Indacaterol

Generic Name
Indacaterol
Brand Names
Hirobriz, Onbrez, Ultibro, Oslif Breezhaler, Hirobriz Breezhaler, Onbrez Breezhaler
Drug Type
Small Molecule
Chemical Formula
C24H28N2O3
CAS Number
312753-06-3
Unique Ingredient Identifier
8OR09251MQ
Background

Indacaterol is a novel, ultra-long-acting, rapid onset β(2)-adrenoceptor agonist developed for Novartis for the once-daily management of asthma and chronic obstructive pulmonary disease. It was approved by the European Medicines Agency (EMA) on 30 November 2009 and by the FDA on 1 July 2011. It is marketed in Europe as Onbrez and in America as Arcapta Neohal...

Indication

For the long term, once-daily-dosing maintenance of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.

Associated Conditions
Asthma, Chronic Obstructive Pulmonary Disease (COPD)
Associated Therapies
Maintenances

Efficacy of Indacaterol 150 µg Versus Formoterol

First Posted Date
2011-06-21
Last Posted Date
2017-04-20
Lead Sponsor
Novartis Pharmaceuticals
Registration Number
NCT01377428

To Determine the Relationship Between Baseline Reversibility and the Efficacy of Indacaterol

First Posted Date
2011-01-07
Last Posted Date
2016-11-16
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
625
Registration Number
NCT01272362
Locations
🇫🇷

Novartis Investigative Site, Villefranche sur Saone, France

12-week Open-label Evaluation of Efficacy and Safety of Indacaterol

First Posted Date
2010-11-02
Last Posted Date
2013-11-19
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
90
Registration Number
NCT01232894
Locations
🇮🇱

Novartis Investigative Site, Tel Aviv, Israel

Efficacy, Safety and Pharmacokinetics of Different Regimens of Indacaterol

First Posted Date
2010-07-05
Last Posted Date
2011-08-17
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
191
Registration Number
NCT01156844
Locations
🇺🇸

Novartis Investigator Site, Oklahoma City, Oklahoma, United States

🇬🇧

Novartis Investigative Site, Merthyr Tydfil, United Kingdom

Efficacy and Safety of Different Doses of Indacaterol in Chronic Obstructive Pulmonary Disease (COPD)

First Posted Date
2010-03-18
Last Posted Date
2011-08-19
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
552
Registration Number
NCT01089127
Locations
🇺🇸

Novartis Investigative Site, Richmond, Virginia, United States

🇺🇸

Novartis Investigator Site, Tacoma, Washington, United States

🇺🇸

Novartis Investigative site, Newport News, Virginia, United States

Efficacy and Safety of Different Doses of Indacaterol

First Posted Date
2010-03-02
Last Posted Date
2011-08-19
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
511
Registration Number
NCT01079130
Locations
🇺🇸

Novartis Investigative site, North Charleston, South Carolina, United States

🇺🇸

Novartis Investigator Site, Seattle, Washington, United States

🇺🇸

Novartis Investigative Site, Charleston, South Carolina, United States

Comparison of Efficacy of Indacaterol Versus Placebo Over 12 Weeks

First Posted Date
2010-02-15
Last Posted Date
2011-08-19
Lead Sponsor
Novartis
Target Recruit Count
318
Registration Number
NCT01068600
Locations
🇺🇸

Novartis Investigator Site, McKinney, Texas, United States

🇺🇸

Novartis Investigative Site, Richmond, Virginia, United States

🇺🇸

Novartis Investigative site, Greenville, South Carolina, United States

Effect of Indacaterol on Inspiratory Capacity (IC)

First Posted Date
2009-11-13
Last Posted Date
2016-02-17
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
173
Registration Number
NCT01012765
Locations
🇩🇪

Novartis Investigative site, Leipzig, Germany

🇩🇪

Novartis Investigative Site, Zerbst, Germany

🇩🇪

Novartis Investigator Site, Witten, Germany

Safety, Tolerability and Efficacy of Indacaterol in Patients With Moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD)

Phase 3
Completed
Conditions
Interventions
First Posted Date
2008-05-15
Last Posted Date
2011-08-22
Lead Sponsor
Novartis
Target Recruit Count
415
Registration Number
NCT00677807
Locations
🇹🇷

Novartis Investigative Site, Kartal/Istanbul, Turkey

🇺🇸

Novartis Investigative SIte, Fullerton, California, United States

🇹🇷

Novartis Investigator Site, Yenisehir/Izmir, Turkey

and more 2 locations

Study to Determine the Onset of Action of Indacaterol in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)

First Posted Date
2008-04-30
Last Posted Date
2011-09-12
Lead Sponsor
Novartis
Target Recruit Count
89
Registration Number
NCT00669617
Locations
🇭🇺

Novartis Investigative site, Deszk, Hungary

🇭🇺

Novartis Investigative Site, Nyiregyhaza, Hungary

🇩🇪

Novartis Investigator Site, Potsdam, Germany

© Copyright 2024. All Rights Reserved by MedPath