Ignite Creation Date:
2024-05-06 @ 7:54 PM
Last Modification Date:
2024-10-26 @ 3:16 PM
Study NCT ID:
NCT06170125
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-02-20
First Post:
2023-11-28
Brief Title:
QualiTy of Life Evaluation in Patients With ChRonic ObstructIve Pulmonary Disease Who Require Tiotropium as additiOnal treatmeNt
Sponsor:
Elpen Pharmaceutical Co Inc
Organization:
Elpen Pharmaceutical Co Inc
Study Overview
Official Title:
A Multicenter Non-interventional Observational Clinical Trial to Assess the Quality of Life in Patients With ChRonic ObstructIve Pulmonary Disease Who Require Tiotropium as additiOnal treatmeNt
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TRITON
Brief Summary:
Chronic obstructive pulmonary disease COPD is a complex heterogeneous disease usually with a decline lung function and worsening symptoms hence both forced expiratory volume in 1 s FEV1 lung function and validated patient-reported outcomes PROs are used in clinical trials to assess disease severity and response to treatment
The PROs are different in terms of their scope of assessment and in the information that they capture PRO questionnaires such as the Baseline Dyspnoea Index BDI Transition Dyspnoea Index TDI and modified Medical Research Council mMRC dyspnoea scale are used to assess dyspnoea whereas the Clinical COPD Questionnaire CCQ COPD Assessment Test CAT and St Georges Respiratory Questionnaire SGRQ are commonly used to assess patients health status
Furthermore the mMRC scale is unidirectional and minimally responsive to treatment interventions while the BDI TDI CAT CCQ and SGRQ approved by the USA Food and Drug Administration are multidirectional
The PROs are different in terms of their scope of assessment and in the information that they capture PRO questionnaires such as the Baseline Dyspnoea Index BDI Transition Dyspnoea Index TDI and modified Medical Research Council mMRC dyspnoea scale are used to assess dyspnoea whereas the Clinical COPD Questionnaire CCQ COPD Assessment Test CAT and St Georges Respiratory Questionnaire SGRQ are commonly used to assess patients health status
Furthermore the mMRC scale is unidirectional and minimally responsive to treatment interventions while the BDI TDI CAT CCQ and SGRQ approved by the USA Food and Drug Administration are multidirectional
Detailed Description:
With the availability of numerous PROs it is important to understand which provide a better evaluation of patients health status and demonstrate responses to treatment Even when PROs evaluate the same parameter eg dyspnoea they may not always capture a uniform response Hence it would be useful to examine if the PROs correlate with each other and whether any specific PROs better reflect treatment benefit as expressed by minimal clinically important differences MCIDs than the others Furthermore understanding the relationship between the PROs and lung function FEV1 may provide insights into whether a change in lung function translates to a change perceptible by the patients assessed through PROs
Tiotropium is a potent long-acting selective anticholinergic bronchodilator Treatment with tiotropium produces sustained improvements in lung function particularly FEV1 peak trough average and area under the curve compared with either placebo or ipratropium in patients with moderate to severe COPD Preliminary evidence suggests that treatment with tiotropium may slow the rate of decline in FEV1 but this finding awaits confirmation Tiotropium reduces lung hyperinflation with associated improvements in exercise capacity Tiotropium compared with either placebo or ipratropium improves a variety of patient-centered outcomes including subjective dyspnea ratings and Health Related Quality of Life HRQL scores Tiotropium reduces the frequency of COPD exacerbations and of hospitalizations due to exacerbations but has not been shown to reduce all-cause mortality Compared with the long-acting bronchodilators tiotropium provides incrementally better bronchodilation but it is not clearly superior in terms of patient-centered outcomes Tiotropium has a good safety profile however patients with severe cardiac disease bladder outlet obstruction or narrow angle glaucoma were excluded from all studies
Tiotropium is a potent long-acting selective anticholinergic bronchodilator Treatment with tiotropium produces sustained improvements in lung function particularly FEV1 peak trough average and area under the curve compared with either placebo or ipratropium in patients with moderate to severe COPD Preliminary evidence suggests that treatment with tiotropium may slow the rate of decline in FEV1 but this finding awaits confirmation Tiotropium reduces lung hyperinflation with associated improvements in exercise capacity Tiotropium compared with either placebo or ipratropium improves a variety of patient-centered outcomes including subjective dyspnea ratings and Health Related Quality of Life HRQL scores Tiotropium reduces the frequency of COPD exacerbations and of hospitalizations due to exacerbations but has not been shown to reduce all-cause mortality Compared with the long-acting bronchodilators tiotropium provides incrementally better bronchodilation but it is not clearly superior in terms of patient-centered outcomes Tiotropium has a good safety profile however patients with severe cardiac disease bladder outlet obstruction or narrow angle glaucoma were excluded from all studies
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None