An observational study in COPD, sponsored by Elpen Pharmaceutical Co. Inc.. Not yet recruiting. Open to participants aged 40 Years to 90 Years. Per ClinicalTrials.gov, last updated 2024-02-20.
Sponsored by Elpen Pharmaceutical Co. Inc. · 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.
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, e.g. 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.
5,520 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 856 are open to participants now.
This study's planned enrollment of 500 is above the median of 158 across 1,497 observational studies indexed under Pulmonary Disease, Chronic Obstructive.
Browse Pulmonary Disease, Chronic Obstructive studies →Elpen Pharmaceutical Co. Inc. is the lead sponsor of 45 studies on the registry; 7 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Adult patients patients (≥40 years old) with a diagnosis of Chronic Respiratory Pulmonary Disease (COPD) who were treated with 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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients who are not satisfied with their COPD treatment and will be on additional tiotropium scheme.
Quality of Life assesment
Change in Clinical COPD Questionnaire (CCQ)
Time frame: 6 months
Dyspnea assesment
Change in Baseline Dyspnoea Index, BDI at baseline and Transition Dyspnoea Index, TDI between study visits and after 6 months treatment.
Time frame: 6 months
COPD Assessment Test
Change in CAT (COPD Assessment Test) between study visits and after 6 months of treatment.
Time frame: 6 months
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
Time frame: 6 months
Feeling of Satisfaction with Inhaler (FSI-10) questionnaire
Change in FSI-10 questionnaire for patients satisfaction after 6 months of tiotropium treatment.
Time frame: 6 months
Exacerbations
Report of number of median exacerbations that will be appeared during 6 months of tiotropium treatment
Time frame: 6 months
Adverse Events
Report the number of Adverse Events during study period
Time frame: 6 months
No study locations are listed for this record.
Plan to share: No
Start is estimated for Mar 2024; primary completion for Mar 2025, 12 months later.
Of 120 industry-sponsored observational studies under Pulmonary Disease, Chronic Obstructive, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 37. This study's planned 12 months is below that.
Counting every sponsor, half of 586 studies reached it within 26 months; a quarter within 14 and three quarters within 58.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.
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Pulmonary Disease, Chronic Obstructive →
Elpen Pharmaceutical Co. Inc. →