A Study Using US Medical and Pharmacy Claim Records to Compare the Resource Use, Cost, and Outcomes of People With COPD Who Take Either Tiotropium + Olodaterol or Fluticasone + Umeclidinium + Vilanterol

Boehringer Ingelheim

Status: Completed

Conditions: Pulmonary Disease, Chronic Obstructive

Treatments: Drug: Tiotropium Bromide/Olodaterol; Device: Stiolto Respimat; Device: Trelegy Ellipta; Drug: Furoate/Umeclidinium/Vilanterol

Study type: Observational

Funder types: Industry

Identifiers

NCT05127304

1237-0113

Details and patient eligibility

About

The purpose of this study is to estimate disease-related and all-cause burden and clinical outcomes of interest following initiation of chronic obstructive lung disease (COPD) maintenance therapy with Tiotropium Bromide/Olodaterol (TIO/OLO) or Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI).

Enrollment: 11,316 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• ≥30 consecutive days with Tiotropium Bromide/Olodaterol (TIO/OLO) or Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI) initiated during the patient identification period of 01 June 2015 to 30 November 2019. The index date will be the date of the TIO/OLO or FF/UMEC/VI pharmacy claim that starts the ≥30 consecutive days with the medication.
• >1 facility claim with a diagnosis of chronic obstructive lung disease (COPD) in the primary position or ≥2 professional claims with a diagnosis code for COPD in any position on separate dates of service during the study period
• ≥40 years of age as of the year of the index date
• Continuous enrollment with medical and pharmacy coverage for 12 months prior to and including the index date (baseline period)
• Continuous enrollment with medical and pharmacy coverage for ≥30 days following the index date and without discontinuation of the index medication or switch to a non-index regimen (follow-up period); discontinuation and switch as defined in the protocol.

Exclusion criteria

• ≥2 medical claims with a diagnosis code for asthma, cystic fibrosis, lung cancer, or interstitial lung disease in any position on separate dates of service during the baseline period

• Pharmacy claims for both TIO/OLO and FF/UMEC/VI on the index date

• A pharmacy claim for any non-index COPD maintenance medication on the index date, defined as: long-acting muscarinic antagonists (LAMA) monotherapy; long-acting beta2 agonists (LABA) monotherapy; inhaled corticosteroids (ICS) monotherapy; fixed-dose combination (FDC) ICS/LABA, or FDC LAMA/LABA

• Free or fixed dose LAMA+LABA maintenance therapy defined as ≥7 consecutive days of overlapping days' supply with a LAMA and LABA during a 6-month pre-index period, excluding the index date

  -- Flags will be created to identify patients excluded for baseline LAMA/LABA use overall and specifically for each FDC LAMA/LABA medication

• Free or fixed dose triple therapy (TT) defined as ≥7 consecutive days of overlapping days' supply with an ICS, LABA, and LAMA during a 6-month pre-index period, excluding the index date

• ≥1 medical claim with a procedure code for lung volume reduction during the study period

• Unknown age, gender, or business line, or unknown/other geographic region

Trial design

11,316 participants in 2 patient groups

Tiotropium bromide/Olodaterol (TIO/OLO)

Description:

Chronic Obstructive Pulmonary Disease (COPD) patients with ≥30 consecutive days with TIO/OLO initiated during the patient identification period of 01 June 2015 to 30 November 2019 and ≥40 years of age as of the year of the index date. The index date was the date of the TIO/OLO pharmacy claim that started the ≥30 consecutive days with the medication.

Treatment:

Drug: Tiotropium Bromide/Olodaterol

Device: Stiolto Respimat

Fluticasone furoate/Umeclidinium/Vilanterol (FF/UMEC/VI)

Description:

Chronic Obstructive Pulmonary Disease (COPD) patients with ≥30 consecutive days with FF/UMEC/VI initiated during the patient identification period of 01 June 2015 to 30 November 2019 and ≥40 years of age as of the year of the index date. The index date was the date of the FF/UMEC/VI pharmacy claim that started the ≥30 consecutive days with the medication.

Treatment:

Device: Trelegy Ellipta

Drug: Furoate/Umeclidinium/Vilanterol