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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: EUCTR
Last refreshed on: 11 December 2017
Main ID:  EUCTR2012-005409-38-ES
Date of registration: 29/01/2013
Prospective Registration: Yes
Primary sponsor: Fundación Pública Andaluza para la Gestión de la Investigación en Salud de Sevilla (FISEVI)
Public title: First study to test the validity of the treatment of the disease called idiopathic pulmonary fibrosis, which causes inflammation and fibrosis (scarring) of the lung tissue, with a drug called cotrimoxazole.
Scientific title: Pilot study phase III to evaluate the efficacy and safety of Trimethoprim-sulfamethoxazole in the treatment of idiopathic pulmonary fibrosis
Date of first enrolment: 19/04/2013
Target sample size: 56
Recruitment status: Not Recruiting
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2012-005409-38
Study type:  Interventional clinical trial of medicinal product
Study design:  Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 2  
Phase:  Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no
Countries of recruitment
Spain
Contacts
Name: Clara Rosso   
Address:  Avda. Manuel Siurot 41013 Seville Spain
Telephone: 0034955013414
Email: fernando.perez.exts@juntadeandalucia.es
Affiliation:  UICEC-H. U. Virgen del Rocío
Name: Clara Rosso   
Address:  Avda. Manuel Siurot 41013 Seville Spain
Telephone: 0034955013414
Email: fernando.perez.exts@juntadeandalucia.es
Affiliation:  UICEC-H. U. Virgen del Rocío
Key inclusion & exclusion criteria
Inclusion criteria:
1. Patient, regardless of gender, aged 18 to 80 years.
2. Well-established diagnostic criteria of the FPI as ATA / ERS / JRS / ALAT 2011.
3. Ability to obtain a sample of sputum or oropharyngeal washing.
4. Forced Vital Capacity (FVC) above 50% from the theoretical value expected.
5. Distance traveled in the 6-minute test above 150 meters.
6. Normal serum levels of glucose-6-phosphate dehydrogenase.
7. Normal serum levels of vitamin B12.
8. Patient compliance or legal guardian to participate in this study by signing the informed consent.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range 11
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 45

Exclusion criteria:
1. Allergy / hypersensitivity or known gastrointestinal intolerance to cotrimoxazole
2. Use of immunosuppressants or corticosteroids in the previous 90 days at baseline.
3. Exacerbation of IPF and / or pneumonia in the 90 days prior to baseline.
4. Diagnosis confirmed or suspected neoplasia.
5. Diagnosis of liver cirrhosis or chronic hepatitis.
6. Presence of autoimmune diseases or asthma.
7. Presence of HIV infection
8. 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.
9. Pregnant or lactating or of childbearing potential not using medically approved contraceptive methods at least three months before or during trial.
10. Participation in another trial with an investigational drug within 30 days or six half-lives (the larger of the two) above the baseline.
11. Inability to follow the patient.
12. Elevated liver function tests (ALT, AST or total bilirubin> 2 x upper limit of normal).
13. Creatinine clearance <30 ml / min.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
Health Condition(s) or Problem(s) studied
Ambulatory patients, men and women, with well-established diagnosis of idiopathic pulmonary fibrosis.
MedDRA version: 14.1 Level: PT Classification code 10021240 Term: Idiopathic pulmonary fibrosis System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Therapeutic area: Diseases [C] - Parasitic Diseases [C03]
Intervention(s)

Trade Name: SEPTRIN
Pharmaceutical Form: Tablet
INN or Proposed INN: TRIMETHOPRIM
Other descriptive name: TRIMETHOPRIM
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 80-
INN or Proposed INN: SULFAMETHOXAZOLE
CAS Number: 723-46-6
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 400-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use

Primary Outcome(s)
Main Objective: Evaluate the efficacy of oral cotrimoxazole versus placebo in idiopathic pulmonary fibrosis (IPF).
Primary end point(s): Decline in FVC of the theoretical value ? 5% at 24 weeks and / or hospitalization for respiratory causes.
Secondary Objective: 1. Evaluate the safety of oral cotrimoxazole versus placebo in IPF.
2. Evaluate the effect of cotrimoxazole on the natural history of Pneumocystis colonization in patients with IPF.
3. Identify the effects of cotrimoxazole systemic level of inflammatory activity in patients with IPF.
Timepoint(s) of evaluation of this end point: 24 weeks
Secondary Outcome(s)
Secondary end point(s): - FVC categorized (scale with 5 layers)
- Decreased DLco 10%
- Acute exacerbation of IPF
- Scales of dyspnea
- Time to progression
- Any cause of hospitalization
- Overall mortality
- Quality of life
- Distance traveled in the 6-minute test run
- Reduction ? 50% at 24 weeks in the values ??of different proinflammatory cytokines
- Reduction ? 50% at 24 weeks in the values ??of surfactant proteins A and / or D
- Reduction ? 50% at 24 weeks in the values ??of CCL-18.
- Incidence and severity of adverse events.
Timepoint(s) of evaluation of this end point: Baseline, weeks 2, 4, 6, 12, 18, 24 and 28
Secondary ID(s)
TriSulfa-FPI-1
Source(s) of Monetary Support
Junta de Andalucia
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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