Lung Diseases, Interstitial Clinical Trial
Official title:
Assessment of the Oxygen Use and Future Outcomes Associated With Oxygen Use in Patient With Fibrotic ILD
NCT number | NCT05957198 |
Other study ID # | 1199-0541 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | July 25, 2023 |
Est. completion date | September 26, 2023 |
Verified date | December 2023 |
Source | Boehringer Ingelheim |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The purpose of this study is to describe initiation and use of oxygen therapy among patients with fibrotic Interstitial Lung Disease (ILD) and to assess the impact of oxygen therapy on clinical outcomes among patients with fibrotic ILD.
Status | Completed |
Enrollment | 26212 |
Est. completion date | September 26, 2023 |
Est. primary completion date | September 26, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion criteria: - =2 fibrosing Interstitial Lung Disease (ILD) diagnoses in any position on different dates of service, within 365 days of each other, and in the same continuous enrollment period during the patient identification period. The fibrosing ILD diagnosis date will be defined as the date of the first fibrosing ILD diagnosis. The two fibrosing ILD diagnosis codes can be one of the following combinations: - 2 fibrosis codes - 1 fibrosis code & 1 ILD code that requires fibrosis code - =18 years of age as of the fibrosing ILD diagnosis date - Continuous enrollment with medical and pharmacy coverage for 12 months prior to the fibrosing ILD diagnosis date (pre-ILD baseline period) Exclusion criteria: - Fibrosing ILD diagnosis in the 12-month pre-ILD baseline period - Unknown gender, geographic region, or insurance type |
Country | Name | City | State |
---|---|---|---|
United States | Boehringer Ingelheim Pharmaceuticals, Inc. | Ridgefield | Connecticut |
Lead Sponsor | Collaborator |
---|---|
Boehringer Ingelheim |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Time to oxygen therapy initiation | Time in days from the fibrosing Interstitial Lung Disease (ILD) diagnosis date to oxygen therapy initiation. | Up to 5.7 years | |
Primary | Time to sustained oxygen therapy use | Time in days between the fibrosing ILD diagnosis date and the earliest date that defined the sustained oxygen therapy use. | Up to 5.7 years | |
Primary | Sustained oxygen therapy use within the first 12 months of follow-up | The number of patients with the evidence of sustained oxygen therapy use during the first 12 months of follow-up. | Up to month 12 of follow-up | |
Primary | Time to disease progression | Disease progression will be defined as a 10% relative change between the forced vital capacity (FVC) pre-index value and the follow-up value. | Up to 5.7 years | |
Primary | Time to all-cause mortality | Time to all-cause mortality will be calculated as time between index date and mortality date. | Up to 5.7 years | |
Secondary | Incidence rate of hypoxemia | Hypoxemia will be defined as oxygen saturation [SpO2] inferior to 90 percent (%). | Up to 5.7 years | |
Secondary | Incidence rate of respiratory deterioration/acute exacerbations | Up to 5.7 years | ||
Secondary | Number of exacerbations episodes patients experienced | Up to 5.7 years |
Status | Clinical Trial | Phase | |
---|---|---|---|
Terminated |
NCT04119115 -
Integrated Radiographic and Metabolomics Risk Assessment in Patients With Interstitial Lung Diseases
|
||
Active, not recruiting |
NCT04559581 -
Post-marketing Surveillance of Ofev Capsules in Chronic Fibrosing Interstitial Lung Diseases With a Progressive Phenotype in Japan
|
||
Recruiting |
NCT05151640 -
INCHANGE - Nintedanib for Changes in Cough and Dyspnea in Patients Suffering From Chronic Fibrosing Interstitial Lung Disease With a Progressive Phenotype in Everyday Clinical Practice: a Real-world Evaluation
|
||
Recruiting |
NCT02543073 -
MSC for Treatment of Interstitial Lung Disease After Allo-HSCT
|
Phase 1/Phase 2 | |
Completed |
NCT02251964 -
Rituximab in Interstitial Pneumonitis
|
Phase 2/Phase 3 | |
Terminated |
NCT01432080 -
Steroids, Azithromycin, Montelukast, and Symbicort (SAMS) for Viral Respiratory Tract Infection Post Allotransplant
|
Phase 2 | |
Completed |
NCT01442779 -
Clinical Trial of Low Dose Oral Interferon Alpha in Idiopathic Pulmonary Fibrosis
|
Phase 2 | |
Recruiting |
NCT05596760 -
Promoting Goals-of-Care Discussions for Patients With Memory Problems and Their Caregivers
|
N/A | |
Recruiting |
NCT05866198 -
Physical Activity and Quality of Life in Fibrotic Lung Diseases After Initiating Anti-fibrotic Therapy and Pulmonary Rehabilitation
|
N/A | |
Active, not recruiting |
NCT05321082 -
A Study to Find Out Whether BI 1015550 Improves Lung Function in People With Progressive Fibrosing Interstitial Lung Diseases (PF-ILDs)
|
Phase 3 | |
Completed |
NCT04016168 -
Idiopathic Pulmonary Fibrosis and Serum Bank
|
||
Recruiting |
NCT00258583 -
Dorothy P. and Richard P. Simmons Center for ILD Research Registry
|
||
Recruiting |
NCT05855109 -
Developing a Screening Tool for Interstitial Lung Disease in People With Rheumatoid Arthritis Using Risk Factors
|
||
Completed |
NCT05719233 -
Assessment of Neuropsychiatric Function in Patients With Interstitial Lung Disease
|
||
Recruiting |
NCT04159129 -
Effects of Pulmonary Rehabilitation on Walking Speed in Patients With COPD or ILD Patients
|
||
Completed |
NCT03313180 -
A Trial to Evaluate the Safety of Long Term Treatment With Nintedanib in Patients With Scleroderma Related Lung Fibrosis
|
Phase 3 | |
Completed |
NCT05065190 -
A Study to Test How Well a Medicine Called Nintedanib Helps People in China With Progressive Lung Fibrosis
|
Phase 3 | |
Completed |
NCT03136120 -
Cryobiopsy Study to Assess Drug Distribution in Subjects With Suspected Interstitial Lung Disease
|
||
Recruiting |
NCT04930666 -
BREATHE ALD: A Shared Decision-Making Intervention for Adults With Advanced Lung Disease
|
||
Recruiting |
NCT05503030 -
Correlation Between Changes in Lung Function and Changes in Cough and Dyspnoea in Nintedanib-treated Connective Tissue Disease Interstitial Lung Disease (CTD-ILD) Patients
|