Idiopathic Pulmonary FibrosisPhase 3TriSulfa-FPINCT01777737
Study to Test the Validity of the Treatment of Idiopathic Pulmonary Fibrosis With Cotrimoxazole
A Phase 3 study testing Cotrimoxazole in people with Idiopathic Pulmonary Fibrosis, run by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Idiopathic Pulmonary Fibrosis
- What is being tested?
- Cotrimoxazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 3 participants
- Where
- 1 siteSpain
- Study dates
- 25 Nov 2013to 5 Nov 2015
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Hospital Universitario Virgen del Rocío/ Instituto de Biomedicina de Sevilla
Seville, 41013
About this study
Official title: Pilot Study Phase III to Evaluate the Efficacy and Safety of Trimethoprim-sulfamethoxazole in the Treatment of Idiopathic Pulmonary Fibrosis
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.
Read the 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.
- Conditions
- Idiopathic Pulmonary Fibrosis
- Being tested
- Cotrimoxazole, Placebo
- Keywords
- Idiopathic Pulmonary Fibrosis, Trimethoprim-sulfamethoxazole, Pneumocystis jiroveci
- Medical subject headings
- Idiopathic Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CotrimoxazoleDrug
24 weeks of treatment
PlaceboDrug
Also called Placebo with identical physical appearance
Identical capsules to cotrimoxazole
| Study group | Role | What they receive |
|---|---|---|
| Cotrimoxazole | Experimental | Sulfamethoxazole 400 mg. + trimethoprim 80 mg. weight-adjusted Receives: Drug: Cotrimoxazole |
| Placebo | Placebo comparator | Identical capsules to cotrimoxazole Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 weeks
Secondary outcomes (3)
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.
Measured: At 24 weeks
Evaluate the effect of cotrimoxazole on the natural history of Pneumocystis colonization in patients with IPF.
- Molecular diagnosis of colonization by Pneumocystis jiroveci.
Measured: 24 weeks
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.
Measured: At 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2013 (estimated)
- Study start25 Nov 2013
- Primary completion5 Nov 2015
- Study completion5 Nov 2015
Why it stopped: Changes in standards of care
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Pulmonary FibrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
- Sponsor type
- University, hospital or other
- Collaborators
- Junta de Andalucia
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01777737
- Sponsor's protocol ID
- TriSulfa-FPI-1
- Acronym
- TriSulfa-FPI
- Status last verified
- Nov 2017
- First submitted
- 25 Jan 2013
- Last updated
- 14 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study Phase III to Evaluate the Efficacy and Safety of Trimethoprim-sulfamethoxazole in the Treatment of Idiopathic Pulmonary Fibrosis
- ClinicalTrials.gov ID
- NCT01777737
- Acronym / sponsor ID
- TriSulfa-FPI / TriSulfa-FPI-1
- Conditions
- Idiopathic Pulmonary Fibrosis
- Keywords
- Idiopathic Pulmonary Fibrosis, Trimethoprim-sulfamethoxazole, Pneumocystis jiroveci
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Changes in standards of care
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Fundación Pública Andaluza para la gestión de la Investigación en SevillaUniversity, hospital or other
- Collaborators
- Junta de Andalucia
- Study start
- 25 Nov 2013 (actual)
- Primary completion
- 5 Nov 2015 (actual)
- Study completion
- 5 Nov 2015 (actual)
- First posted
- 29 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cotrimoxazole | Experimental | Drug: CotrimoxazoleSulfamethoxazole 400 mg. + trimethoprim 80 mg. weight-adjusted |
| Placebo | Placebo comparator | Drug: PlaceboIdentical capsules to cotrimoxazole |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cotrimoxazole24 weeks of treatment | Drug | Cotrimoxazole |
| PlaceboAlso: Placebo with identical physical appearanceIdentical capsules to cotrimoxazole | Drug | Placebo |
Primary outcome
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.
3 secondary outcomes
Evaluate the safety of oral cotrimoxazole versus placebo in IPF.
Time frame: At 24 weeks
Evaluate the effect of cotrimoxazole on the natural history of Pneumocystis colonization in patients with IPF.
Time frame: 24 weeks
Identify the effects of cotrimoxazole systemic level of inflammatory activity in patients with IPF.
Time frame: At 24 weeks
Results and safety
The study was stopped early (reason given: Changes in standards of care). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Cotrimoxazole in people with Idiopathic Pulmonary Fibrosis, run by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 14 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Changes in standards of care). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the efficacy of oral cotrimoxazole versus placebo in idiopathic pulmonary fibrosis (IPF). (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2017.