MedPath

Olodaterol

Generic Name
Olodaterol
Brand Names
Inspiolto Respimat, Stiolto, Striverdi Respimat
Drug Type
Small Molecule
Chemical Formula
C21H26N2O5
CAS Number
868049-49-4
Unique Ingredient Identifier
VD2YSN1AFD
Background

Olodaterol is a novel, long-acting beta2-adrenergic agonist (LABA) that exerts its pharmacological effect by binding and activating beta2-adrenergic receptors located primarily in the lungs. Beta2-adrenergic receptors are membrane-bound receptors that are normally activated by endogenous epinephrine whose signalling, via a downstream L-type calcium channel interaction, mediates smooth muscle relaxation and bronchodilation. Activation of the receptor stimulates an associated G protein which then activates adenylate cyclase, catalyzing the formation of cyclic adenosine monophosphate (cAMP) and protein kinase A (PKA). Elevation of these two molecules induces bronchodilation by relaxation of airway smooth muscles. It is by this mechanism that olodaterol is used for the treatment of chronic obstructive pulmonary disease (COPD) and the progressive airflow obstruction that is characteristic of it. Treatment with bronchodilators helps to mitigate associated symptoms such as shortness of breath, cough, and sputum production. Single doses of olodaterol have been shown to improve forced expiratory volume in 1 sec (FEV1) for 24 h in patients with COPD, allowing once daily dosing. A once-a-day treatment with a LABA has several advantages over short-acting bronchodilators and twice-daily LABAs including improved convenience and compliance and improved airflow over a 24-hour period. Despite similarities in symptoms, olodaterol is not indicated for the treatment of acute exacerbations of COPD or for the treatment of asthma.

Indication

Olodaterol is indicated for use in chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. It is not indicated for the treatment of acute exacerbations of COPD or for the treatment of asthma.

Associated Conditions
Chronic Obstructive Pulmonary Disease (COPD)

Effectiveness of Tiotropium + Olodaterol Versus Inhaled Corticosteroids (ICS) + Long-acting β2-agonists (LABA) Among COPD Patients in Taiwan

Completed
Conditions
Pulmonary Disease, Chronic Obstructive
Interventions
Drug: Inhaled corticosteroids (ICS)
Drug: Long-acting β2-agonists (LABA)
First Posted Date
2022-06-02
Last Posted Date
2024-08-09
Lead Sponsor
Boehringer Ingelheim
Target Recruit Count
17018
Registration Number
NCT05402020
Locations
🇨🇳

National Tawain University Hospital, Taipei, China

Assessment In a Real World Setting of the Effect of Inhaled Steroid-based Triple Therapy Versus the Combination of Tiotropium and Olodaterol on Reducing Chronic Obstructive Pulmonary Disease (COPD) Exacerbations [AIRWISE]

Phase 4
Completed
Conditions
Pulmonary Disease, Chronic Obstructive
Interventions
Drug: ICS (Inhaled Corticosteroid) (Triple therapy)
Drug: LABA (Long-Acting Beta Agonist) (Triple therapy)
Drug: LAMA (Long-Acting Muscarinic Antagonist) (Triple therapy)
First Posted Date
2017-08-29
Last Posted Date
2022-06-14
Lead Sponsor
Boehringer Ingelheim
Target Recruit Count
714
Registration Number
NCT03265145
Locations
🇺🇸

Aureus Medical Group, Inc, Rancho Cucamonga, California, United States

🇺🇸

HealthCare Partners, Commerce, California, United States

🇺🇸

Advanced Research for Health Improvement, LLC, Naples, Florida, United States

and more 83 locations

The ENERGITO® 2 Study Compares 2 Inhaled Medicines for Chronic Obstructive Pulmonary Disease (COPD). One Medicine is a Combination of Tiotropium and Olodaterol (Stiolto®) Taken Using the Respimat® Inhaler and the Other Medicine is a Combination of Fluticasone and Salmeterol Taken Using the Diskus

Phase 4
Completed
Conditions
Pulmonary Disease, Chronic Obstructive
Interventions
First Posted Date
2017-08-07
Last Posted Date
2020-04-16
Lead Sponsor
Boehringer Ingelheim
Target Recruit Count
302
Registration Number
NCT03240575
Locations
🇺🇸

