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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT01777737 |
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Date of registration:
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25/01/2013 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Study to Test the Validity of the Treatment of Idiopathic Pulmonary Fibrosis With Cotrimoxazole
TriSulfa-FPI |
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Scientific title:
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Pilot Study Phase III to Evaluate the Efficacy and Safety of Trimethoprim-sulfamethoxazole in the Treatment of Idiopathic Pulmonary Fibrosis |
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Date of first enrolment:
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November 25, 2013 |
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Target sample size:
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3 |
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Recruitment status: |
Terminated |
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URL:
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https://clinicaltrials.gov/show/NCT01777737 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator).
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Phase:
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Phase 3
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Countries of recruitment
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Spain
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Patient, regardless of gender, aged 18 to 80 years.
- Well-established diagnostic criteria of the Idiopathic Pulmonary Fibrosis (IPF) as
ATA/ERS/JRS/ALAT 2011.
- Ability to obtain a sample of sputum or oropharyngeal washing.
- Forced Vital Capacity (FVC) above 50% from the theoretical value expected.
- Patient compliance or legal guardian to participate in this study by signing the
informed consent.
Exclusion Criteria:
- Allergy / hypersensitivity or known gastrointestinal intolerance to cotrimoxazole.
- Use of immunosuppressants or corticosteroids in the previous 90 days at baseline.
- Exacerbation of IPF and / or pneumonia in the 90 days prior to baseline.
- Presence of autoimmune diseases or asthma.
- 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.
- Pregnant or lactating or of childbearing potential not using medically approved
contraceptive methods at least three months before or during trial.
- Participation in another trial with an investigational drug within 30 days or six
half-lives (the larger of the two) above the baseline.
Age minimum:
18 Years
Age maximum:
80 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Idiopathic Pulmonary Fibrosis
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Intervention(s)
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Drug: Cotrimoxazole
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Drug: Placebo
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Primary Outcome(s)
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Evaluate the efficacy of oral cotrimoxazole versus placebo in idiopathic pulmonary fibrosis (IPF).
[Time Frame: 24 weeks]
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Secondary Outcome(s)
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Evaluate the effect of cotrimoxazole on the natural history of Pneumocystis colonization in patients with IPF.
[Time Frame: 24 weeks]
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Identify the effects of cotrimoxazole systemic level of inflammatory activity in patients with IPF.
[Time Frame: At 24 weeks]
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Evaluate the safety of oral cotrimoxazole versus placebo in IPF.
[Time Frame: At 24 weeks]
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Secondary ID(s)
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TriSulfa-FPI-1
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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