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OpenTrials
Completed

NCT Number: NCT03979807

A Study Based on Medical Records That Looks at the Duration of Use of Two Types of Inhalers With Different Medicines in Patients With Chronic Obstructive Pulmonary Disease (COPD)

To compare the persistence in using two different medications from the same drug class (LAMA/LABA FDC) which are delivered through different devices, a dry-powder inhalers (DPI) and Soft Mist Inhalers (SMI).

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Key information

Conditions

Pulmonary Disease, Chronic Obstructive Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases

Age range

1 year–40 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Aetion Inc.

New York, 10018, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

-

Exclusion criteria

  • Aged <40 years
  • Enrolment with medical and pharmacy coverage prior to the cohort entry < 180 days
  • Never had COPD diagnosis on the cohort entry date or prior to cohort entry
  • A record for dispensed Olodaterol/Tiotropium Bromide delivered with Respimat inhalator or Umeclidinium/Vilanterol delivered with the Ellipta Inhaler during the 180-day baseline prior to cohort entry
  • Diagnosis of asthma any time prior to cohort entry
  • Diagnosis of lung cancer any time prior to cohort entry
  • Diagnosis of lung transplant any time prior to cohort entry

Treatment and study plan

Olodaterol/Tiotropium Bromide

Drug

(Stiolto®) delivered via Respimat inhaler

Umeclidinium/ Vilanterol

Drug

(Anoro®) delivered via Ellipta Inhaler

Primary outcomes

  1. Rate of Discontinuation of Index Treatment (Olodaterol/Tiotropium Bromide or Umeclidinium/Vilanterol)

    Time frame: From first day after the cohort entry date to the earliest occurence of the outcome (discontinuation or refills), or any censoring criteria (365 days of follow-up without discontinuation, death, disenrollment end of data).

    The primary outcome of interest was discontinuation of index treatment (Olodaterol/Tiotropium Bromide or Umeclidinium/Vilanterol), defined as persistence, (i.e. no refill Claim within 60 days [not including treatment Switch, nor death] after end of supply) during follow-up. Persistence was assessed by calculating rates of discontinuation in the matched cohorts using a 60-day allowable gap. Rates of discontinuation are reported as the number of events divided by the number of Person-years at risk. Addition of another treatment to index treatment did not count as discontinuation.

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

The Role of Inhaler Device in the Treatment Persistence With Dual Bronchodilators in Patients With COPD

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jun 7, 2019
Registry last updated
Nov 15, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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