Clinical trial NCT04138758: Comparative Effectiveness and Safety of Tiotropium and Olodaterol in Comparison to LABA/ICS
Official title: Effectiveness and Safety of Maintenance Treatment With Combination of Tiotropium and Olodaterol in Comparison to Maintenance Treatment With a Combination of Inhaled Corticosteroids and Long-acting β2 Agonists in COPD Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COPD
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2019-10-24
Enrollment: 42953
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects with COPD inititated with Tio+Olo in comparison to patients treated with ICS/LABA/LAMA

Brief summary: The primary objective is to compare the effectiveness of maintenance therapy initiation with the combination treatment Tiotropium and Olodaterol (Olo+Tio) compared with LABA/ICS combination in COPD as the time to the first COPD exacerbation.

Secondary objectives are to compare patients treated with Tio+Olo and patients treated with LABA/ ICS combination.


Eligibility criteria: Inclusion Criteria:

1. At least one prescription for Tio+Olo combined inhaler or a LABA/ICS combined inhaler between 1 January 2013 and 31 March 2019.

   1. The first dispensing of either Tio+Olo or LABA/ICS combined inhaler will be defined as the index date.
   2. For the main analyses, only fixed dose combination (FDC) inhalers will be included. Sensitivity analyses will also accept free combinations of LABA/ICS.
2. At least one diagnosis of COPD at any time prior to the index date.
3. At least one year of continuous medical and pharmacy health plan eligibility prior to the index date will be required to allow a baseline period for the covariates and identification of new use of the study drugs.

Exclusion Criteria:

1. To increase the likelihood of a true diagnosis of COPD, we will exclude:

   1. All patients less than 40 years of age on the index date, and
   2. All patients with a diagnosis of asthma in the year prior to the index date
2. To limit the population to those without severe lung compromise outside of COPD, we will exclude individuals with lung cancer, interstitial lung disease, or lung transplant identified at any time prior to the index date
3. To restrict the cohort to new users of Tio+Olo or LABA/ICS, we will exclude any individual with use of either Tio+Olo, LABA/ICS, or LABA/LAMA/ICS combination therapy in free or fixed form for at least one year prior to the index date.

Primary outcomes:
measure: Incidence Rate of Chronic Obstructive Pulmonary Disease (COPD) Exacerbation
timeFrame: From cohort entry (index date) until the occurrence of a hospitalization for COPD (severe exacerbation), ED visit for COPD or prescription of an antibiotic and oral corticosteroid on the same day (moderate exacerbation). Up to one year after cohort entry.
Secondary outcomes:
measure: Incidence Rate of First Hospitalization for Community-acquired Pneumonia
timeFrame: From cohort entry (index date) until the occurrence of first hospitalization for community-acquired pneumonia (serious pneumonia). Up to one year after cohort entry.
measure: Incidence Rate of the First Date of a Pharmacy Dispensing Indicating Escalation (Original Case Definition) to Triple Therapy
timeFrame: From cohort entry (index date) until the escalation, up to one year after cohort entry.
measure: Incidence Rate of the First Date of a Pharmacy Dispensing Indicating Escalation (Alternative Case Definition) to Triple Therapy
timeFrame: From cohort entry (index date) until the escalation, up to one year after cohort entry.
measure: Incidence Rate of Any Element of a Composite Outcome Including Exacerbation, Hospitalization for Pneumonia, or Escalation (Original Case Definition) to Triple Therapy
timeFrame: From cohort entry (index date) until exacerbation, hospitalization (for community-acquired pneumonia) or escalation, up to one year after cohort entry.
measure: Incidence Rate of Any Element of a Composite Outcome Including Exacerbation, Hospitalization for Pneumonia, or Escalation (Alternative Case Definition) to Triple Therapy
timeFrame: From cohort entry (index date) until exacerbation, hospitalization (for community-acquired pneumonia) or escalation, up to one year after cohort entry.
Other outcomes:
Locations:
city: Watertown
country: United States
facility: HealthCore, Inc.
state: Massachusetts
Study officials:
References:
citation: Quint JK, Montonen J, Esposito DB, He X, Koerner L, Wallace L, de la Hoz A, Miravitlles M. Effectiveness and Safety of COPD Maintenance Therapy with Tiotropium/Olodaterol versus LABA/ICS in a US Claims Database. Adv Ther. 2021 May;38(5):2249-2270. doi: 10.1007/s12325-021-01646-5. Epub 2021 Mar 15.