NCT03030638

Brief Summary

This study aims to characterise the use of single-agent olodaterol and single-agent indacaterol, the only marketed long-acting beta2-agonist (LABA)s authorised for chronic obstructive pulmonary disease (COPD), but not for asthma, in clinical practice.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27,606

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2017

Geographic Reach
3 countries

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 23, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 25, 2017

Completed
14 days until next milestone

Study Start

First participant enrolled

February 8, 2017

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2018

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

June 27, 2019

Completed
Last Updated

June 27, 2019

Status Verified

March 1, 2019

Enrollment Period

1.1 years

First QC Date

January 23, 2017

Results QC Date

March 29, 2019

Last Update Submit

March 29, 2019

Conditions

Pulmonary Disease, Chronic Obstructive

Outcome Measures

Primary Outcomes (3)

  • Percentage of Off-label Use of Olodaterol Among New Users

    Percentage of off-label use of olodaterol among new users of this medication. Potential off-label are the patients, aged 18 years or older with no recorded Chronic Obstructive Pulmonary Disease (COPD) diagnosis and no asthma diagnosis. Off-label are the patients, aged 17 years or younger or patients aged 18 years or older with no recorded COPD diagnosis but with a diagnosis of asthma. Index date is defined as the date an eligible patient receives the first dispensing of olodaterol or indacaterol during the study period.

    01March2014 to 30November2017 up to 30 days after index date, up to 1370 days.

  • Baseline Characteristics of New Users of Olodaterol: Age

    Baseline characteristics of patients in treatment group by data source: Age

    Baseline

  • Baseline Characteristics of New Users of Olodaterol: Gender

    Baseline characteristics of patients in treatment group by data source: Gender

    Baseline

Secondary Outcomes (3)

  • Percentage of Off-label Use of Indacaterol Among New Users

    01March2014 to 30November2017 up to 30 days after index date, up to 1370 days.

  • Baseline Characteristics of New Users of Indacaterol: Age

    Baseline

  • Baseline Characteristics of New Users of Indacaterol: Gender

    Baseline

Study Arms (2)

Olodaterol

Patients initiating Olodaterol for the first time

Drug: Olodaterol

Indacaterol

Patients initiating Indacaterol for the first time

Drug: Indacaterol

Interventions

OlodaterolDRUG

Drug

Also known as: STRIVERDI
Olodaterol
IndacaterolDRUG

Drug

Indacaterol

Eligibility Criteria

Age28 Days+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The study source population includes all patients enrolled in the selected study databases at the date both olodaterol and indacaterol are available in each database's country. The study is planned to be conducted in the following databases: the PHARMO Database Network in the Netherlands, the National Registers in Denmark, and the Real-World Evidence (RWE) Longitudinal Patient Database (LPD) in France.

You may qualify if:

  • receive a first prescription/dispensing for single-agent formulations of olodaterol or indacaterol during the study period (no prescriptions/dispensings ever before)
  • patients must have at least 12 consecutive months of enrolment in the database before the index date

You may not qualify if:

  • \- Individuals with missing or implausible values for age or sex will be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Aarhus Universitetshospital Skejby

Aarhus, Denmark

Location

IMS Health Information solutions

Courbevoie, France

Location

Pharmo Institute

Utrecht, Netherlands

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

olodaterolindacaterol

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Boehringer Ingelheim, Call Center
Organization
Boehringer Ingelheim
clintriage.rdg@boehringer-ingelheim.com
1-800-243-0127

Study Officials

  • Boehringer Ingelheim

    Boehringer Ingelheim

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 23, 2017

First Posted

January 25, 2017

Study Start

February 8, 2017

Primary Completion

March 31, 2018

Study Completion

March 31, 2018

Last Updated

June 27, 2019

Results First Posted

June 27, 2019

Record last verified: 2019-03

Locations

DK(1)NL(1)FR(1)