Study to Test the Validity of the Treatment of Idiopathic Pulmonary Fibrosis With Cotrimoxazole (TriSulfa-FPI)
|ClinicalTrials.gov Identifier: NCT01777737|
Recruitment Status : Terminated (Changes in standards of care)
First Posted : January 29, 2013
Last Update Posted : November 14, 2017
First study to test the validity of the treatment of idiopathic pulmonary fibrosis, which causes inflammation and fibrosis (scarring) of the lung tissue, with cotrimoxazole.
Cotrimoxazole may improve the clinical course of the disease through eradication of Pneumocystis jiroveci colonization and other mechanisms as inhibiting the activation of alveolar macrophages and producing alterations in the surfactant system which favours the persistent activation of the inflammatory response and the development of pulmonary fibrosis.
|Condition or disease||Intervention/treatment||Phase|
|Idiopathic Pulmonary Fibrosis||Drug: Cotrimoxazole Drug: Placebo||Phase 3|
Idiopathic pulmonary fibrosis (IPF) is a chronic lung disease that is clinically manifested by the appearance of effort dyspnea and impaired lung function.
The natural history of the disease is poorly understood and there is no clear consensus as to the most appropriate markers for predicting patient outcome.
This pilot controlled trial aims to test the efficacy and safety of cotrimoxazole in the treatment of IPF. This novel therapeutic strategy, with very encouraging preliminary data is based on its pathophysiological basis, primarily related to the elimination of Pneumocystis colonization. That elimination, could serve as a potent weapon for reducing morbidity and mortality and the cost associated with this devastating disease.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||3 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Pilot Study Phase III to Evaluate the Efficacy and Safety of Trimethoprim-sulfamethoxazole in the Treatment of Idiopathic Pulmonary Fibrosis|
|Actual Study Start Date :||November 25, 2013|
|Actual Primary Completion Date :||November 5, 2015|
|Actual Study Completion Date :||November 5, 2015|
Sulfamethoxazole 400 mg. + trimethoprim 80 mg. weight-adjusted
24 weeks of treatment
Placebo Comparator: Placebo
Identical capsules to cotrimoxazole
Identical capsules to cotrimoxazole
Other Name: Placebo with identical physical appearance
- Evaluate the efficacy of oral cotrimoxazole versus placebo in idiopathic pulmonary fibrosis (IPF). [ Time Frame: 24 weeks ]Decline of the FVC ≥ 5% at 24 weeks and / or hospitalization for respiratory causes.
- Evaluate the safety of oral cotrimoxazole versus placebo in IPF. [ Time Frame: At 24 weeks ]
- Time to progression
- Any cause of hospitalization
- Overall mortality
- Incidence and severity of adverse events.
- Evaluate the effect of cotrimoxazole on the natural history of Pneumocystis colonization in patients with IPF. [ Time Frame: 24 weeks ]- Molecular diagnosis of colonization by Pneumocystis jiroveci.
- Identify the effects of cotrimoxazole systemic level of inflammatory activity in patients with IPF. [ Time Frame: At 24 weeks ]
- Acute exacerbation of IPF
- Scales of dyspnea
- Reduction > 50% in the values of different proinflammatory cytokines
- Reduction > 50% in the values of surfactant proteins.
- Reduction > 50% in the values of chemokine CCL-18.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01777737
|Hospital Universitario Virgen del Rocío/ Instituto de Biomedicina de Sevilla|
|Sevilla, Spain, 41013|