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Clinical trials for Indacaterol

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44339   clinical trials with a EudraCT protocol, of which   7369   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
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    89 result(s) found for: Indacaterol. Displaying page 1 of 5.
    1  2  3  4  5  Next»
    EudraCT Number: 2016-002113-21 Sponsor Protocol Number: CQMF149G2202 Start Date*: 2016-12-21
    Sponsor Name:Novartis Pharma Services AG
    Full Title: A multicenter, randomized, double-blind, active-controlled, 2 week treatment, parallel-group study to assess the efficacy and safety of indacaterol acetate delivered via the Concept1 inhalation dev...
    Medical condition: lung function effects of two doses of indacaterol acetate, 75 μg and 150 μg, in pediatric asthma patients 6-11 years old
    Disease: Version SOC Term Classification Code Term Level
    20.0 10038738 - Respiratory, thoracic and mediastinal disorders 10003553 Asthma PT
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: DE (Completed) SK (Completed) BE (Completed) HU (Completed) HR (Completed)
    Trial results: View results
    EudraCT Number: 2011-001825-25 Sponsor Protocol Number: CIDD001A2201 Start Date*: 2011-11-01
    Sponsor Name:Novartis Pharma Services AG
    Full Title: A multi-centre, randomized, double-blind, double-dummy, multiple-dose, crossover study to evaluate the pharmacodynamics, pharmacokinetics, safety and tolerability of orally inhaled indacaterol admi...
    Medical condition: Asthma
    Disease: Version SOC Term Classification Code Term Level
    14.0 10038738 - Respiratory, thoracic and mediastinal disorders 10003553 Asthma PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: GB (Completed) DE (Completed)
    Trial results: View results
    EudraCT Number: 2013-003127-11 Sponsor Protocol Number: CQVA149A3401 Start Date*: 2014-02-26
    Sponsor Name:Novartis Pharma Services AG
    Full Title: A prospective, multicenter, 12-week, randomized open-label study to evaluate the efficacy and safety of glycopyrronium (50 micrograms o.d.) or indacaterol maleate and glycopyrronium bromide fixed-d...
    Medical condition: Chronic obstructive pulmonary disease (COPD)
    Disease: Version SOC Term Classification Code Term Level
    19.0 100000004855 10010952 COPD LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: CZ (Completed) LT (Completed) SK (Completed) BE (Completed) EE (Completed) LV (Completed) IE (Completed) SE (Completed) AT (Completed) PT (Completed) IT (Completed) GB (Completed) DK (Completed) GR (Completed) HU (Completed) PL (Completed) ES (Completed) DE (Completed) SI (Completed)
    Trial results: View results
    EudraCT Number: 2012-000520-18 Sponsor Protocol Number: CQMF149E2203 Start Date*: 2012-10-18
    Sponsor Name:Novartis Pharma Services AG
    Full Title: A multicenter, randomized, double-blind, placebo controlled, 12-week treatment, parallel-group study to assess the efficacy, safety and pharmacokinetics of indacaterol acetate (75 and 150 μg o.d.) ...
    Medical condition: Asthma
    Disease: Version SOC Term Classification Code Term Level
    15.1 10038738 - Respiratory, thoracic and mediastinal disorders 10003553 Asthma PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Completed) SK (Completed) DE (Completed) BG (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2005-004169-41 Sponsor Protocol Number: CQAB149B2329 Start Date*: 2006-01-19
    Sponsor Name:Novartis Pharma Services AG
    Full Title: A 52-week treatment, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to assess the efficacy, safety and tolerability of indacaterol (200 & 400 µg o.d) in patients wi...
    Medical condition: Chronic obstructive pulmonary disease (COPD)
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) SE (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2009-010589-46 Sponsor Protocol Number: CQAB149D2301 Start Date*: 2009-05-20
    Sponsor Name:Novartis Pharma Services AG
    Full Title: A multi-centre, randomized, double-blind, placebo controlled, multiple-dose, 4-way cross-over study to evaluate the efficacy, safety, tolerability and pharmacokinetics of orally inhaled indacaterol...
    Medical condition: persistent asthma
    Disease: Version SOC Term Classification Code Term Level
    9.1 10003553 Asthma LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) FR (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2009-013763-19 Sponsor Protocol Number: CQAB149BIT01 Start Date*: 2009-09-24
    Sponsor Name:NOVARTIS FARMA
    Full Title: Multicenter, randomized, blinded, placebo controlled, cross over, single dose study to assess the effect of indacaterol (150 �g) versus tiotropium (18 �g) on Inspiratory Capacity in moderate COPD p...
