Indacaterol

Generic Name: Indacaterol

Brand Names: Hirobriz, Onbrez, Ultibro, Oslif Breezhaler, Hirobriz Breezhaler, Onbrez Breezhaler

Drug Type: Small Molecule

Chemical Formula: C_₂₄H_₂₈N_₂O_₃

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

Clinical Trials

Study to Evaluate Efficacy/Safety of Combination Budesonide/Indacaterol vs Fluticasone/Salmeterol in Patients With COPD

Phase 4

Completed

Conditions: Chronic Obstructive Pulmonary Disease

Interventions: Drug: Budesonide
Drug: Fluticasone
Drug: Indacaterol
Drug: Salmeterol

First Posted Date: 2014-02-05

Last Posted Date: 2017-04-18

Lead Sponsor: Novartis Pharmaceuticals

Target Recruit Count: 222

Registration Number: NCT02055352

Locations: 🇵🇦
Novartis Investigative Site, Panama City, Panamá, Panama

Ultra-long Acting Bronchodilator Therapy in Asthmatics

Phase 4

Completed

Conditions: Asthma

Interventions: Drug: Indacaterol and tiotropium
Drug: Indacaterol

First Posted Date: 2014-01-17

Last Posted Date: 2019-04-12

Lead Sponsor: University of Dundee

Target Recruit Count: 14

Registration Number: NCT02039011

Locations: 🇬🇧
Asthma and Allergy Research Group, University of Dundee, Dundee, United Kingdom

Indacaterol EfectIveness In COPD Patients With Tuberculosis History

Phase 3

Completed

Conditions: Patients With Moderate-to-severe COPD With Destroyed Lung by Tuberculosis

Interventions: Drug: Indacaterol
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

Phase 4

Completed

Conditions: Chronic Obstructive Pulmonary Disease (COPD)

Interventions: Drug: Indacaterol
Drug: Tiotropium

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

Comparison of Indacaterol With That of Placebo in 'Maintenance naïve' Patients With COPD Using Blinded Tiotropium as Active Control

Phase 4

Withdrawn

Conditions: Chronic Obstructive Pulmonary Disease (COPD)

Interventions: Drug: Placebo to tiotropium
Drug: Indacaterol
Drug: Placebo to indacaterol
Drug: Tiotropium

First Posted Date: 2012-10-26

Last Posted Date: 2017-04-20

Lead Sponsor: Novartis Pharmaceuticals

Registration Number: NCT01715311

Indacaterol Versus Tiotropium on Dynamic Hyperinflation in COPD

Phase 4

Completed

Conditions: Chronic Obstructive Pulmonary Disease

Interventions: Drug: Indacaterol
Drug: Tiotropium

First Posted Date: 2012-09-26

Last Posted Date: 2014-01-08

Lead Sponsor: Irmandade Santa Casa de Misericórdia de Porto Alegre

Target Recruit Count: 20

Registration Number: NCT01693003

Locations: 🇧🇷
Pavilhão Pereira Filho, Porto Alegre, RS, Brazil

Efficacy, Safety and Pharmacokinetics of Indacaterol Acetate in Patients With Persistent Asthma

Phase 2

Completed

Conditions: Asthma

Interventions: Drug: indacaterol
Drug: placebo
Drug: mometasone furoate

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

Comparison of Indacaterol 150 mcg Once Daily (o.d.) With Salmeterol/Fluticasone Propionate 50 mcg/500 mcg Twice Daily (b.i.d.)

Phase 4

Completed

Conditions: Chronic Obstructive Pulmonary Disease

Interventions: Drug: Indacaterol
Drug: Salmeterol

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

Phase 4

Completed

Conditions: COPD

Interventions: Drug: placebo
Drug: indacaterol

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

A Single-dose Study to Investigate the Effects of 3 Different Doses of Inhaled AZD2115 in COPD Patients

Phase 2

Completed

Conditions: COPD

Interventions: Drug: AZD2115
Drug: Placebo
Drug: Indacaterol
Drug: Indacaterol + Tiotropium

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

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