Alveolitis Extrinsic AllergicPhase 2/3PicheonNCT02496182
Pirfenidone in the Chronic Hypersensitivity Pneumonitis Treatment
A Phase 2/3 study testing Pirfenidone in people with Alveolitis Extrinsic Allergic and Pulmonary Fibrosis, run by Grupo Medifarma, S. A. de C. V. at 1 site in Mexico.
Trial summary
The Chronic Hypersensitivity Pneumonitis (HP), is an inflammatory disease who has an evolution to develop progressive interstitial fibrosis, who cause the death of the patient. Actually HP has been treated with Prednisone and occasionally with Azathioprine, but unfortunately the treatment with these drugs have not an… Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Alveolitis Extrinsic Allergic, Pulmonary Fibrosis
- What is being tested?
- Pirfenidone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteMexico
- Study dates
- Jul 2015to Jan 2017
- Phase
- Phase 2/3
- 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 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic Hypersensitivity pneumonitis with recent diagnosis confirmed by HRT with or without biopsy
- Acceptation with signed informed consent
Who cannot join
- No confirmed diagnosis
- Patients with peptic ulcer
- Pregnancy or breast feeding period
- Clinical signs of active infection
- History of severe Hepatic disease
- History of severe Kidney disease, who requires some kind of dialysis
Show all 13Show fewer
- History of inestable cardiopathy
- History of alcohol or drugs abuse
- Bronchial hyperactivity or History of asthma or EPOC
- Smoking habit 3 months before the starting or patient who decline suspend the smoking habit during the study
- Patient with impossibility to make spirometry or who can not walk
- Use of Immunosuppressants, cytotoxic agents, cytosine modulators or receptor antagonist, fluvoxamine or daily use of sildenafil.
- Patients who not accept sign the informed consent
Trial locations and contacts
1 site in 1 country.
Mexico1 site, 1 recruiting
- Recruiting
Instituto Nacional de Enfermedades Respiratorias
Mexico City, Mexico City, 14080
Heidegger Mateos, MD, +5255 5487 1771
Pedro Pena, MD, +5215591971972, pedropena@grupomedifarma.com
About this study
The Chronic Hypersensitivity Pneumonitis (HP), is an inflammatory disease who has an evolution to develop progressive interstitial fibrosis, who cause the death of the patient. Actually HP has been treated with Prednisone and occasionally with Azathioprine, but unfortunately the treatment with these drugs have not an effective result to treat the interstitial fibrosis.
Pirfenidone has been studied over the world for the treatment of Fibrotic diseases, with positive results, and due to the Pirfenidone mechanism of action has anti-inflammatory and anti-fibrotic properties, the investigators propose to evaluate the addition of Pirfenidone to the actual treatment with Prednisone and Azathioprine in the treatment of patients with Pulmonary Fibrosis secondary to a Chronic Hypersensitivity Pneumonitis.
Read the detailed description
The Chronic Hypersensitivity Pneumonitis (HP), is a complex syndrome due to a exaggerated immune response caused by inhalation of foreign substances, such as molds, dusts, and organic particles, causing alveoli inflammation and in the chronic forms the disease has high rate of mortality, due to the big number of patients who develop progressive interstitial fibrosis and eventually they curse with respiratory insufficiency who cause the death of the patient.
Pirfenidone has been studied over the world for the treatment of Idiophatic Pulmonary Fibrosis (IPF), disease who constitute the most aggressive of the fibrotic diseases of the lung. Additionally Pirfenidone has been showed potential results in the treatment of fibrotic diseases in other organs, as Liver, Kidney, Hearth, etc. Pirfenidone has been described as a modulator of the fibrotic process due to his action over TGF-beta and MMP´s and also has into-inflammatory actions acting over TNF-alfa and IL-1 and IL-6.
Actually HP has been treated with Prednisone and occasionally with Azathioprine, but a high number of patients will develop irreversibly to a interstitial fibrosis with pulmonary parenchyma destruction. Unfortunately the investigators have not an effective treatment for this cases. Due to the positive results obtained with Pirfenidone in the treatment of IPF and other kind of organ fibrosis, the investigators propose to evaluate the addition of Pirfenidone to the treatment with Prednisone and Azathioprine in the treatment of patients with Pulmonary Fibrosis secondary to a Chronic Hypersensitivity Pneumonitis.
- Conditions
- Alveolitis Extrinsic Allergic, Pulmonary Fibrosis
- Being tested
- Placebo, Pirfenidone
- Medical subject headings
- Alveolitis, Extrinsic Allergic, Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Also called Excipient Tablet
Placebo tablet only with the excipients of the Pirfenidone tablet
PirfenidoneDrug
Also called Kitoscell LP
Conventional Treatment (Prednisone+Azathioprine) plus Pirfenidone 1800 mg
PirfenidoneDrug
Also called KitosCell LP
Conventional Treatment (Prednisone+Azathioprine) plus Pirfenidone 1200 mg
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Conventional treatment (Prednisone 0.5 mg/kg/day for 4 weeks, then 0.25 mg/Kg/day for 8 weeks and maintenance dosage of 0.125 mg/Kg/day plus Azathioprine 2-3 mg/kg/day with a maximal dosage of 150 mg/day starting with 25-50 mg/day increasing gradually until day 14 with maximal dosage) plus Placebo tablet 2 times at day. Receives: Drug: Placebo |
| Pirfenidone 1800 mg | Experimental | Conventional treatment (0.5 mg/kg/day for 4 weeks, then 0.25 mg/Kg/day for 8 weeks and maintenance dosage of 0.125 mg/Kg/day plus Azathioprine 2-3 mg/kg/day with a maximal dosage of 150 mg/day starting with 25-50 mg/day increasing gradually until day 14 with maximal dosage) plus Pirfenidone long release tablet 900 mg 2 times at day, starting with 600 mg at day Receives: Drug: Pirfenidone |
| Pirfenidone 1200 mg | Experimental | Conventional treatment (0.5 mg/kg/day for 4 weeks, then 0.25 mg/Kg/day for 8 weeks and maintenance dosage of 0.125 mg/Kg/day plus Azathioprine 2-3 mg/kg/day with a maximal dosage of 150 mg/day starting with 25-50 mg/day increasing gradually until day 14 with maximal dosage) plus Pirfenidone long release tablet 600 mg 2 times at day starting with 600 mg at day Receives: Drug: Pirfenidone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Forced Vital Capacity (FVC)
The measurement of FVC will be at 26 and 52 weeks
Measured: 52 weeks
Secondary outcomes (5)
High Resolution Tomography
Evaluation of the inflammation and fibrosis grade with the Kazerooni scale
Measured: 52 weeks
6 minutes walk distance test
quantification of the walking distance at 6 minutes
Measured: 52 weeks
San George Qty Score, SOBQ and EQ5D Quality Scores
As a composite outcome to evaluate the quality of life
Measured: 52 weeks
Pulmonary artery systolic pressure with echocardiogram
measurement of pressure
Measured: 52 weeks
Oxygen desaturation in exercise
Measurement of Oxygen
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2015 (estimated)
- Study startJul 2015
- Primary completionJan 2016 (estimated)
- Study completionJan 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Alveolitis Extrinsic AllergicStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Grupo Medifarma, S. A. de C. V.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02496182
- Sponsor's protocol ID
- C34-11
- Acronym
- Picheon
- Status last verified
- Jul 2015
- First submitted
- 6 Jul 2015
- Last updated
- 14 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Lacasse Y, Selman M, Costabel U, Dalphin JC, Ando M, Morell F, Erkinjuntti-Pekkanen R, Muller N, Colby TV, Schuyler M, Cormier Y; HP Study Group. Clinical diagnosis of hypersensitivity pneumonitis. Am J Respir Crit Care Med. 2003 Oct 15;168(8):952-8. doi: 10.1164/rccm.200301-137OC. Epub 2003 Jul 3.
PubMed 12842854Selman M. Hypersensitivity pneumonitis: a multifaceted deceiving disorder. Clin Chest Med. 2004 Sep;25(3):531-47, vi. doi: 10.1016/j.ccm.2004.04.001.
PubMed 15331190Gaxiola M, Buendia-Roldan I, Mejia M, Carrillo G, Estrada A, Navarro MC, Rojas-Serrano J, Selman M. Morphologic diversity of chronic pigeon breeder's disease: clinical features and survival. Respir Med. 2011 Apr;105(4):608-14. doi: 10.1016/j.rmed.2010.11.026. Epub 2010 Dec 16.
PubMed 21167698Macias-Barragan J, Sandoval-Rodriguez A, Navarro-Partida J, Armendariz-Borunda J. The multifaceted role of pirfenidone and its novel targets. Fibrogenesis Tissue Repair. 2010 Sep 1;3:16. doi: 10.1186/1755-1536-3-16.
PubMed 20809935Selman M, Pardo A, Richeldi L, Cerri S. Emerging drugs for idiopathic pulmonary fibrosis. Expert Opin Emerg Drugs. 2011 Jun;16(2):341-62. doi: 10.1517/14728214.2011.565049. Epub 2011 Mar 17.
PubMed 21410428Schaefer CJ, Ruhrmund DW, Pan L, Seiwert SD, Kossen K. Antifibrotic activities of pirfenidone in animal models. Eur Respir Rev. 2011 Jun;20(120):85-97. doi: 10.1183/09059180.00001111.
