Newswires
Newswires RSS Get our newsletter
Order Prints
Newswires No comments

Effectiveness of Maintenance Treatment With Tiotropium + Olodaterol in Comparison to Inhaled Corticosteroids + Longacting b2 Agonists in COPD Patients in Taiwan: a Noninterventional Study Based on the Taiwan National Health Insurance (NHI) Data: Lung Diseases and Conditions – Chronic Obstructive Pulmonary Disease

2022 JUN 21 (NewsRx) -- By a News Reporter-Staff News Editor at Insurance Daily News -- Staff editors report on the newly launched clinical trial, NCT05402020, which has the following summary description: “The real world study aims to assess effectiveness and safety profile between tiotropium/olodaterol (Tio/Olo) and inhaled corticosteroids(ICS) / Long-acting b2-agonists (LABA) in patients with chronic obstructive pulmonary disease (COPD) in Taiwan. The data used in this study will come from the Taiwan National Health Insurance (NHI) claims data between 2014 and 2019.”

As a matter of record, on June 3, 2022, NewsRx staff editors report that the available information provided by Boehringer Ingelheim on this trial include:

Tracking Information

Trial Identifier NCT05402020
First Submitted Date May 30, 2022
First Posted Date June 2, 2022
Results First Submitted Date Not Provided
Results First Posted Date Not Provided
Last Update Submitted Date May 30, 2022
Last Update Posted Date June 2, 2022
Primary Completion Date July 30, 2022
Start Date June 15, 2022
Current Primary Outcome Measures •Time to the first moderate or severe COPD exacerbations after index date [ Time Frame: Up to 5 years. ]
Current Secondary Outcome Measures •Time to triple therapy escalation after index date [ Time Frame: Up to 5 years. ]
•Incidence rate of triple therapy initiation (first event per patient) [ Time Frame: Up to 5 years. ]
•Time to the first hospitalization for community-acquired pneumonia after entry [ Time Frame: Up to 5 years. ]
•Annualized rate of prescriptions of rescue medications after the index date [ Time Frame: Up to 5 years. ] -- Annualized rate=number of prescriptions/total patient year at risk. Total patient year at risk=number of prescriptions per patient year.
•Annualized rate of moderate or severe COPD exacerbation after the index date [ Time Frame: Up to 5 years. ] -- Annualized rate=number of moderate or severe COPD exacerbations/total patient year at risk. Total patient year at risk = number of exacerbations per patient year.
Other Outcome Measures Not Provided
Change History Complete list of historical revisions of study NCT05402020

Descriptive Information

Brief Title Effectiveness of Tiotropium + Olodaterol Versus Inhaled Corticosteroids (ICS) + Long-acting b2-agonists (LABA) Among COPD Patients in Taiwan
Official Title Effectiveness of Maintenance Treatment With Tiotropium + Olodaterol in Comparison to Inhaled Corticosteroids + Longacting b2 Agonists in COPD Patients in Taiwan: a Noninterventional Study Based on the Taiwan National Health Insurance (NHI) Data
Brief Summary The real world study aims to assess effectiveness and safety profile between tiotropium/olodaterol (Tio/Olo) and inhaled corticosteroids(ICS) / Long-acting b2-agonists (LABA) in patients with chronic obstructive pulmonary disease (COPD) in Taiwan. The data used in this study will come from the Taiwan National Health Insurance (NHI) claims data between 2014 and 2019.
Detailed Description Not Provided
Study Type Observational
Study Phase Not Provided
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Condition Pulmonary Disease, Chronic Obstructive
Intervention •Drug: Tiotropium (Tio)
Tiotropium (Tio)
•Drug: Inhaled corticosteroids (ICS)
Inhaled corticosteroids (ICS)
•Drug: Olodaterol (Olo)
Olodaterol (Olo)
•Drug: Long-acting b2-agonists (LABA)
Long-acting b2-agonists (LABA)
•Device: Combined Inhaler
Combined Inhaler
Study Arms •ICS/LABA cohort
COPD patients included in the NHI database between 2014 and 2019 and who received inhaled corticosteroids/ Long-acting ß2-agonists (ICS/LABA).
Interventions:
⚬Drug: Inhaled corticosteroids (ICS)
⚬Drug: Long-acting b2-agonists (LABA)
⚬Device: Combined Inhaler
•Tio/Olo cohort
COPD patients included in the NHI database between 2014 and 2019 and who received Tiotropium/olodaterol (Tio/Olo).
Interventions:
⚬Drug: Tiotropium (Tio)
⚬Drug: Olodaterol (Olo)
⚬Device: Combined Inhaler

Recruitment Information

Recruitment Status Not yet recruiting
Estimated Enrollment 4978
Estimated Completion Date July 30, 2022
Primary Completion Date July 30, 2022 (Final data collection date for primary outcome measure)
Eligibility Inclusion Criteria: At least one prescriptions for Tiotropium/Olodaterol (Tio/Olo) combined inhaler or Long-acting ß2 agonist / Inhaled Corticosteroids (LABA/ICS) combined inhaler between 1st January 2014 and 31st December 2019. The first dispensing of either Tio/Olo or LABA/ICS combined inhaler will be defined as the index date; For the main analyses, only fixed dose combination (FDC) inhalers will be included. Aged ≥ 40 years on the index date (in a sensitivity analysis we will only include patients aged ≥ 55 years on the index date); At least one diagnosis of chronic obstructive pulmonary disease (COPD) at any time prior to or on the index date; At least one year of continuous medical and health insurance plan prior to the index date will be required to allow for a look-back period for the covariates and identification of new use of the study drugs; At least one record in the health insurance system database Exclusion Criteria: Any use of Tio/Olo, ICS/LABA, or ICS/LABA/ Long-acting muscarinic antagonists (LAMA) in free or fixed form for one year prior to the index date; Individuals with asthma, allergic rhinitis, lung cancer, interstitial lung disease, or lung transplant identified at any time prior to the index date (in a sensitivity analysis we will include patients with asthma);
Sex/Gender Sexes Eligible for Study: All
Ages 40 years and older
Accepts Healthy Volunteers No
Contacts Primary contact: Boehringer Ingelheim, 1-800-243-0127, [email protected]
Listed Location Countries Not Provided
Removed Location Countries

Administrative Information

NCT Number NCT05402020
Other Study ID Numbers 1237-0110
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Studies a U.S. FDA-Regulated Drug Product: Yes
Studies a U.S. FDA-Regulated Device Product: Yes
Plan to Share Data No
Plan to Share Data (IPD) Description Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization). For more details refer to: https://www.mystudywindow.com/msw/datatransparency
Responsible Party Boehringer Ingelheim
Collaborators Not Provided
Investigators Not Provided
Information Provided By Boehringer Ingelheim
Verification Date May 2022

(Our reports deliver fact-based news of research and discoveries from around the world.)

Advisor News

More Advisor News

Annuity News

More Annuity News

Health/Employee Benefits News

More Health/Employee Benefits News

Life Insurance News

More Life Insurance News