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Non-Interventional Study (NIS) Collecting Experiences For IPF in Taiwan
trial testing nintedanib in Pulmonary Fibrosis in 101 participants. Completed in 18 February 2020.
| Lead sponsor | Boehringer Ingelheim |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 101 |
| Start date | 17 August 2017 |
| Primary completion | 18 February 2020 |
| Estimated completion | 18 February 2020 |
| Sites | 10 locations across Taiwan |
Boehringer Ingelheim — full company profile →
20 and older, any sex, with Pulmonary Fibrosis. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Annual Change from Baseline in percentage of predicted Forced Vital Capacity (FVC) at Week 52 was reported.
| Group | Value | 95% CI |
|---|---|---|
| Idiopathic Pulmonary Fibrosis With Anti-fibrotic Drug | -0.5 | ± 10.78 |
| Idiopathic Pulmonary Fibrosis Without Anti-fibrotic Drug | 4.1 | ± 7.73 |
Annual Change from Baseline in percentage of predicted Forced Vital Capacity (FVC) at Week 100 was reported.
| Group | Value | 95% CI |
|---|---|---|
| Idiopathic Pulmonary Fibrosis With Anti-fibrotic Drug | -0.2 | ± 7.74 |
| Idiopathic Pulmonary Fibrosis Without Anti-fibrotic Drug | -2.5 | ± 4.52 |
Annual Change from Baseline in percentage of predicted Diffusing capacity of the Lungs for Carbon monoxide (DLco) at Week 52 was reported
| Group | Value | 95% CI |
|---|---|---|
| Idiopathic Pulmonary Fibrosis With Anti-fibrotic Drug | -7.3 | ± 10.47 |
| Idiopathic Pulmonary Fibrosis Without Anti-fibrotic Drug | -2.8 | ± 8.27 |
Annual Change from Baseline in percentage of predicted Diffusing capacity of the Lungs for Carbon monoxide (DLco) at Week 100 was reported.
| Group | Value | 95% CI |
|---|---|---|
| Idiopathic Pulmonary Fibrosis With Anti-fibrotic Drug | 0.5 | ± 6.83 |
| Idiopathic Pulmonary Fibrosis Without Anti-fibrotic Drug | -2.6 | ± 6.26 |
Annual Change from Baseline in percentage of predicted oxygen saturation (SpO2) at Week 52 was reported.
| Group | Value | 95% CI |
|---|---|---|
| Idiopathic Pulmonary Fibrosis With Anti-fibrotic Drug | -0.8 | ± 2.22 |
| Idiopathic Pulmonary Fibrosis Without Anti-fibrotic Drug | -0.8 | ± 0.92 |
Annual Change from Baseline in percentage of predicted oxygen saturation (SpO2) at Week 100 was reported.
| Group | Value | 95% CI |
|---|---|---|
| Idiopathic Pulmonary Fibrosis With Anti-fibrotic Drug | -0.2 | ± 0.96 |
| Idiopathic Pulmonary Fibrosis Without Anti-fibrotic Drug | -0.6 | ± 0.84 |
Annual Change from Baseline in percentage of predicted Total Lung Capacity (TLC) at Week 52was reported.
| Group | Value | 95% CI |
|---|---|---|
| Idiopathic Pulmonary Fibrosis With Anti-fibrotic Drug | -0.4 | ± 9.97 |
| Idiopathic Pulmonary Fibrosis Without Anti-fibrotic Drug | -1.4 | ± 12.18 |
Annual Change from Baseline in percentage of predicted Total Lung Capacity (TLC) at Week 100 was reported.
| Group | Value | 95% CI |
|---|---|---|
| Idiopathic Pulmonary Fibrosis With Anti-fibrotic Drug | -2.3 | ± 3.76 |
| Idiopathic Pulmonary Fibrosis Without Anti-fibrotic Drug | -3.4 | ± 6.89 |
Annual Change from Baseline in percentage of predicted Inspiratory Capacity (IC) at Week 52 was reported.