Pulmonary Rsrch Inst of SE MI, Farmington Hills, Michigan, United States

🇺🇸

Spartanburg Medical Research, Spartanburg, South Carolina, United States

🇺🇸

Johns Hopkins Hospital, Baltimore, Maryland, United States

and more 39 locations

Cardiovascular Function in COPD Patients

Phase 4
Completed
Conditions
Pulmonary Disease, Chronic Obstructive
Interventions
First Posted Date
2017-02-16
Last Posted Date
2019-08-16
Lead Sponsor
Boehringer Ingelheim
Target Recruit Count
76
Registration Number
NCT03055988
Locations
🇩🇪

Universitätsklinikum Bonn AöR, Bonn, Germany

🇩🇪

Klinische Forschung Berlin GbR, Berlin, Germany

🇩🇪

Praxis Dr. med. Claus Keller, Frankfurt, Germany

and more 7 locations

Drug Utilization Study for Olodaterol

Completed
Conditions
Pulmonary Disease, Chronic Obstructive
Interventions
First Posted Date
2017-01-25
Last Posted Date
2019-06-27
Lead Sponsor
Boehringer Ingelheim
Target Recruit Count
27606
Registration Number
NCT03030638
Locations
🇫🇷

IMS Health Information solutions, Courbevoie, France

🇳🇱

Pharmo Institute, Utrecht, Netherlands

🇩🇰

Aarhus Universitetshospital Skejby, Aarhus, Denmark

Bioavailability of Tiotropium + Olodaterol Fixed-dose Combination (5 μg/ 5 μg) in Chinese COPD Patients

Phase 1
Completed
Conditions
Pulmonary Disease, Chronic Obstructive
Interventions
First Posted Date
2016-11-21
Last Posted Date
2019-03-29
Lead Sponsor
Boehringer Ingelheim
Target Recruit Count
12
Registration Number
NCT02969317
Locations
🇨🇳

West China Hospital, Chengdu, China

Vahelva Respimat Regulatory Post-marketing Surveillance in Korean Patients With Chronic Obstructive Pulmonary Disease

Completed
Conditions
Pulmonary Disease, Chronic Obstructive
Interventions
First Posted Date
2016-08-12
Last Posted Date
2022-03-28
Lead Sponsor
Boehringer Ingelheim
Target Recruit Count
3223
Registration Number
NCT02864407
Locations
🇰🇷

Chonnam National University Hospital, One Or Multiple Sites, Korea, Republic of

Effect of Tiotropium + Olodaterol on Breathlessness in COPD Patients

Phase 4
Completed
Conditions
Pulmonary Disease, Chronic Obstructive
Interventions
First Posted Date
2016-08-02
Last Posted Date
2019-09-27
Lead Sponsor
Boehringer Ingelheim
Target Recruit Count
106
Registration Number
NCT02853123
Locations
🇧🇪

Hasselt - PRAC Aumann, J-L, Hasselt, Belgium

🇨🇦

McGill University Health Centre (MUHC), Montreal, Quebec, Canada

🇨🇦

McMaster Univ. Medical Centre, Hamilton, Ontario, Canada

and more 10 locations

The Effect of STIOLTO™ RESPIMAT® on Fatigue in Chronic Obstructive Pulmonary Disease

Phase 4
Completed
Conditions
Chronic Obstructive Pulmonary Disease
Interventions
Drug: Placebo Respimat
First Posted Date
2016-07-27
Last Posted Date
2020-08-06
Lead Sponsor
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Target Recruit Count
14
Registration Number
NCT02845752
Locations
🇺🇸

Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center, Torrance, California, United States

Ultra-long Acting Bronchodilator Therapy in Smoking Asthmatics

First Posted Date
2016-02-17
Last Posted Date
2019-06-21
Lead Sponsor
University of Dundee
Target Recruit Count
17
Registration Number
NCT02682862
Locations
🇬🇧

Scottish Centre for Respiratory Research, University of Dundee, Ninewells Hospital and Medical School, Dundee, Scotland, United Kingdom

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