-16 years with grass pollen induced rhinoconjunctivitis with or without asthmaIgE Mediated allergy (hay fever, rhinoconjunctivitis) to grass pollen (Timothy grass, Phleum pratense) with or without asthmaEUCTR2006-003415-46-DEALK-Abello, Group Clinical Development
Completed
Phase 3
A Phase 3 study to evaluate the efficacy and safety of docetaxel and prednisone with or without lenalidomide in subjects with castrate-resistant prostate cancer.prostate cancer that can't be treated surgically1003859710036958NL-OMON43687Celgene Corporation136
Active, not recruiting
Phase 1
Efficacy and safety of delgocitinib cream in adolescents 12-17 years of age with moderate to severe chronic hand eczemaEUCTR2021-006340-27-BEEO Pharma A/S92
Active, not recruiting
Phase 1
Efficacy and safety of delgocitinib cream in adolescents 12-17 years of age with moderate to severe chronic hand eczemaEUCTR2021-006340-27-FREO Pharma A/S92