18 and older, any sex, with Lung Diseases, Interstitial. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Incidence Probability of Progression to Pulmonary Fibrosing-Interstitial Lung Disease (PF-ILDs)Primary· At 6, 12, 18 and 24 months after the index date, defined between 01-Jan-2013 and 6 months before 28-May-2020
The cumulative incidence probability is the estimate of the risk a patient will experience by 6, 12, 18 and 24 months after the second diagnosis of fibrosing ILD (index date) of progression to PF-ILDs. It is the complement of the Kaplan-Meier estimates. The Greenwood's variance estimate was used to calculate the 95% confidence interval.
Disease progression was defined as 3 or more pulmonary function tests within 365 days, 3 or more tomographies within 365 days, 1 or more claims for oxygen therapy during follow-up, 1 or more respiratory hospitalizations during follow-up, 1 or more claims for p
6 months
Group
Value
95% CI
Patients With an ILD Other Than IPF
0.147
0.143 – 0.151
12 months
Group
Value
95% CI
Patients With an ILD Other Than IPF
0.249
0.244 – 0.253
18 months
Group
Value
95% CI
Patients With an ILD Other Than IPF
0.334
0.329 – 0.34
24 months
Group
Value
95% CI
Patients With an ILD Other Than IPF
0.395
0.389 – 0.401
Number of Patients With Treatment of Interest During Follow-up PeriodSecondary· Up to 7.43 years, from 01-Jan-2013 to 28-May-2020
Number of patients treated with immunosuppressive drugs (Rituximab, Tacrolimus, Mycophenolate, Cyclosporine, Cyclophosphamide, Azathioprine, Tocilizumab), oral corticosteroids, or nintedanib during the follow-up period. The follow-up period was between the second diagnosis of a fibrosing ILD (index date) and end of study (28-May-2020), the last encounter in Medical Data Vision database, or in-hospital death, whichever occurs first.
Rituximab
Group
Value
95% CI
Patients With an ILD Other Than IPF
49
Tacrolimus
Group
Value
95% CI
Patients With an ILD Other Than IPF
499
Mycophenolate
Group
Value
95% CI
Patients With an ILD Other Than IPF
30
Cyclosporine
Group
Value
95% CI
Patients With an ILD Other Than IPF
200
Cyclophosphamide
Group
Value
95% CI
Patients With an ILD Other Than IPF
225
Azathioprine
Group
Value
95% CI
Patients With an ILD Other Than IPF
201
Oral corticosteroid
Group
Value
95% CI
Patients With an ILD Other Than IPF
2065
Tocilizumab
Group
Value
95% CI
Patients With an ILD Other Than IPF
46
Number of Patients With Management of Interest During Follow-up PeriodSecondary· Up to 7.43 years, from 01-Jan-2013 to 28-May-2020
Number of patients with oxygen therapy (HOT), lung transplant and palliative care (oxygen inhalation, opioid use) as disease management during the follow-up period. The follow-up period was between the second diagnosis of a fibrosing ILD (index date) and end of study (28-May-2020), the last encounter in Medical Data Vision database, or in-hospital death, whichever occurs first.
Oxygen therapy (HOT)
Group
Value
95% CI
Patients With an ILD Other Than IPF
1641
Lung transplant
Group
Value
95% CI
Patients With an ILD Other Than IPF
0
Palliative care (oxygen inhalation, opioid use)
Group
Value
95% CI
Patients With an ILD Other Than IPF
9520
Sponsor's own description
The primary objective for this trial is to investigate the incidence probability of progression to Progressive Fibrosing Interstitial Lung Diseases (PF-ILDs) in patients with fibrosing ILD other than Idiopathic Pulmonary Fibrosis (IPF) in real-world setting in Japan.
The secondary objective is to investigate the characteristics of procedures for management and treatment in patients with fibrosing ILD other than IPF in real-world setting in Japan.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Sponsor: as reported to ClinicalTrials.gov by Boehringer Ingelheim
Last refreshed: 19 September 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05875532.