COPD Clinical Trial
— TRITONOfficial 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.
Verified date | January 2024 |
Source | Elpen Pharmaceutical Co. Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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 George's 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.
Status | Not yet recruiting |
Enrollment | 500 |
Est. completion date | February 2026 |
Est. primary completion date | March 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 40 Years to 90 Years |
Eligibility | Inclusion Criteria: 1. Adult patients (=40 years old) with a diagnosis of Chronic Respiratory Pulmonary Disease (COPD). 2. Patients who were treated with Inhaled Corticosteroid (ICS)/LABA, LABA/LAMA with a LABA or ICS/LABA or were not receiving long-acting bronchodilators (LABA or LAMA) for COPD and required addition of tiotropium from 1 to 7 days before the start of the study. 3. Patients who are able to provide informed consent and follow study procedures and requirements. Exclusion Criteria: 1. According to the contraindications of the product's Summary of Product Characteristics. 2. Patients receiving LAMA monotherapy prior to study entry. |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Elpen Pharmaceutical Co. Inc. |
Anzueto A, Miravitlles M. Tiotropium in chronic obstructive pulmonary disease - a review of clinical development. Respir Res. 2020 Jul 29;21(1):199. doi: 10.1186/s12931-020-01407-y. — View Citation
Kostikas K, Greulich T, Mackay AJ, Lossi NS, Aalamian-Mattheis M, Nunez X, Pagano VA, Patalano F, Clemens A, Vogelmeier CF. Treatment response in COPD: does FEV1 say it all? A post hoc analysis of the CRYSTAL study. ERJ Open Res. 2019 Feb 25;5(1):00243-2018. doi: 10.1183/23120541.00243-2018. eCollection 2019 Feb. — View Citation
Kostikas K, Mackay AJ, Vogelmeier CF, Frent SM, Gupta P, Banerji D, Patalano F, Pfister PJ, Wedzicha JA. Early Clinically Important Improvement (ECII) and Exacerbation Outcomes in COPD Patients. Int J Chron Obstruct Pulmon Dis. 2020 Jul 28;15:1831-1838. doi: 10.2147/COPD.S247966. eCollection 2020. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Quality of Life assesment | Change in Clinical COPD Questionnaire (CCQ) | 6 months | |
Secondary | Dyspnea assesment | Change in Baseline Dyspnoea Index, BDI at baseline and Transition Dyspnoea Index, TDI between study visits and after 6 months treatment. | 6 months | |
Secondary | COPD Assessment Test | Change in CAT (COPD Assessment Test) between study visits and after 6 months of treatment. | 6 months | |
Secondary | FEV1 % predicted measurement | Change in FEV1% predicted and other spirometric parameters (FEV1, FVC, FEV1/FVC) during study visits and after 6 months of tiotropium treatment | 6 months | |
Secondary | Feeling of Satisfaction with Inhaler (FSI-10) questionnaire | Change in FSI-10 questionnaire for patients satisfaction after 6 months of tiotropium treatment. | 6 months | |
Secondary | Exacerbations | Report of number of median exacerbations that will be appeared during 6 months of tiotropium treatment | 6 months | |
Secondary | Adverse Events | Report the number of Adverse Events during study period | 6 months |
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