| Group | Value | 95% CI |
|---|---|---|
| Idiopathic Pulmonary Fibrosis With Anti-fibrotic Drug | -6.8 | ± 10.18 |
| Idiopathic Pulmonary Fibrosis Without Anti-fibrotic Drug | -6.1 | ± 1.73 |
Annual Change from Baseline in percentage of predicted Inspiratory Capacity (IC) at Week 100 was reported.
| Group | Value | 95% CI |
|---|---|---|
| Idiopathic Pulmonary Fibrosis With Anti-fibrotic Drug | -4.5 | ± 5.00 |
| Idiopathic Pulmonary Fibrosis Without Anti-fibrotic Drug | -6.0 | ± 2.40 |
Time to first acute exacerbation of idiopathic pulmonary fibrosis was reported.
| Group | Value | 95% CI |
|---|---|---|
| Idiopathic Pulmonary Fibrosis With Anti-fibrotic Drug | 497.0 | 6.0 – 751.0 |
| Idiopathic Pulmonary Fibrosis Without Anti-fibrotic Drug | 521.5 | 111.0 – 721.0 |
The SGRQ is a 50-item questionnaire developed to measure health status (quality of life) in patients with diseases of airways obstruction. The questionnaire included 3 subscales measures: symptoms, activity limitation, and social, and emotional impact of disease (each subscale score ranges from 0 to 100 with higher score indicating poorer quality of life). The SGRQ total score was calculated by summing weights from all positive items, divided by sum of weights for all items in SGRQ questionnaire and multiplying by 100. The total score of SGRQ ranged from 0 (no effect on quality of life) to 100
| Group | Value | 95% CI |
|---|---|---|
| Idiopathic Pulmonary Fibrosis With Anti-fibrotic Drug | 8.4 | ± 16.52 |
| Idiopathic Pulmonary Fibrosis Without Anti-fibrotic Drug | 0.2 | ± 8.12 |
Time frame: From baseline until end of follow-up, up to 899 days.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Idiopathic Pulmonary Fibro… | Idiopathic Pulmonary Fibro… |
|---|---|---|---|
| Death | General disorders | — | — |
| Pneumonia | Infections and infestations | — | — |
| Idiopathic pulmonary fibrosis | Respiratory, thoracic and mediastinal disorders | — | — |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | — | — |
| Anaemia of chronic disease | Blood and lymphatic system disorders | — | — |
| Acute myocardial infarction | Cardiac disorders | — | — |
| Atrioventricular block complete | Cardiac disorders | — | — |
| Bradycardia | Cardiac disorders | — | — |
| Cardiac arrest | Cardiac disorders | — | — |
| Myocardial infarction | Cardiac disorders | — | — |
| Pyrexia | General disorders | — | — |
| Hepatitis | Hepatobiliary disorders | — | — |
| Bacteraemia | Infections and infestations | — | — |
| Oral candidiasis | Infections and infestations | — | — |
| Sepsis | Infections and infestations | — | — |
| Septic shock | Infections and infestations | — | — |
| Urinary tract infection | Infections and infestations | — | — |
| Fall | Injury, poisoning and procedural complications | — | — |
| Alanine aminotransferase abnormal | Investigations | — | — |
| Aspartate aminotransferase abnormal | Investigations | — | — |
| Intraventricular haemorrhage | Nervous system disorders | — | — |
| Acute kidney injury | Renal and urinary disorders | — | — |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | — | — |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | — | — |
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | — | — |
| Reaction | System | Idiopathic Pulmonary Fibro… | Idiopathic Pulmonary Fibro… |
|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | — | — |
| Alanine aminotransferase abnormal | Investigations | — | — |
| Aspartate aminotransferase abnormal | Investigations | — | — |
| Decreased appetite | Metabolism and nutrition disorders | — | — |
| Pulmonary mass | Respiratory, thoracic and mediastinal disorders | — | — |
Most-reported serious reactions: Death, Pneumonia, Idiopathic pulmonary fibrosis, Respiratory failure, Anaemia of chronic disease, Acute myocardial infarction, Atrioventricular block complete, Bradycardia.
Data from ClinicalTrials.gov NCT03242759 adverse events section.
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.
1 peer-reviewed publication reference this trial (live from Europe PMC):
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