PubMed 21632796Mateos-Toledo H, Mejia-Avila M, Rodriguez-Barreto O, Mejia-Hurtado JG, Rojas-Serrano J, Estrada A, Castillo-Pedroza J, Castillo-Castillo K, Gaxiola M, Buendia-Roldan I, Selman M. An Open-label Study With Pirfenidone on Chronic Hypersensitivity Pneumonitis. Arch Bronconeumol (Engl Ed). 2020 Mar;56(3):163-169. doi: 10.1016/j.arbres.2019.08.019. Epub 2019 Nov 26. English, Spanish.
PubMed 31784348
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pirfenidone in the Chronic Hypersensitivity Pneumonitis Treatment
- ClinicalTrials.gov ID
- NCT02496182
- Acronym / sponsor ID
- Picheon / C34-11
- Conditions
- Alveolitis Extrinsic Allergic, Pulmonary Fibrosis
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Grupo Medifarma, S. A. de C. V.Industry (pharma, biotech, devices)
- Study start
- Jul 2015
- Primary completion
- Jan 2016 (estimated)
- Study completion
- Jan 2017 (estimated)
- First posted
- 14 Jul 2015 (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.
The Chronic Hypersensitivity Pneumonitis (HP), is an inflammatory disease who has an evolution to develop progressive interstitial fibrosis, who cause the death of the patient. Actually HP has been treated with Prednisone and occasionally with Azathioprine, but unfortunately the treatment with these drugs have not an effective result to treat the interstitial fibrosis.
Pirfenidone has been studied over the world for the treatment of Fibrotic diseases, with positive results, and due to the Pirfenidone mechanism of action has anti-inflammatory and anti-fibrotic properties, the investigators propose to evaluate the addition of Pirfenidone to the actual treatment with Prednisone and Azathioprine in the treatment of patients with Pulmonary Fibrosis secondary to a Chronic Hypersensitivity Pneumonitis.
Detailed description
The Chronic Hypersensitivity Pneumonitis (HP), is a complex syndrome due to a exaggerated immune response caused by inhalation of foreign substances, such as molds, dusts, and organic particles, causing alveoli inflammation and in the chronic forms the disease has high rate of mortality, due to the big number of patients who develop progressive interstitial fibrosis and eventually they curse with respiratory insufficiency who cause the death of the patient.
Pirfenidone has been studied over the world for the treatment of Idiophatic Pulmonary Fibrosis (IPF), disease who constitute the most aggressive of the fibrotic diseases of the lung. Additionally Pirfenidone has been showed potential results in the treatment of fibrotic diseases in other organs, as Liver, Kidney, Hearth, etc. Pirfenidone has been described as a modulator of the fibrotic process due to his action over TGF-beta and MMP´s and also has into-inflammatory actions acting over TNF-alfa and IL-1 and IL-6.
Actually HP has been treated with Prednisone and occasionally with Azathioprine, but a high number of patients will develop irreversibly to a interstitial fibrosis with pulmonary parenchyma destruction. Unfortunately the investigators have not an effective treatment for this cases. Due to the positive results obtained with Pirfenidone in the treatment of IPF and other kind of organ fibrosis, the investigators propose to evaluate the addition of Pirfenidone to the treatment with Prednisone and Azathioprine in the treatment of patients with Pulmonary Fibrosis secondary to a Chronic Hypersensitivity Pneumonitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboConventional treatment (Prednisone 0.5 mg/kg/day for 4 weeks, then 0.25 mg/Kg/day for 8 weeks and maintenance dosage of 0.125 mg/Kg/day plus Azathioprine 2-3 mg/kg/day with a maximal dosage of 150 mg/day starting with 25-50 mg/day increasing gradually until day 14 with maximal dosage) plus Placebo tablet 2 times at day. |
| Pirfenidone 1800 mg | Experimental | Drug: PirfenidoneConventional treatment (0.5 mg/kg/day for 4 weeks, then 0.25 mg/Kg/day for 8 weeks and maintenance dosage of 0.125 mg/Kg/day plus Azathioprine 2-3 mg/kg/day with a maximal dosage of 150 mg/day starting with 25-50 mg/day increasing gradually until day 14 with maximal dosage) plus Pirfenidone long release tablet 900 mg 2 times at day, starting with 600 mg at day |
| Pirfenidone 1200 mg | Experimental | Drug: PirfenidoneConventional treatment (0.5 mg/kg/day for 4 weeks, then 0.25 mg/Kg/day for 8 weeks and maintenance dosage of 0.125 mg/Kg/day plus Azathioprine 2-3 mg/kg/day with a maximal dosage of 150 mg/day starting with 25-50 mg/day increasing gradually until day 14 with maximal dosage) plus Pirfenidone long release tablet 600 mg 2 times at day starting with 600 mg at day |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Chronic Hypersensitivity pneumonitis with recent diagnosis confirmed by HRT with or without biopsy
- Acceptation with signed informed consent
Key exclusion criteria (13 listed)
- No confirmed diagnosis
- Patients with peptic ulcer
- Pregnancy or breast feeding period
- Clinical signs of active infection
- History of severe Hepatic disease
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 |
|---|---|---|
| PlaceboAlso: Excipient TabletPlacebo tablet only with the excipients of the Pirfenidone tablet | Drug | Placebo |
| PirfenidoneAlso: Kitoscell LPConventional Treatment (Prednisone+Azathioprine) plus Pirfenidone 1800 mg | Drug | Pirfenidone 1800 mg |
| PirfenidoneAlso: KitosCell LPConventional Treatment (Prednisone+Azathioprine) plus Pirfenidone 1200 mg | Drug | Pirfenidone 1200 mg |
Primary outcome
Forced Vital Capacity (FVC)
Time frame: 52 weeks
The measurement of FVC will be at 26 and 52 weeks
5 secondary outcomes
High Resolution Tomography
Time frame: 52 weeks
6 minutes walk distance test
Time frame: 52 weeks
San George Qty Score, SOBQ and EQ5D Quality Scores
Time frame: 52 weeks
Pulmonary artery systolic pressure with echocardiogram
Time frame: 52 weeks
Oxygen desaturation in exercise
Time frame: 52 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2015.
- Background: PubMed 12842854Lacasse Y, Selman M, Costabel U, Dalphin JC, Ando M, Morell F, Erkinjuntti-Pekkanen R, Muller N, Colby TV, Schuyler M, Cormier Y; HP Study Group. Clinical diagnosis of hypersensitivity pneumonitis. Am J Respir Crit Care Med. 2003 Oct 15;168(8):952-8. doi: 10.1164/rccm.200301-137OC. Epub 2003 Jul 3.
- Background: PubMed 15331190Selman M. Hypersensitivity pneumonitis: a multifaceted deceiving disorder. Clin Chest Med. 2004 Sep;25(3):531-47, vi. doi: 10.1016/j.ccm.2004.04.001.
- Background: PubMed 21167698Gaxiola M, Buendia-Roldan I, Mejia M, Carrillo G, Estrada A, Navarro MC, Rojas-Serrano J, Selman M. Morphologic diversity of chronic pigeon breeder's disease: clinical features and survival. Respir Med. 2011 Apr;105(4):608-14. doi: 10.1016/j.rmed.2010.11.026. Epub 2010 Dec 16.
- Background: PubMed 20809935Macias-Barragan J, Sandoval-Rodriguez A, Navarro-Partida J, Armendariz-Borunda J. The multifaceted role of pirfenidone and its novel targets. Fibrogenesis Tissue Repair. 2010 Sep 1;3:16. doi: 10.1186/1755-1536-3-16.
- Background: PubMed 21410428Selman M, Pardo A, Richeldi L, Cerri S. Emerging drugs for idiopathic pulmonary fibrosis. Expert Opin Emerg Drugs. 2011 Jun;16(2):341-62. doi: 10.1517/14728214.2011.565049. Epub 2011 Mar 17.
- Background: PubMed 21632796Schaefer CJ, Ruhrmund DW, Pan L, Seiwert SD, Kossen K. Antifibrotic activities of pirfenidone in animal models. Eur Respir Rev. 2011 Jun;20(120):85-97. doi: 10.1183/09059180.00001111.
- Derived from this study: PubMed 31784348Mateos-Toledo H, Mejia-Avila M, Rodriguez-Barreto O, Mejia-Hurtado JG, Rojas-Serrano J, Estrada A, Castillo-Pedroza J, Castillo-Castillo K, Gaxiola M, Buendia-Roldan I, Selman M. An Open-label Study With Pirfenidone on Chronic Hypersensitivity Pneumonitis. Arch Bronconeumol (Engl Ed). 2020 Mar;56(3):163-169. doi: 10.1016/j.arbres.2019.08.019. Epub 2019 Nov 26. English, Spanish.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Pirfenidone in people with Alveolitis Extrinsic Allergic and Pulmonary Fibrosis, run by Grupo Medifarma, S. A. de C. V. at 1 site in Mexico.
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 2 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 14 Jul 2015. 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 Mexico. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pedro Pena, MD (+52191971972, pedropena@grupomedifarma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Forced Vital Capacity (FVC) (time frame: 52 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02496182, which also lists 7 linked publications.
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 Jul 2015.