NCT01777737

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Nov 2013

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 25, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 29, 2013

Completed
10 months until next milestone

Study Start

First participant enrolled

November 25, 2013

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 5, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 5, 2015

Completed
Last Updated

November 14, 2017

Status Verified

November 1, 2017

Enrollment Period

1.9 years

First QC Date

January 25, 2013

Last Update Submit

November 13, 2017

Conditions

Idiopathic Pulmonary Fibrosis

Keywords

Idiopathic Pulmonary FibrosisTrimethoprim-sulfamethoxazolePneumocystis jiroveci

Outcome Measures

Primary Outcomes (1)

  • 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.

    24 weeks

Secondary Outcomes (3)

  • Evaluate the safety of oral cotrimoxazole versus placebo in IPF.

    At 24 weeks

  • Evaluate the effect of cotrimoxazole on the natural history of Pneumocystis colonization in patients with IPF.

    24 weeks

  • Identify the effects of cotrimoxazole systemic level of inflammatory activity in patients with IPF.

    At 24 weeks

Study Arms (2)

Cotrimoxazole

EXPERIMENTAL

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

Drug: Cotrimoxazole

Placebo

PLACEBO COMPARATOR

Identical capsules to cotrimoxazole

Drug: Placebo

Interventions

CotrimoxazoleDRUG

24 weeks of treatment

Cotrimoxazole
PlaceboDRUG

Identical capsules to cotrimoxazole

Also known as: Placebo with identical physical appearance
Placebo

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitario Virgen del Rocío/ Instituto de Biomedicina de Sevilla

Seville, 41013, Spain

Location

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis

Interventions

Trimethoprim, Sulfamethoxazole Drug Combination

Condition Hierarchy (Ancestors)

Pulmonary FibrosisLung Diseases, InterstitialLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

SulfamethoxazoleBenzenesulfonamidesSulfonamidesAmidesOrganic ChemicalsSulfanilamidesAniline CompoundsAminesBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsSulfonesSulfur CompoundsTrimethoprimPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsDrug CombinationsPharmaceutical Preparations

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 25, 2013

First Posted

January 29, 2013

Study Start

November 25, 2013

Primary Completion

November 5, 2015

Study Completion

November 5, 2015

Last Updated

November 14, 2017

Record last verified: 2017-11

Locations

ES(1)