Who is sponsoring NCT03030638?

NCT03030638 is sponsored by Boehringer Ingelheim.

What drugs are being tested in NCT03030638?

Interventions in NCT03030638: Olodaterol, Indacaterol.

What condition does NCT03030638 study?

NCT03030638 studies Pulmonary Disease, Chronic Obstructive.

Is NCT03030638 still recruiting?

NCT03030638 is currently completed. Last updated 27 June 2019.

Are results published for NCT03030638?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2019-06-27 · How we verify

NCT03030638

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Drug Utilization Study for Olodaterol

Completed Results posted Last updated 27 June 2019

What this trial tests

trial testing Olodaterol in Pulmonary Disease, Chronic Obstructive in 27,606 participants. Completed in 31 March 2018.

Timeline

8 February 2017

Primary endpoint
31 March 2018

31 March 2018

Quick facts

Lead sponsor	Boehringer Ingelheim
Status	Completed
Study type	OBSERVATIONAL
Enrollment	27,606
Start date	8 February 2017
Primary completion	31 March 2018
Estimated completion	31 March 2018
Sites	3 locations across Denmark, Netherlands, France

Drugs / interventions tested

Olodaterol (OLODATEROL) — full drug profile →
Indacaterol (INDACATEROL) — full drug profile →

Conditions studied

Pulmonary Disease, Chronic Obstructive — all drugs for Pulmonary Disease, Chronic Obstructive →

Sponsor

Boehringer Ingelheim — full company profile →

Who can join

28 Days and older, any sex, with Pulmonary Disease, Chronic Obstructive. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Percentage of Off-label Use of Olodaterol Among New Users Primary · 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.

Potential off-label

Group	Value	95% CI
Olodaterol - PHARMO Overall	48.6
Olodaterol - PHARMO-GP	19.6
Olodaterol - National Health Databases, Denmark	30.3
Olodaterol - IMS RWE LPD General Practitioner (GP) Panel	33.9
Olodaterol - IMS RWE LPD Pulmonologist Panel	17.3

Off-label

Group	Value	95% CI
Olodaterol - PHARMO Overall	3.5
Olodaterol - PHARMO-GP	6.2
Olodaterol - National Health Databases, Denmark	4.4
Olodaterol - IMS RWE LPD General Practitioner (GP) Panel	12.4
Olodaterol - IMS RWE LPD Pulmonologist Panel	4.9

Percentage of Off-label Use of Indacaterol Among New Users Secondary · 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.

Potential off-label

Group	Value	95% CI
Indacaterol - PHARMO Overall	61.1
Indacaterol - PHARMO-GP	29.2
Indacaterol - National Health Databases, Denmark	66.6
Indacaterol - IMS RWE LPD GP Panel	34.9
Indacaterol - IMS RWE LPD Pulmonologist Panel	20.5

Off-label

Group	Value	95% CI
Indacaterol - PHARMO Overall	3.5
Indacaterol - PHARMO-GP	6.8
Indacaterol - National Health Databases, Denmark	4.6
Indacaterol - IMS RWE LPD GP Panel	11.9
Indacaterol - IMS RWE LPD Pulmonologist Panel	9.4

Baseline Characteristics of New Users of Indacaterol: Age Secondary · Baseline

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

Group	Value	95% CI
Indacaterol - PHARMO Overall	67	59.0 – 75.0
Indacaterol - National Health Databases, Denmark	69	61.2 – 76.5
Indacaterol - IMS RWE LPD GP Panel	63	53.0 – 73.0
Indacaterol - IMS RWE LPD Pulmonologist Panel	68	59.0 – 78.0

Baseline Characteristics of New Users of Olodaterol: Age Primary · Baseline

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

Group	Value	95% CI
Olodaterol - PHARMO Overall	68	60.0 – 75.0
Olodaterol - National Health Databases, Denmark	71	64.0 – 78.5
Olodaterol - IMS RWE LPD General Practitioner (GP) Panel	63	53.0 – 72.0
Olodaterol - IMS RWE LPD Pulmonologist Panel	67	59.0 – 75.0

