Study to Test the Validity of the Treatment of Idiopathic Pulmonary Fibrosis With Cotrimoxazole (TriSulfa-FPI)

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Sponsor:
Collaborator:
Junta de Andalucia
Information provided by (Responsible Party):
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
ClinicalTrials.gov Identifier:
NCT01777737
First received: January 25, 2013
Last updated: August 5, 2014
Last verified: August 2014
  Purpose

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 Intervention Phase
Idiopathic Pulmonary Fibrosis
Drug: Cotrimoxazole
Drug: Placebo
Phase 3

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 56
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)
Arms Assigned Interventions
Experimental: Cotrimoxazole
Sulfamethoxazole 400 mg. + trimethoprim 80 mg. weight-adjusted
Drug: Cotrimoxazole
24 weeks of treatment
Placebo Comparator: Placebo
Identical capsules to cotrimoxazole
Drug: Placebo
Identical capsules to cotrimoxazole
Other Name: Placebo with identical physical appearance

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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01777737

Contacts
Contact: Francisco J. Medrano Ortega, PhD medrano@cica.es
Contact: Fernando Pérez Martínez, PhD 955013414 fernando.perez.exts@juntadeandalucia.es

Locations
Spain
Hospital Universitario Virgen del Rocío/ Instituto de Biomedicina de Sevilla Recruiting
Sevilla, Spain, 41013
Principal Investigator: Francisco J Medrano Ortega, PhD         
Sponsors and Collaborators
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Junta de Andalucia
  More Information

No publications provided

Responsible Party: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
ClinicalTrials.gov Identifier: NCT01777737     History of Changes
Other Study ID Numbers: TriSulfa-FPI-1
Study First Received: January 25, 2013
Last Updated: August 5, 2014
Health Authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios

Keywords provided by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla:
Idiopathic Pulmonary Fibrosis
Trimethoprim-sulfamethoxazole
Pneumocystis jiroveci

Additional relevant MeSH terms:
Fibrosis
Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Idiopathic Interstitial Pneumonias
Lung Diseases, Interstitial
Sulfamethoxazole
Trimethoprim
Trimethoprim-Sulfamethoxazole Combination
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Infective Agents, Urinary
Renal Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Folic Acid Antagonists
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 27, 2014