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

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ClinicalTrials.gov Identifier: NCT01777737
Recruitment Status : Terminated (Changes in standards of care)
First Posted : January 29, 2013
Last Update Posted : November 14, 2017
Junta de Andalucia
Information provided by (Responsible Party):
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

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.

Condition or disease Intervention/treatment Phase
Idiopathic Pulmonary Fibrosis Drug: Cotrimoxazole Drug: Placebo Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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
Actual Study Start Date : November 25, 2013
Actual Primary Completion Date : November 5, 2015
Actual Study Completion Date : November 5, 2015

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01777737

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Hospital Universitario Virgen del Rocío/ Instituto de Biomedicina de Sevilla
Sevilla, Spain, 41013
Sponsors and Collaborators
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Junta de Andalucia
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Responsible Party: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
ClinicalTrials.gov Identifier: NCT01777737    
Other Study ID Numbers: TriSulfa-FPI-1
First Posted: January 29, 2013    Key Record Dates
Last Update Posted: November 14, 2017
Last Verified: November 2017
Keywords provided by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla:
Idiopathic Pulmonary Fibrosis
Pneumocystis jiroveci
Additional relevant MeSH terms:
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Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Trimethoprim, Sulfamethoxazole Drug Combination
Anti-Infective Agents, Urinary
Anti-Infective Agents
Renal Agents
Anti-Bacterial Agents
Antiprotozoal Agents
Antiparasitic Agents