Early Intervention Efficacy in COPD

Pulmonary Disease, Chronic Obstructive Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04249310
• Other study ID #: 1237-0100
• Status: Completed
• Start date: March 27, 2020
• Est. completion date: August 12, 2020

Study information

• Verified date: May 2022
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6788
• Est. completion date: August 12, 2020
• Est. primary completion date: August 12, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• Tiotropium/Olodaterol
Soft Mist Inhaler product
• Tiotropium
Soft Mist Inhaler product

Locations

Country	Name	City	State
Japan	Nara Medical University	Nara

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to Triple Therapy Initiation	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.	From index date (cohort entry date) until first occurence of event, up to 42 months.
Secondary	Time to First Moderate or Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbation	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.	From index date until first occurence of event, up to 42 months.
Secondary	Number of Moderate or Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbations	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.	From index date until first occurence of event, up to 42 months.

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