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
Study of Indacaterol Dosed in the Evening in Patients With Chronic Obstructive Pulmonary Disease (COPD)
- Conditions
- Interventions
- First Posted Date
- 2008-02-14
- Last Posted Date
- 2011-08-17
- Lead Sponsor
- Novartis
- Target Recruit Count
- 96
- Registration Number
- NCT00615030
- Locations
- 🇪🇸
Novartis Investigative Site, Barcelona, Spain
A Crossover Study to Determine the Effect on Lung Function of Indacaterol in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD), Using Tiotropium as an Active Control
- Conditions
- Interventions
- First Posted Date
- 2008-02-14
- Last Posted Date
- 2011-08-17
- Lead Sponsor
- Novartis
- Target Recruit Count
- 169
- Registration Number
- NCT00615459
- Locations
- 🇪🇸
Novartis Investigator Site, Orense, Spain
🇪🇸Novartis Investigative Site, Madrid, Spain
🇪🇸Novartis Investigative site, Alicante, Spain
Efficacy and Safety of QVA149 in Patients With Chronic Obstructive Pulmonary Disease (COPD)
- Conditions
- Interventions
- First Posted Date
- 2007-12-11
- Last Posted Date
- 2018-07-26
- Lead Sponsor
- Novartis Pharmaceuticals
- Target Recruit Count
- 154
- Registration Number
- NCT00570778
- Locations
- 🇳🇱
Novartis Investigator Site, Veldhoven, Netherlands
🇳🇱Novartis Investigator site, Eindhoven, Netherlands
🇳🇱Novartis investigator site, Heerlen, Netherlands
Safety and Tolerability of QVA149 (Indacaterol/Glycopyrrolate) Compared to Placebo and to Indacaterol in Patients With Moderate to Severe Stable Chronic Obstructive Pulmonary Disease (COPD)
- Conditions
- Interventions
- First Posted Date
- 2007-11-14
- Last Posted Date
- 2012-11-30
- Lead Sponsor
- Novartis
- Target Recruit Count
- 257
- Registration Number
- NCT00558285
- Locations
- 🇹🇷
Novartis Investigator Site, Izmir, Turkey
🇫🇷Novartis investigator site, Martigues, France
🇮🇹Novartis Investigator site, Modena, Italy
A Dose Ranging Trial of 4 Doses of Indacaterol Delivered Via the TWISTHALER® Device in Patients With Chronic Obstructive Pulmonary Disease (COPD)
- Conditions
- Interventions
- First Posted Date
- 2007-11-14
- Last Posted Date
- 2013-01-18
- Lead Sponsor
- Novartis
- Target Recruit Count
- 568
- Registration Number
- NCT00557466
- Locations
- 🇬🇧
Novartis Investigator Site, Whitstable, United Kingdom
🇵🇱Novartis Investigator site, Mrozy, Poland
🇩🇪Novartis Investigator Site - 2 sites, Bonn, Germany
A Dose Ranging Trial of 4 Doses of Indacaterol Delivered Via TWISTHALER® Device in Adult and Adolescent Patients With Persistent Asthma
- Conditions
- Interventions
- First Posted Date
- 2007-10-17
- Last Posted Date
- 2013-01-18
- Lead Sponsor
- Novartis Pharmaceuticals
- Target Recruit Count
- 392
- Registration Number
- NCT00545272
- Locations
- 🇵🇱
Novartis Investigator site, Lubin, Poland
🇩🇪novartis Investigator site, Munchen, Germany
🇷🇺Novartis investigator site, Tomsk, Russian Federation
Safety of Exercise and High-dose Salbutamol in Patients With Chronic Obstructive Pulmonary Disease (COPD) Receiving Therapeutic Doses of Indacaterol (QAB 149) and Salmeterol
- Conditions
- Interventions
- First Posted Date
- 2007-09-18
- Last Posted Date
- 2012-05-23
- Lead Sponsor
- Novartis
- Target Recruit Count
- 27
- Registration Number
- NCT00531050
- Locations
- 🇧🇪
Novartis Investigative site, Antwerp, Belgium
26 Week Efficacy, Safety and Tolerability Study of Indacaterol in Patients With Chronic Obstructive Pulmonary Disease (COPD)
- First Posted Date
- 2007-04-20
- Last Posted Date
- 2011-08-18
- Lead Sponsor
- Novartis
- Target Recruit Count
- 2059
- Registration Number
- NCT00463567
- Locations
- 🇺🇸
Asthma & Allergy Research Associates, Dallas, Texas, United States
🇺🇸North Shore University Hospital, New Hyde Park, New York, United States
🇺🇸University of North Carolina, Chapel Hill, North Carolina, United States
Dose Ranging Study for Indacaterol in Japanese Asthma Patients
- First Posted Date
- 2006-11-27
- Last Posted Date
- 2011-08-17
- Lead Sponsor
- Novartis Pharmaceuticals
- Target Recruit Count
- 41
- Registration Number
- NCT00403754
- Locations
- 🇯🇵
Novartis, Tokyo, Japan
🇯🇵Novartis Investigator Site, Yokohama, Japan
🇯🇵Novartis Investigative Site, Tokyo, Japan
Efficacy, Safety, and Tolerability of Once Daily Indacaterol in Chronic Obstructive Pulmonary Disease (COPD) Using Formoterol Twice Daily as Active Control
- Conditions
- Interventions
- First Posted Date
- 2006-10-27
- Last Posted Date
- 2011-08-18
- Lead Sponsor
- Novartis
- Target Recruit Count
- 1732
- Registration Number
- NCT00393458
- Locations
- 🇬🇧
Novartis Investigator Site, Swansea, United Kingdom
🇪🇸Novartis Investigative Site, Madrid, Spain
🇹🇷Novartis, Istanbul, Turkey
Drug Development Updates
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