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Completed

NCT Number: NCT04249310

Early Intervention Efficacy in COPD

This study aims to evaluate the time to escalation to triple therapy among the Japanese Chronic obstructive pulmonary disease (COPD) patients newly initiating therapy with a combination of Olodaterol and Tiotropium (herein referred to as Tio/Olo) using real world data.

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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

40 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Nara Medical University

Nara, 634-8522, Japan

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

The study cohort will include all patients who initiate Tiotropium/ Olodaterol (Tio/Olo) or Tiotropium (Tio) during the patient selection period.

Exclusion criteria

The following exclusion criteria will then be applied to generate the unmatched cohort:

  • Aged <40 years on cohort entry.
  • Any LAMA, LABA, or ICS maintenance therapy (alone or in combination) during the 180-day baseline period prior to cohort entry for maintenance treatment and duration >30 days, or any prescription within the 30 days prior to cohort entry.
  • Patients without continuous enrolment (days since first inpatient/ outpatient encounter in the data) during the baseline period.
  • No prior diagnosis of COPD [International Classification of Diseases (ICD)-10: J41*, J43*, J44* and doubt (UTAGAIFLG) = 0 (no)]
  • Patients without a second prescription claim of their index medication within 60 days after the cohort entry date.
  • Diagnosis of asthma [ICD-10: J45* and doubt (UTAGAIFLG) = 0 (no)] during the baseline period.
  • Diagnosis of lung cancer [ICD-10: C34*, D02.2, Z80.1, Z85.1 and doubt (UTALAIFLG) = 0 (no)] or lung transplant (Health claim code: 150317670, 150322510, 150322610, 150336510, 150336610, 150336710, 150399270) prior to the cohort entry date using all available data.
  • Patients who initiate both Tio/Olo and Tio simultaneously on the cohort entry date.
  • Any use of triple therapy (LAMA + LABA + ICS) during the baseline period or between the cohort entry date and 1 day prior to the start of follow-up.

Treatment and study plan

Tiotropium/Olodaterol

Drug

Soft Mist Inhaler product

Other names: Spiolto®

Tiotropium

Drug

Soft Mist Inhaler product

Other names: Spiriva®

Primary outcomes

  1. Time to Triple Therapy Initiation

    Time frame: From index date (cohort entry date) until first occurence of event, up to 42 months.

    Time to triple therapy initiation (first event per patient) defined as any fixed dose combination of Long-acting muscarinic antagonists (LAMA) / Long-acting beta agonist (LABA) / Inhaled Corticosteroid (ICS) or any concurrent use for 30 consecutive days of the following:

    • any LAMA/LABA fixed dose combination + any ICS single formulation
    • any LAMA single formulation + any LABA/ICS fixed dose combination
    • any LAMA single formulation + any LABA single formulation + any ICS single formulation.

    Patients will be censored if they had an occurrence of any of the following: outcome (initiation of triple therapy), death, or end of data. The analysis will use an intention-to-treat censoring approach, which does not account for treatment change.

Secondary outcomes

  1. Time to First Moderate or Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbation

    Time frame: From index date until first occurence of event, up to 42 months.

    Time to First Moderate or Severe COPD Exacerbation. Moderate exacerbation is defined as an outpatient visit with a diagnosed code for COPD in any field + a prescription for an oral corticosteroid or an antibiotic for respiratory infections. Severe exacerbations will be defined as a hospitalization with a primary diagnosis for COPD.

    Patients will be censored if they had an occurrence of any of the following: outcome (initiation of triple therapy), death, or end of data. The analysis will use an intention-to-treat censoring approach, which does not account for treatment change.

  2. Number of Moderate or Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbations

    Time frame: From index date until first occurence of event, up to 42 months.

    Number of Moderate or Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbations.

    Moderate exacerbation is defined as an outpatient visit with a diagnosed code for COPD in any field + a prescription for an oral corticosteroid or an antibiotic for respiratory infections. Severe exacerbations will be defined as a hospitalization with a primary diagnosis for COPD.

    Patients will be censored if they had an occurrence of any of the following: outcome (initiation of triple therapy), death, or end of data. The analysis will use an intention-to-treat censoring approach, which does not account for treatment change.

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

Early Intervention Effectiveness of Tiotropium / Olodaterol Compared to Tiotropium in COPD

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jan 30, 2020
Registry last updated
Jun 14, 2022

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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