Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Drug Utilization Study for Olodaterol

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03030638
Recruitment Status : Completed
First Posted : January 25, 2017
Results First Posted : June 27, 2019
Last Update Posted : June 27, 2019
Sponsor:
Collaborator:
RTI health solutions, US
Information provided by (Responsible Party):
Boehringer Ingelheim

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.

Condition or disease Intervention/treatment
Pulmonary Disease, Chronic Obstructive Drug: Olodaterol Drug: Indacaterol

Detailed Description:
Boehringer Ingelheim GmbH (BI) developed olodaterol, an inhaled long-acting beta2-agonist (LABA), for the indication of chronic obstructive pulmonary disease (COPD). Because the use of LABAs has been associated with increased morbidity and mortality in patients with asthma, the health authorities requested the conduct of a post-approval drug utilisation study to assess potential off-label use of olodaterol in asthma and to characterise the use of olodaterol in clinical practice. The single agent indacaterol, the only other marketed LABA authorised in clinical practice for COPD but not for asthma, will also be assessed. Study objectives include the following: (1) Quantify the frequency of off-label use of olodaterol and indacaterol among new users of these medications; and (2) Describe the baseline characteristics of new users of olodaterol and indacaterol. This cross-sectional study will use information among new users of olodaterol or indacaterol collected in the following healthcare databases: the PHARMO Database Network in the Netherlands, the National Registers in Denmark, and the IMS Health Information Solutions (IMS) Real-World Evidence (RWE) Longitudinal Patient Database (LPD) in France. The source population is all patients enrolled in the selected study databases at the date olodaterol became available in each database's country. The study groups are those patients from the source population who receive a first dispensing for single-agent formulations of olodaterol for the primary objective or indacaterol for the secondary objective and have at least 12 months of continuous enrolment in the study databases. The study will describe the number and proportion of new users by indication and potential off-label use and according to medical history and use of co-medications.

Layout table for study information
Study Type : Observational
Actual Enrollment : 27606 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Drug Utilization Study for Olodaterol
Actual Study Start Date : February 8, 2017
Actual Primary Completion Date : March 31, 2018
Actual Study Completion Date : March 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD

Group/Cohort Intervention/treatment
Olodaterol
Patients initiating Olodaterol for the first time
Drug: Olodaterol
Drug
Other Name: STRIVERDI

Indacaterol
Patients initiating Indacaterol for the first time
Drug: Indacaterol
Drug




Primary Outcome Measures :
  1. Percentage of Off-label Use of Olodaterol Among New Users [ Time Frame: 01March2014 to 30November2017 up to 30 days after index date, up to 1370 days. ]
    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.

  2. Baseline Characteristics of New Users of Olodaterol: Age [ Time Frame: Baseline ]
    Baseline characteristics of patients in treatment group by data source: Age

  3. Baseline Characteristics of New Users of Olodaterol: Gender [ Time Frame: Baseline ]
    Baseline characteristics of patients in treatment group by data source: Gender


Secondary Outcome Measures :
  1. Percentage of Off-label Use of Indacaterol Among New Users [ Time Frame: 01March2014 to 30November2017 up to 30 days after index date, up to 1370 days. ]
    Percentage of off-label use of Indacaterol among new users of this medication. Potential off-label are the patients, aged 18 years or older with no recorded 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.

  2. Baseline Characteristics of New Users of Indacaterol: Age [ Time Frame: Baseline ]
    Baseline characteristics of patients in treatment group by data source: Age

  3. Baseline Characteristics of New Users of Indacaterol: Gender [ Time Frame: Baseline ]
    Baseline characteristics of patients in treatment group by data source: Gender



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability 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.
Criteria

Inclusion criteria:

  • 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

Exclusion criteria:

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03030638


Locations
Layout table for location information
Denmark
Aarhus Universitetshospital Skejby
Aarhus, Denmark
France
IMS Health Information solutions
Courbevoie, France
Netherlands
Pharmo Institute
Utrecht, Netherlands
Sponsors and Collaborators
Boehringer Ingelheim
RTI health solutions, US
Investigators
Layout table for investigator information
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  Study Documents (Full-Text)

Documents provided by Boehringer Ingelheim:
Study Protocol  [PDF] February 13, 2014
Statistical Analysis Plan  [PDF] January 16, 2017

Additional Information:
Layout table for additonal information
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT03030638    
Other Study ID Numbers: 1222.53
First Posted: January 25, 2017    Key Record Dates
Results First Posted: June 27, 2019
Last Update Posted: June 27, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Pulmonary Disease, Chronic Obstructive
Lung Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Olodaterol
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents