A Study to Characterize the Disease Behavior of Idiopathic Pulmonary Fibrosis (IPF) and Interstitial Lung Disease (ILD) During the Peri-Diagnostic Period

  • Idiopathic Pulmonary Fibrosis
Trial Status:

Completed

This trial runs in
Cities
  • Bron
  • Caen
  • Chelyabinsk
  • Chieti
  • Cork
  • Dublin 8
  • Firenze
  • Genova
  • Goes
  • Granville
  • Kemerovo
  • Kingston
  • Lille
  • Lombardia
  • Macerata
  • Modena
  • Montpellier
  • Napoli
  • Palermo
  • Paris
  • Pavia
  • Perpignan
  • Rennes
  • Roma
  • Rostov
  • Rotterdam
  • Saint-Charles-Borromée
  • Sanatorio San Luigi
  • Sankt-Peterburg
  • Sassari
  • St. John's
  • Vannes
  • Voronezh
  • Windsor
  • Zwolle
Trial Identifier:

NCT03261037 2016-005114-22 MA39297

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      The source of the below information is the publicly available website ClinicalTrials.gov. It has been summarised and edited into simpler language.

      The below information is taken directly from the publicly available website ClinicalTrials.gov within a week of any updates, and has not been edited.

      Results Disclaimer

      Trial Summary

      This international clinical study will enroll participants with a suspected diagnosis of IPF/ILD. This study will characterize the disease behavior of IPF and ILD in the peri-diagnostic period. This objective will be achieved using a multidimensional approach assessing changes in pulmonary function, measured by daily handheld spirometry and site spirometry as well as assessing physical functional capacity at home (accelerometry) and at site (6-minute walk tests [6MWT]). Daily handheld spirometry or physical functional capacity assessments are not routinely performed in this participant population. By following participants' lung function before and after diagnosis using home spirometry, levels of physical activity, as well as self-assessment data from the participants (patient reported outcomes; PRO), the study would provide potentially more rapid information on disease behavior and eventually progression compared to usual clinic measurements that occur only every 3-6 months. By receiving data from daily handheld spirometry measurements, treating physicians may have an improved chance of detecting earlier and outside of hospital visits a decline in lung function that could potentially lead to improvements in both diagnosis and treatment for participants with IPF/ILD.

      Hoffmann-La Roche Sponsor
      N/A Phase
      NCT03261037 , MA39297 , 2016-005114-22 Trial Identifier
      Spirometry, Accelerometry, 6MWT Treatments
      Idiopathic Pulmonary Fibrosis, Interstitial Lung Disease Condition
      Official Title

      An International Study to Characterize the Disease Behaviour of Idiopathic Pulmonary Fibrosis and Interstitial Lung Disease During the Peri-Diagnostic Period

      Eligibility Criteria

      All Gender
      ≥ 50 Years Age
      No Healthy Volunteers
      Inclusion Criteria
      • Able to comply with the study protocol, in the Investigator's judgment - for example, the ability to use the provided spirometer and tablet and the ability to fill in the required patient reported outcomes questionnaires
      • Suspicion of IPF/ILD: radiological evidence of IPF/ILD in symptomatic participants (unexplained dyspnea on exertion and/or cough)
      Exclusion Criteria
      • Participation in any investigational study within 28 days prior to inclusion
      • History of clinically significant cardiac disease that could explain the patient's symptomatology in the opinion of the Investigator
      • Known history of any connective tissue disease, including, but not limited to, rheumatoid arthritis, scleroderma, systemic lupus erythematosus, or mixed connective tissue disease

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