    Medical condition: moderate COPD
    Disease: Version SOC Term Classification Code Term Level
    12.0 10029978 Obstructive chronic bronchitis with acute exacerbation LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: View results
    EudraCT Number: 2015-002899-25 Sponsor Protocol Number: CQVM149B2302 Start Date*: 2015-12-17
    Sponsor Name:Novartis Pharma Services AG
    Full Title: A multicenter, randomized, 52-week, double-blind, parallel-group, active-controlled study to compare the efficacy and safety of QVM149 with QMF149 in patients with asthma
    Medical condition: Asthma
    Disease: Version SOC Term Classification Code Term Level
    20.0 10038738 - Respiratory, thoracic and mediastinal disorders 10003553 Asthma PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: EE (Completed) LT (Completed) DE (Completed) SK (Completed) PT (Completed) AT (Completed) HU (Completed) NL (Completed) FI (Completed) BE (Completed) ES (Completed) DK (Completed) LV (Completed) GR (Completed) FR (Completed) BG (Completed) IE (Completed) HR (Completed) SI (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2009-012600-48 Sponsor Protocol Number: CQAB149B2222 Start Date*: 2009-10-21
    Sponsor Name:Novartis Pharma Services AG
    Full Title: A randomized, partially-blinded, single-dose, 4-way crossover study to evaluate the efficacy, safety, tolerability and pharmacokinetics of orally inhaled indacaterol maleate administered via the Co...
    Medical condition: Asthma
    Disease: Version SOC Term Classification Code Term Level
    12.0 10003553 Asthma LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) GB (Completed) NL (Completed)
    Trial results: View results
    EudraCT Number: 2008-007944-33 Sponsor Protocol Number: CQAB149B2348 Start Date*: 2009-03-13
    Sponsor Name:Novartis Pharma Services AG
    Full Title: A phase IIIb multicenter, 52 week treatment, randomized, blinded, double dummy, parallel group efficacy study comparing the effect of inhaled indacaterol 150 μg o.d. vs inhaled tiotropium 18 μg o.d...
    Medical condition: Chronic Obstructive Pulmonary Disease (COPD)
    Disease: Version SOC Term Classification Code Term Level
    9.1 10010952 COPD LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Completed) ES (Completed) FI (Completed) SK (Completed) CZ (Completed) LT (Completed) IS (Completed) BE (Completed) PT (Completed) EE (Completed) DK (Completed) LV (Completed) HU (Completed) DE (Completed) FR (Completed) NL (Completed) PL (Completed) GB (Completed) SE (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2007-003191-19 Sponsor Protocol Number: CQMF149A2201 Start Date*: 2007-10-25
    Sponsor Name:Novartis Pharma Services AG
    Full Title: A randomized, multi-center, parallel group, double-blind, placebo and formetrol controlled 14 day dose ranging trial of 4 doses of indacaterol delivered via Twisthaler®, in adult and adolescent pa...
    Medical condition: persistent asthma
    Disease: Version SOC Term Classification Code Term Level
    9.1 10003553 Asthma LLT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed) CZ (Completed) ES (Completed) HU (Completed) GB (Completed) PL (Ongoing) SK (Completed) DE (Completed)
    Trial results: View results
    EudraCT Number: 2010-018481-22 Sponsor Protocol Number: CQAB149B2223 Start Date*: 2010-04-12
    Sponsor Name:Novartis Pharma Services AG
    Full Title: A multi-center, randomized, double-blind, placebo-controlled, parallel group, repeated-dose study to evaluate the efficacy, safety, tolerability and pharmacokinetics of three different dosing regim...
