First study to test the validity of the treatment of the disease called idiopathic pulmonary fibrosis, which causes inflammation and fibrosis (scarring) of the lung tissue, with a drug called cotrimoxazole.

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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-005409-38-ES

Enrollment

Registered

2013-01-29

Start date

2013-04-19

Completion date

Unknown

Last updated

2017-12-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ambulatory patients, men and women, with well-established diagnosis of idiopathic pulmonary fibrosis. MedDRA version: 14.1 Level: PT Classification code 10021240 Term: Idiopathic pulmonary fibrosis System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders

Interventions

Trade Name: SEPTRIN Pharmaceutical Form: Tablet INN or Proposed INN: TRIMETHOPRIM Other descriptive name: TRIMETHOPRIM Concentration unit: mg milligram(s) Concentration type: equal Concentration numbe

Eligibility

Sex/Gender

All

Inclusion 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: 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

Exclusion criteria

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. 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.

Design outcomes

Primary

Measure	Time frame
Main Objective: Evaluate the efficacy of oral cotrimoxazole versus placebo in idiopathic pulmonary fibrosis (IPF).;Secondary Objective: 1. Evaluate the safety of oral cotrimoxazole versus placebo in IPF. 2. Evaluate the effect of cotrimoxazole on the natural history of Pneumocystis colonization in patients with IPF. 3. Identify the effects of cotrimoxazole systemic level of inflammatory activity in patients with IPF.;Primary end point(s): Decline in FVC of the theoretical value ? 5% at 24 weeks and / or hospitalization for respiratory causes.;Timepoint(s) of evaluation of this end point: 24 weeks	—

Measure

Time frame

Main Objective: Evaluate the efficacy of oral cotrimoxazole versus placebo in idiopathic pulmonary fibrosis (IPF).;Secondary Objective: 1. Evaluate the safety of oral cotrimoxazole versus placebo in IPF. 2. Evaluate the effect of cotrimoxazole on the natural history of Pneumocystis colonization in patients with IPF. 3. Identify the effects of cotrimoxazole systemic level of inflammatory activity in patients with IPF.;Primary end point(s): Decline in FVC of the theoretical value ? 5% at 24 weeks and / or hospitalization for respiratory causes.;Timepoint(s) of evaluation of this end point: 24 weeks

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Secondary

Measure	Time frame
Secondary end point(s): - FVC categorized (scale with 5 layers) - Decreased DLco 10% - Acute exacerbation of IPF - Scales of dyspnea - Time to progression - Any cause of hospitalization - Overall mortality - Quality of life - Distance traveled in the 6-minute test run - Reduction ? 50% at 24 weeks in the values ??of different proinflammatory cytokines - Reduction ? 50% at 24 weeks in the values ??of surfactant proteins A and / or D - Reduction ? 50% at 24 weeks in the values ??of CCL-18. - Incidence and severity of adverse events.;Timepoint(s) of evaluation of this end point: Baseline, weeks 2, 4, 6, 12, 18, 24 and 28	—

Measure

Time frame

Secondary end point(s): - FVC categorized (scale with 5 layers) - Decreased DLco 10% - Acute exacerbation of IPF - Scales of dyspnea - Time to progression - Any cause of hospitalization - Overall mortality - Quality of life - Distance traveled in the 6-minute test run - Reduction ? 50% at 24 weeks in the values ??of different proinflammatory cytokines - Reduction ? 50% at 24 weeks in the values ??of surfactant proteins A and / or D - Reduction ? 50% at 24 weeks in the values ??of CCL-18. - Incidence and severity of adverse events.;Timepoint(s) of evaluation of this end point: Baseline, weeks 2, 4, 6, 12, 18, 24 and 28

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Countries

Spain

Contacts

Public ContactClara Rosso

UICEC-H. U. Virgen del Rocío

fernando.perez.exts@juntadeandalucia.es0034955013414

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026