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 Neohaler. Indacaterol is provided as its maleate salt form. Indacaterol is also a chiral molecule but only the pure R-enantiomer is dispensed.
- 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 and Safety of QVA149 in Patients With Chronic Obstructive Pulmonary Disease (COPD)
- Conditions
- Chronic Obstructive Pulmonary Disease (COPD)
- 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
Efficacy and Safety of Indacaterol in Patients With Chronic Obstructive Pulmonary Disease (COPD) Using Salmeterol as Active Control
- Conditions
- Chronic Obstructive Pulmonary Disease (COPD)
- Interventions
- First Posted Date
- 2007-12-05
- Last Posted Date
- 2011-08-18
- Lead Sponsor
- Novartis
- Target Recruit Count
- 1002
- Registration Number
- NCT00567996
- Locations
- 🇫🇷
Novartis Investgative Site, Ferolles-Attilly, France
🇮🇹Novartis investigator site, Chieti, Italy
🇮🇹Novartis Investigative Site, Ascoli Piceno, Italy
A Dose Ranging Trial of 4 Doses of Indacaterol Delivered Via the TWISTHALER® Device in Patients With Chronic Obstructive Pulmonary Disease (COPD)
- Conditions
- COPD
- Interventions
- Drug: short acting β2- agonist
- 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
Investigation of the 24 Hour Forced Expiratory Flow in 1 Second (FEV1) Profile of a Single Dose of Indacaterol/Mometasone Delivered Via the TWISTHALER® Device in Adult Patients With Persistent Asthma
- Conditions
- Asthma
- Interventions
- Drug: placebo to indacaterol/mometasone
- First Posted Date
- 2007-11-14
- Last Posted Date
- 2013-03-21
- Lead Sponsor
- Novartis
- Target Recruit Count
- 37
- Registration Number
- NCT00557440
- Locations
- 🇩🇪
Novartis Investigator Site, Rostock, Germany
🇧🇪Novartis Investigator site, Ghent, Belgium
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
- Chronic Obstructive Pulmonary Disease (COPD)
- 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
Bronchodilatory Efficacy of a Single Dose QMF149 (Indacaterol Maleate/Mometasone Furoate) Via the Twisthaler® Device in Adult Patients With Asthma
- Conditions
- Asthma
- Interventions
- Drug: placebo to indacaterol maleate/mometasone furoate
- First Posted Date
- 2007-11-12
- Last Posted Date
- 2013-04-22
- Lead Sponsor
- Novartis
- Target Recruit Count
- 31
- Registration Number
- NCT00556673
- Locations
- 🇩🇪
Novartis Investigator Site, Berlin, Germany
A Dose Ranging Trial of 4 Doses of Indacaterol Delivered Via TWISTHALER® Device in Adult and Adolescent Patients With Persistent Asthma
- Conditions
- Asthma
- Interventions
- Drug: short acting β2-agonist
- 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
- Chronic Obstructive Pulmonary Disease
- 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
Safety of Indacaterol in Patients (≥ 12 Years) With Moderate to Severe Persistent Asthma
- Conditions
- Asthma
- Interventions
- First Posted Date
- 2007-09-14
- Last Posted Date
- 2011-08-29
- Lead Sponsor
- Novartis Pharmaceuticals
- Target Recruit Count
- 805
- Registration Number
- NCT00529529
- Locations
- 🇹🇷
Novartis Investigator Site, Izmir, Turkey
🇺🇸Novartis Investigator Site x 2 sites, Pensacola, Florida, United States
🇺🇸Novartis Investigator site, Houston, Texas, United States
26 Week Efficacy, Safety and Tolerability Study of Indacaterol in Patients With Chronic Obstructive Pulmonary Disease (COPD)
- Conditions
- Pulmonary Disease, Chronic ObstructiveCOPDLung Diseases, Obstructive
- Interventions
- 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
Drug Development Updates
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