Study to Test the Validity of the Treatment of Idiopathic Pulmonary Fibrosis With Cotrimoxazole (TriSulfa-FPI)
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.
Idiopathic Pulmonary Fibrosis
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
|Official Title:||Pilot Study Phase III to Evaluate the Efficacy and Safety of Trimethoprim-sulfamethoxazole in the Treatment of Idiopathic Pulmonary Fibrosis|
- Evaluate the efficacy of oral cotrimoxazole versus placebo in idiopathic pulmonary fibrosis (IPF). [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: Yes ]
- 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 ] [ Designated as safety issue: No ]- 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 ] [ Designated as safety issue: Yes ]
- 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.
|Study Start Date:||June 2013|
|Estimated Study Completion Date:||December 2014|
|Estimated Primary Completion Date:||September 2014 (Final data collection date for primary outcome measure)|
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
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.
|Contact: Francisco J. Medrano Ortega, PhDfirstname.lastname@example.org|
|Contact: Fernando Pérez Martínez, PhDemail@example.com|
|Hospital Universitario Virgen del Rocío/ Instituto de Biomedicina de Sevilla||Recruiting|
|Sevilla, Spain, 41013|
|Principal Investigator: Francisco J Medrano Ortega, PhD|