Study to Test the Validity of the Treatment of Idiopathic Pulmonary Fibrosis With Cotrimoxazole
Information source: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Idiopathic Pulmonary Fibrosis
Intervention: Cotrimoxazole (Drug); Placebo (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla Overall contact:
Francisco J. Medrano Ortega, PhD, Email: medrano@cica.es
Summary
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.
Clinical Details
Official title: Pilot Study Phase III to Evaluate the Efficacy and Safety of Trimethoprim-sulfamethoxazole in the Treatment of 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
Primary outcome: Evaluate the efficacy of oral cotrimoxazole versus placebo in idiopathic pulmonary fibrosis (IPF).
Secondary outcome: Evaluate the safety of oral cotrimoxazole versus placebo in IPF.Evaluate the effect of cotrimoxazole on the natural history of Pneumocystis colonization in patients with IPF. Identify the effects of cotrimoxazole systemic level of inflammatory activity in patients with IPF.
Detailed description:
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 80 Years.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Francisco J. Medrano Ortega, PhD, Email: medrano@cica.es
Hospital Universitario Virgen del RocÃo/ Instituto de Biomedicina de Sevilla, Sevilla 41013, Spain; Recruiting
Francisco J Medrano Ortega, PhD, Principal Investigator
Additional Information
Starting date: June 2013
Last updated: March 17, 2015
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