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
Indacaterol EfectIveness In COPD Patients With Tuberculosis History
- Conditions
- Patients With Moderate-to-severe COPD With Destroyed Lung by Tuberculosis
- Interventions
- Drug: Control
- First Posted Date
- 2013-01-29
- Last Posted Date
- 2015-10-23
- Lead Sponsor
- Novartis Pharmaceuticals
- Target Recruit Count
- 136
- Registration Number
- NCT01778062
- Locations
- 🇰🇷
Novartis Investigative Site, Seoul, Korea, Republic of
Study Evaluating Preference, Satisfaction And Correct Use Of Inhalers In COPD Patients
- Conditions
- Chronic Obstructive Pulmonary Disease (COPD)
- Interventions
- First Posted Date
- 2012-11-15
- Last Posted Date
- 2017-01-24
- Lead Sponsor
- Novartis Pharmaceuticals
- Target Recruit Count
- 140
- Registration Number
- NCT01727024
- Locations
- 🇧🇷
Novartis Investigative Site, São Paulo, SP, Brazil
A 12 Week Treatment, Multi-center, Randomized, Double-blind, Parallel-group, Placebo and Active Controlled Study to Assess the Efficacy, Safety, and Tolerability of Indacaterol Maleate / Glycopyrronium Bromide in COPD Patients With Moderate to Severe Airflow Limitation.
- Conditions
- Chronic Obstructive Pulmonary Disease (COPD)
- Interventions
- First Posted Date
- 2012-11-15
- Last Posted Date
- 2016-03-29
- Lead Sponsor
- Novartis Pharmaceuticals
- Target Recruit Count
- 1042
- Registration Number
- NCT01727141
- Locations
- 🇻🇳
Novartis Investigative Site, Ho Chi Minh, Vietnam
Comparison of Indacaterol With That of Placebo in 'Maintenance naïve' Patients With COPD Using Blinded Tiotropium as Active Control
- Conditions
- Chronic Obstructive Pulmonary Disease (COPD)
- Interventions
- First Posted Date
- 2012-10-26
- Last Posted Date
- 2017-04-20
- Lead Sponsor
- Novartis Pharmaceuticals
- Registration Number
- NCT01715311
A 12-week Treatment, Multi-center, Randomized, Double-blind, Parallel-group, Placebo and Active Controlled Study to Assess the Efficacy, Safety, and Tolerability of Indacaterol Maleate / Glycopyrronium Bromide in COPD Patients With Moderate to Severe Airflow Limitation
- Conditions
- Chronic Obstructive Pulmonary Disease (COPD)
- Interventions
- First Posted Date
- 2012-10-23
- Last Posted Date
- 2015-07-15
- Lead Sponsor
- Novartis Pharmaceuticals
- Target Recruit Count
- 1001
- Registration Number
- NCT01712516
- Locations
- 🇸🇮
Novartis Investigative Site, Golnik, Slovenia
Swiss studY for the Treatment of COPD Patients With the Free combiNation of indacatERol and GlYcopyrroniumbromide.
- Conditions
- Chronic Obstructive Pulmonary Disease: COPD
- Interventions
- First Posted Date
- 2012-10-04
- Last Posted Date
- 2016-02-09
- Lead Sponsor
- Novartis Pharmaceuticals
- Target Recruit Count
- 79
- Registration Number
- NCT01699685
- Locations
- 🇨🇭
Novartis Investigative Site, Walenstadtberg, Switzerland
Indacaterol Versus Tiotropium on Dynamic Hyperinflation in COPD
- Conditions
- Chronic Obstructive Pulmonary Disease
- Interventions
- First Posted Date
- 2012-09-26
- Last Posted Date
- 2014-01-08
- Target Recruit Count
- 20
- Registration Number
- NCT01693003
- Locations
- 🇧🇷
Pavilhão Pereira Filho, Porto Alegre, RS, Brazil
A Multi-centre Randomized Double Blind 52-week Study to Assess the Safety of QVA149 Compared to QAB149 in Patients With COPD Who Have Moderate to Severe Airflow Limitation
- Conditions
- Chronic Obstructive Pulmonary Disease (COPD)
- Interventions
- First Posted Date
- 2012-09-11
- Last Posted Date
- 2016-03-30
- Lead Sponsor
- Novartis Pharmaceuticals
- Target Recruit Count
- 614
- Registration Number
- NCT01682863
- Locations
- 🇪🇸
Novartis Investigative Site, Valencia, Comunidad Valenciana, Spain
Efficacy and Safety of QMF149 vs. Salmeterol Xinafoate/Fluticasone Propionate in Patients With Chronic Obstructive Pulmonary Disease (COPD)
- First Posted Date
- 2012-07-10
- Last Posted Date
- 2014-11-17
- Lead Sponsor
- Novartis Pharmaceuticals
- Target Recruit Count
- 629
- Registration Number
- NCT01636076
- Locations
- 🇹🇭
Novartis Investigative Site, Songkla, Thailand
Efficacy, Safety and Pharmacokinetics of Indacaterol Acetate in Patients With Persistent Asthma
- First Posted Date
- 2012-06-01
- Last Posted Date
- 2015-01-27
- Lead Sponsor
- Novartis Pharmaceuticals
- Target Recruit Count
- 335
- Registration Number
- NCT01609478
- Locations
- 🇸🇰
Novartis Investigative Site, Zvolen, Slovakia
Drug Development Updates
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