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

Primary Purpose

Idiopathic Pulmonary Fibrosis

Status
Terminated
Phase
Phase 3
Locations
Spain
Study Type
Interventional
Intervention
Cotrimoxazole
Placebo
Sponsored by
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Idiopathic Pulmonary Fibrosis focused on measuring Idiopathic Pulmonary Fibrosis, Trimethoprim-sulfamethoxazole, Pneumocystis jiroveci

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hospital Universitario Virgen del Rocío/ Instituto de Biomedicina de Sevilla

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Cotrimoxazole

Placebo

Arm Description

Sulfamethoxazole 400 mg. + trimethoprim 80 mg. weight-adjusted

Identical capsules to cotrimoxazole

Outcomes

Primary Outcome Measures

Evaluate the efficacy of oral cotrimoxazole versus placebo in idiopathic pulmonary fibrosis (IPF).
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 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.
- Molecular diagnosis of colonization by Pneumocystis jiroveci.
Identify the effects of cotrimoxazole systemic level of inflammatory activity in patients with IPF.
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.

Full Information

First Posted
January 25, 2013
Last Updated
November 13, 2017
Sponsor
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Collaborators
Junta de Andalucia
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1. Study Identification

Unique Protocol Identification Number
NCT01777737
Brief Title
Study to Test the Validity of the Treatment of Idiopathic Pulmonary Fibrosis With Cotrimoxazole
Acronym
TriSulfa-FPI
Official Title
Pilot Study Phase III to Evaluate the Efficacy and Safety of Trimethoprim-sulfamethoxazole in the Treatment of Idiopathic Pulmonary Fibrosis
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Terminated
Why Stopped
Changes in standards of care
Study Start Date
November 25, 2013 (Actual)
Primary Completion Date
November 5, 2015 (Actual)
Study Completion Date
November 5, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Collaborators
Junta de Andalucia

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Idiopathic Pulmonary Fibrosis
Keywords
Idiopathic Pulmonary Fibrosis, Trimethoprim-sulfamethoxazole, Pneumocystis jiroveci

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
3 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cotrimoxazole
Arm Type
Experimental
Arm Description
Sulfamethoxazole 400 mg. + trimethoprim 80 mg. weight-adjusted
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Identical capsules to cotrimoxazole
Intervention Type
Drug
Intervention Name(s)
Cotrimoxazole
Intervention Description
24 weeks of treatment
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Placebo with identical physical appearance
Intervention Description
Identical capsules to cotrimoxazole
Primary Outcome Measure Information:
Title
Evaluate the efficacy of oral cotrimoxazole versus placebo in idiopathic pulmonary fibrosis (IPF).
Description
Decline of the FVC ≥ 5% at 24 weeks and / or hospitalization for respiratory causes.
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Evaluate the safety of oral cotrimoxazole versus placebo in IPF.
Description
Time to progression Any cause of hospitalization Overall mortality Incidence and severity of adverse events.
Time Frame
At 24 weeks
Title
Evaluate the effect of cotrimoxazole on the natural history of Pneumocystis colonization in patients with IPF.
Description
- Molecular diagnosis of colonization by Pneumocystis jiroveci.
Time Frame
24 weeks
Title
Identify the effects of cotrimoxazole systemic level of inflammatory activity in patients with IPF.
Description
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.
Time Frame
At 24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Hospital Universitario Virgen del Rocío/ Instituto de Biomedicina de Sevilla
City
Sevilla
ZIP/Postal Code
41013
Country
Spain

12. IPD Sharing Statement

Learn more about this trial

Study to Test the Validity of the Treatment of Idiopathic Pulmonary Fibrosis With Cotrimoxazole

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