Clinical trial NCT03242759: Non-Interventional Study (NIS) Collecting Experiences For IPF in Taiwan
Official title: Non-Interventional Study (NIS) Collecting Experiences For IPF in Taiwan
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Fibrosis
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2017-08-08
Enrollment: 101
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study will be carried out at 10 medical centers, the expert centers where idiopathic pulmonary fibrosis (IPF) patients are mainly managed in Taiwan.

Brief summary: This is a non-interventional, multi-center study to collect data from patients with idiopathic pulmonary fibrosis (IPF) in clinical practice in Taiwan. The study will be carried out at 10 medical centers, the expert centers where IPF patients are mainly managed in Taiwan.


Eligibility criteria: Inclusion Criteria:

* Patients can be included if ALL the following criteria are met:

  1.Newly diagnosed with IPF within 6 months based upon recent ATS/ERS/JRS/ALAT IPF guideline (Ref 1, Raghu G, et al. 2011).
* Exclusion of other known causes of ILD (e.g. domestic and occupational environmental exposures, connective tissue disease, and drug toxicity).
* Assessment of IPF based on HRCT or HRCT and surgical lung biopsy, if available. 2.Patient ≥ 20 years of age 3.Written informed consent prior to participation 4.Patients with further follow-up possible with participating physician during planned study period 5.Ability to read and write in the local language

Exclusion Criteria:

* Patients should not be included if ANY of the following criteria is met:

  1. Lung transplantation expected within next 6 months.
  2. Inclusion in ongoing clinical trials.

Primary outcomes:
measure: Annual Change From Baseline in Percentage of Predicted Forced Vital Capacity (FVC) at Week 52
timeFrame: At baseline and Week 52.
measure: Annual Change From Baseline in Percentage of Predicted Forced Vital Capacity (FVC) at Week 100
timeFrame: At baseline and Week 100.
measure: Annual Change From Baseline in Percentage of Predicted Diffusing Capacity of the Lungs for Carbon Monoxide (DLco) at Week 52
timeFrame: At baseline and Week 52.
measure: Annual Change From Baseline in Percentage of Predicted Diffusing Capacity of the Lungs for Carbon Monoxide (DLco) at Week 100
timeFrame: At baseline and Week 100.
measure: Annual Change From Baseline in Percentage of Predicted Oxygen Saturation (SpO2) at Week 52
timeFrame: At baseline and Week 52.
measure: Annual Change From Baseline in Percentage of Predicted Oxygen Saturation (SpO2) at Week 100
timeFrame: At baseline and Week 100.
measure: Annual Change From Baseline in Percentage of Predicted Total Lung Capacity (TLC) at Week 52
timeFrame: At baseline and Week 52.
measure: Annual Change From Baseline in Percentage of Predicted Total Lung Capacity (TLC) at Week 100
timeFrame: At baseline and Week 100.
measure: Annual Change From Baseline in Percentage of Predicted Inspiratory Capacity (IC) at Week 52
timeFrame: At baseline and Week 52.
measure: Annual Change From Baseline in Percentage of Predicted Inspiratory Capacity (IC) at Week 100
timeFrame: At baseline and Week 100.
Secondary outcomes:
measure: Time to First Acute Exacerbation of Idiopathic Pulmonary Fibrosis
timeFrame: From baseline until end of follow-up, up to 899 days.
measure: Annual Change in Total Score of St. Georges Respiratory Questionnaire (SGRQ) at Week 52
timeFrame: At baseline and Week 52.
measure: Annual Change in Total Score of St. Georges Respiratory Questionnaire (SGRQ) at Week 100
timeFrame: At baseline and Week 100.
measure: Annual Change in Score of Chronic Obstructive Pulmonary Disease Assessment Test (CAT) at Week 52
timeFrame: At baseline and Week 52
measure: Annual Change in Score of Chronic Obstructive Pulmonary Disease Assessment Test (CAT) at Week 100
timeFrame: At baseline and Week 100
measure: Annual Change in Six-Minute Walk Test (6MWT) at Week 52
timeFrame: At baseline and Week 52.
measure: Annual Change in Six-Minute Walk Test (6MWT) at Week 100
timeFrame: At baseline and Week 100.
measure: Overall Survival
timeFrame: From baseline until end of follow-up, up to 899 days.
measure: Number of Participants Per Death Reason Categories
timeFrame: From baseline until end of follow-up, up to 899 days.
Other outcomes:
Locations:
city: Changhua
country: Taiwan
facility: Chang-Hua Christian Hospital
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University Chung-Ho Memorial Hospital
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Chang Gung Memorial Hospital
city: New Taipei
country: Taiwan
facility: Far Eastern Memorial Hospital
city: Taichung
country: Taiwan
facility: China Medical University Hospital
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
city: Taipei
country: Taiwan
facility: Tri-Service General Hospital
city: Tao-Yuan
country: Taiwan
facility: Chang Gung Memorial Hospital(Linkou)
Study officials:
References: