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
Comparison of Indacaterol 150 mcg Once Daily (o.d.) With Salmeterol/Fluticasone Propionate 50 mcg/500 mcg Twice Daily (b.i.d.)
- Conditions
- Chronic Obstructive Pulmonary Disease
- Interventions
- First Posted Date
- 2012-03-15
- Last Posted Date
- 2015-04-28
- Lead Sponsor
- Novartis Pharmaceuticals
- Target Recruit Count
- 581
- Registration Number
- NCT01555138
- Locations
- 🇬🇧
Novartis Investigative Site, Surrey, United Kingdom
Indacaterol 75 μg Compared to Placebo, Assessing Time to Patient's Perception of Onset of Effect in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease
- First Posted Date
- 2012-03-05
- Last Posted Date
- 2013-05-10
- Lead Sponsor
- Novartis Pharmaceuticals
- Target Recruit Count
- 40
- Registration Number
- NCT01543828
- Locations
- 🇺🇸
Novartis Investigative Site, Tacoma, Washington, United States
Comparison of Safety and Efficacy of the Combination Product QVA149A Against the Concurrent Administration of the Individual Components, QAB149 and NVA237, in Patients With Chronic Obstructive Pulmonary Disease (COPD)
- Conditions
- Chronic Obstructive Pulmonary Disease
- Interventions
- First Posted Date
- 2012-02-09
- Last Posted Date
- 2014-02-12
- Lead Sponsor
- Novartis Pharmaceuticals
- Target Recruit Count
- 193
- Registration Number
- NCT01529632
- Locations
- 🇸🇪
Novartis Investigative Site, Uddevalla, Sweden
A Single-dose Study to Investigate the Effects of 3 Different Doses of Inhaled AZD2115 in COPD Patients
- Conditions
- COPD
- Interventions
- First Posted Date
- 2011-12-23
- Last Posted Date
- 2012-10-26
- Lead Sponsor
- AstraZeneca
- Target Recruit Count
- 39
- Registration Number
- NCT01498081
- Locations
- 🇸🇪
Research Site, Lund, Sweden
Closing Volume Interpretation and Bronchodilators Effect
- First Posted Date
- 2011-09-21
- Last Posted Date
- 2014-10-29
- Lead Sponsor
- University of Milan
- Target Recruit Count
- 40
- Registration Number
- NCT01437748
- Locations
- 🇮🇹
Pneumologia Riabilitativa-Fondazione Maugeri-Istituto Scientifico di Milano- IRCCS, Milano, Italy
Efficacy of Indacaterol 150 µg Versus Formoterol
- Conditions
- Chronic Obstructive Pulmonary Disease (COPD)
- Interventions
- First Posted Date
- 2011-06-21
- Last Posted Date
- 2017-04-20
- Lead Sponsor
- Novartis Pharmaceuticals
- Registration Number
- NCT01377428
Effect of Indacaterol Maleate in Chronic Obstructive Pulmonary Disease (COPD) on Lung Volume and Related Dyspnea
- Conditions
- COPDDyspneaHypoxemiaLung DiseasesTachycardia
- Interventions
- Drug: Placebo
- First Posted Date
- 2011-06-20
- Last Posted Date
- 2014-10-29
- Lead Sponsor
- University of Milan
- Target Recruit Count
- 60
- Registration Number
- NCT01377051
- Locations
- 🇮🇹
Pneumologia Riabilitativa - Fondazione Maugeri - Istituto Scientifico di Milano - IRCCS, Milano, Italy
QVA149 Versus Fluticasone/Salmeterol in Patients With Chronic Obstructive Pulmonary Disease (COPD)
- Conditions
- Chronic Obstructive Pulmonary Disease (COPD)
- Interventions
- Drug: fluticasone/salmeterolDrug: Placebo to fluticasone/salmeterol
- First Posted Date
- 2011-03-15
- Last Posted Date
- 2013-08-09
- Lead Sponsor
- Novartis Pharmaceuticals
- Target Recruit Count
- 523
- Registration Number
- NCT01315249
- Locations
- 🇪🇸
Novartis Investigative Site, Valladolid, Spain
Effect of QVA149 on Exercise Tolerance in Patients With Chronic Obstructive Pulmonary Disease (COPD)
- Conditions
- COPD
- Interventions
- First Posted Date
- 2011-02-11
- Last Posted Date
- 2013-03-20
- Lead Sponsor
- Novartis Pharmaceuticals
- Target Recruit Count
- 85
- Registration Number
- NCT01294787
- Locations
- 🇪🇸
Novartis Investigative Site, Malaga, Spain
To Determine the Relationship Between Baseline Reversibility and the Efficacy of Indacaterol
- Conditions
- Chronic Obstructive Pulmonary Disease (COPD)
- Interventions
- 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
Drug Development Updates
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