Baseline Characteristics of New Users of Olodaterol: Gender Primary · Baseline

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

Group	Value	95% CI
Olodaterol - PHARMO Overall	702
Olodaterol - National Health Databases, Denmark	977
Olodaterol - IMS RWE LPD General Practitioner (GP) Panel	322
Olodaterol - IMS RWE LPD Pulmonologist Panel	129
Olodaterol - PHARMO Overall	684
Olodaterol - National Health Databases, Denmark	735
Olodaterol - IMS RWE LPD General Practitioner (GP) Panel	374
Olodaterol - IMS RWE LPD Pulmonologist Panel	235

Baseline Characteristics of New Users of Indacaterol: Gender Secondary · Baseline

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

Group	Value	95% CI
Indacaterol - PHARMO Overall	887
Indacaterol - National Health Databases, Denmark	3324
Indacaterol - IMS RWE LPD GP Panel	696
Indacaterol - IMS RWE LPD Pulmonologist Panel	42
Indacaterol - PHARMO Overall	954
Indacaterol - National Health Databases, Denmark	3082
Indacaterol - IMS RWE LPD GP Panel	896
Indacaterol - IMS RWE LPD Pulmonologist Panel	85

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other trials of Olodaterol

Trials testing the same drug.

NCT03240575 — The ENERGITO® 2 Study Compares 2 Inhaled Medicines for Chronic Obstructive Pulmonary Disease (COPD). One Medicine is a C · Phase 4 · completed
NCT03055988 — Cardiovascular Function in COPD Patients · Phase 4 · completed
NCT02969317 — Bioavailability of Tiotropium + Olodaterol Fixed-dose Combination (5 μg/ 5 μg) in Chinese COPD Patients · Phase 1 · completed
NCT02853123 — Effect of Tiotropium + Olodaterol on Breathlessness in COPD Patients · Phase 4 · completed
NCT02683109 — Fixed Dose Combination Versus Free Combination of Tiotropium and Olodaterol in COPD · Phase 4 · completed

Other recruiting trials for Pulmonary Disease, Chronic Obstructive

Currently open trials in the same condition.

NCT07177339 — eValuating the Efficacy and Safety of InitiatinG depemokImab earLy therApy iN Chronic Obstructive Pulmonary Disorder (CO · Phase 3 · recruiting
NCT06961214 — Depemokimab as an Extended treatmeNt Duration Biologic in Adults With Chronic Obstructive Pulmonary Disease (COPD) and T · Phase 3 · recruiting
NCT06959095 — Depemokimab as an Extended treatmeNt Duration Biologic in Adults With Chronic Obstructive Pulmonary Disease (COPD) and T · Phase 3 · recruiting
NCT06890208 — Chronical Illness-related Limitations of the Ability to Cope With Rising Temperatures, Third Wave · recruiting
NCT06712563 — Pooled Analysis of Single-arm Studies of Budesonide/Glycopyrronium/Formoterol (BGF) in Routine Care Setting · recruiting

Other Boehringer Ingelheim trials

Trials by the same sponsor.

NCT07044700 — Real-world Comparative Effectiveness and Safety of Jardiance in Chinese Patients With Heart Failure of Reduced Ejection · not yet recruiting
NCT07047508 — Real-world Study to Describe the Effectiveness and Safety Outcomes of Jardiance in Chinese Patients With Heart Failure a · not yet recruiting
NCT07366034 — A Study to Find Out How Nerandomilast is Tolerated, Handled by the Body, and if it Helps Children and Adolescents With I · Phase 3 · not yet recruiting
NCT07531628 — A Study to Test How Verducatib is Taken up in the Body of Healthy Chinese Participants · Phase 1 · not yet recruiting
NCT07497087 — A Study to Test Whether Nerandomilast Helps People With Systemic Sclerosis · Phase 3 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03030638 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Boehringer Ingelheim
Last refreshed: 27 June 2019

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03030638.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing