IPF Italian Observational Study (FIBRONET) in Idiopathic Pulmonary Fibrosis
NCT ID: NCT02803580
Last Updated: 2019-09-13
Study Results
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View full resultsBasic Information
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COMPLETED
209 participants
OBSERVATIONAL
2015-11-17
2018-05-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
2. Written informed consent to both participation in the study and privacy
3. Physician diagnosed IPF during the last 3 months based upon recent American Thoracic Society/European Resp. Society/Japanese Resp. Society/Latin American Thoracic Association guidelines 2011 (see Tables A1-A2 for High Resolution Chest Computer Tomography and histology criteria):
* Exclusion of other known causes of Interstitial Lung Disease (e.g. domestic and occupational environmental exposures, connective tissue disease and drug toxicity)
* Assessment of Idiopathic Pulmonary Fibrosis based on High Resolution Computed Tomography (HRCT) or HRCT and surgical lung biopsy if available.
4. Patient with further follow-up possible with enrolling investigator during planned study period
5. Patients capable of discernment and able to read or write in Italian language.
Exclusion Criteria
2. Lung transplantation expected within the next 6 months
3. Pregnancy or breast feeding
40 Years
99 Years
ALL
No
Sponsors
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Boehringer Ingelheim
INDUSTRY
Responsible Party
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Principal Investigators
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Boehringer Ingelheim
Role: STUDY_CHAIR
Boehringer Ingelheim
Locations
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A.O.U. Policlinico Vittorio Emanuele
Catania, , Italy
Osp. Clin. SS. Anunziata
Chieti, , Italy
Ospedale Colonnello D Avanzo
Foggia, , Italy
Ospedale "G.B. Morgagni - L. Pierantoni" ausl forli
Forlì, , Italy
Osp. S. Giuseppe Fatebenefratelli
Milan, , Italy
Azienda Ospedaliera Policlinico di Modena
Modena, , Italy
A.O. San Gerardo di Monza
Monza, , Italy
Azienda Ospedaliera Universitaria "Federico II"
Napoli, , Italy
Azienda Sanitaria Ospedale S. Luigi Gonzaga
Orbassano, , Italy
Azienda Ospedaliera Universitaria di Padova
Padua, , Italy
Fondazione IRCCS Policlinico S. Matteo
Pavia, , Italy
Ospedale di Cisanello
Pisa, , Italy
Pol. Universitario Tor Vergata
Roma, , Italy
A.O. San Camillo Forlanini
Roma, , Italy
Policlinico Gemelli
Roma, , Italy
Policlinico Universitario di Sassari
Sassari, , Italy
A.O.U. Senese Policlinico Santa Maria alle Scotte
Siena, , Italy
Ospedale Riuniti di Ancona
Torrette-Ancona, , Italy
Countries
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References
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Poletti V, Vancheri C, Albera C, Harari S, Pesci A, Metella RR, Campolo B, Crespi G, Rizzoli S; FIBRONET study group. Clinical course of IPF in Italian patients during 12 months of observation: results from the FIBRONET observational study. Respir Res. 2021 Feb 24;22(1):66. doi: 10.1186/s12931-021-01643-w.
Provided Documents
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Document Type: Statistical Analysis Plan
Document Type: Study Protocol
Other Identifiers
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1199.262
Identifier Type: -
Identifier Source: org_study_id
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