    Medical condition: Persistent asthma
    Disease: Version SOC Term Classification Code Term Level
    12.1 10003553 Asthma LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed) DE (Completed) GB (Completed) NL (Completed)
    Trial results: View results
    EudraCT Number: 2013-001953-28 Sponsor Protocol Number: 2012RC15 Start Date*: 2013-08-20
    Sponsor Name:Tayside Medical Sciences Centre on behalf of University of Dundee & NHS Tayside
    Full Title: Proof of concept study to evaluate single and chronic dosing effects of ultra-long acting bronchodilator therapy on mannitol challenge in asthmatic patients taking inhaled corticosteroids
    Medical condition: Asthma
    Disease: Version SOC Term Classification Code Term Level
    16.0 100000004855 10001705 Allergic asthma LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2008-000663-42 Sponsor Protocol Number: CQAB149B2335SE Start Date*: 2008-06-03
    Sponsor Name:Novartis Farmacéutica S.A
    Full Title: Extensión de 26 semanas del estudio multicéntrico, aleatorizado, doble ciego, controlado con placebo, con grupos paralelos y diseño adaptativo, de 26 semanas de tratamiento, para evaluar la segurid...
    Medical condition: Enfermedad Pulmonar Obstructiva Crónica (EPOC)
    Disease: Version SOC Term Classification Code Term Level
    9.1 10010952 COPD LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed) IT (Completed) DE (Completed) SE (Completed)
    Trial results: View results
    EudraCT Number: 2005-004168-21 Sponsor Protocol Number: CQAB149B2328 Start Date*: 2006-01-30
    Sponsor Name:Novartis Pharma Services AG
    Full Title: A 52-week treatment, multicenter, randomized, double-blind, double dummy, placebo-controlled, parallel-group study to assess the efficacy, safety and tolerability of indacaterol (200 & 400 µg o.d.)...
    Medical condition: Chronic obstructive pulmonary disease (COPD)
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) SE (Prematurely Ended) DE (Completed)
    Trial results: View results
    EudraCT Number: 2019-001762-14 Sponsor Protocol Number: 69765 Start Date*: 2020-07-29
    Sponsor Name:University Medical Center Groningen
    Full Title: Evaluation of the anti-inflammatory effects of glycopyrronium added to indacaterol/mometasone on the allergen-induced late asthmatic response
    Medical condition: Asthma
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2015-000473-12 Sponsor Protocol Number: ULT01 Start Date*: 2015-10-12
    Sponsor Name:UMCG
    Full Title: The effectiveness of single dose Ultibro Breezhaler (indacaterol/glycopyrronium) by sd-DPI versus ipratropium/salbutamol by nebulizer in improving FEV1 and dyspnea during stable state of COPD
    Medical condition: COPD, chronic obstructive pulmonary disease
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Completed)
    Trial results: View results
    EudraCT Number: 2006-003634-15 Sponsor Protocol Number: CQAB149B2211 Start Date*: 2006-09-13
    Sponsor Name:NovartisPharma Services AG
    Full Title: An exploratory, double-blind comparison of inspiratory capacity (IC) and FEV1 in COPD patients following single dose administration of indacaterol and placebo and open-label b.i.d. administration o...
    Medical condition: Mild to severe COPD
    Disease: Version SOC Term Classification Code Term Level
    8.1 10010952 COPD LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DK (Completed) DE (Completed) GB (Completed)
    Trial results: View results
    EudraCT Number: 2006-001954-28 Sponsor Protocol Number: CQAB149B2334 Start Date*: 2006-10-10
    Sponsor Name:NovartisPharma Services AG
    Full Title: A 52-week treatment, multicenter, randomized, double-blind, double dummy, placebo-controlled, parallel-group study to assess the efficacy, safety and tolerability of indacaterol (300 & 600 µg o.d.)...
    Medical condition: Chronic Obstructive Pulmonary Disease (COPD)
    Disease: Version SOC Term Classification Code Term Level
    8.1 10010952 COPD LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Completed) BE (Completed) DK (Completed) HU (Completed) GB (Completed) SK (Completed) DE (Completed) CZ (Completed) EE (Completed) LT (Completed) SE (Completed) LV (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2006-001955-37 Sponsor Protocol Number: CQAB149B2335S Start Date*: 2007-04-29
    Sponsor Name:Novartis Farmacéutica S.A
    Full Title: Estudio multicéntrico, aleatorizado, doble ciego, doble enmascarado, controlado con placebo, con grupos paralelos y diseño adaptativo, de 26 semanas de tratamiento, para evaluar la eficacia, seguri...
    Medical condition: Chronic Obstructive Pulmonary Disease (COPD)
    Disease: Version SOC Term Classification Code Term Level
    9.1 10010952 COPD LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed) DE (Completed) SE (Completed) IT (Completed)
    Trial results: View results
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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