Study to Evaluate the Efficacy and Safety of Glycopyrronium or Indacaterol Maleate and Glycopyrronium Bromide Fixed-dose Combination Regarding Symptoms and Health Status in Patients With Moderate COPD Switching From Treatment With Any Standard COPD Regimen

COPD Clinical Trial

Official 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-dose Combination (110/50 Micrograms o.d.) Regarding Symptoms and Health Status in Patients With Moderate Chronic Obstructive Pulmonary Disease (COPD) Switching From Treatment With Any Standard COPD Regimen

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01985334
• Other study ID #: CQVA149A3401
• Status: Completed
• Phase: Phase 4
• Start date: February 14, 2014
• Est. completion date: April 29, 2016

Study information

• Verified date: March 2019
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The main goal of this study is to evaluate the efficacy and safety of glycopyrronium bromide and indacaterol maleate and glycopyrronium bromide fixed dose combination (FDC) in patients with moderate COPD who switch from their current COPD therapy. This study aims to provide data on how non-exacerbating, but still symptomatic patients with moderate COPD switching from their current COPD treatment to glycopyrronium bromide or indacaterol maleate and glycopyrronium bromide FDC maintain or improve their symptoms. Another purpose of this study is to increase awareness and usage of validated COPD symptoms tools and dyspnea questionnaires in order to facilitate clinical assessment and improve early diagnosis of symptomatic patients.

Description:

The treatment epoch will last 12 weeks. The total duration of the study for each patient is 12 weeks (from randomization) plus 30 days of safety follow-up.

The study has three phases: screening phase (=wash-out period, if required), treatment phase and safety follow-up phase.

Eligible patients will be randomized to either receive glycopyrronium or indacaterol maleate and glycopyrronium bromide fixed dose combination or to remain in their baseline therapy, in an allocation ratio of 3:1 for each cluster (Groups A, B, C, and D), based on their COPD symptoms and baseline treatment:

Group A: Patients treated with any SABA ( Short-acting β2-adrenergic agonist) and/or SAMA (Short-acting muscarinic antagonist) as monotherapy or in free or fixed dose combination (FDC) will be assigned to glycopyrronium or will remain in their baseline therapy (3:1) Group B: Patients treated with any LABA (Long-acting β2-adrenergic agonist) or LAMA (Long-acting muscarinic antagonist) monotherapy and mMRC score =1 point will be assigned to glycopyrronium or will remain in their baseline therapy (3:1) Group C: Patients treated with any LABA and ICS (Inhaled corticosteroid) in free or FDC will be assigned to indacaterol maleate and glycopyrronium bromide fixed dose combination or will remain in their baseline therapy (3:1) Group D: Patients treated with any LABA or LAMA monotherapy and mMRC score >1 point will be assigned to indacaterol maleate and glycopyrronium bromide fixed dose combination or will remain in their baseline therapy (3:1) Due to low recruitment in Groups A and B that would lead to a significant delay of trial completion, a protocol amendment was made in order to close the recruitment of Groups A and B at the time the randomization in Groups C and D would be completed. Recruitment of the Groups C and D continued as originally planned

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4389
• Est. completion date: April 29, 2016
• Est. primary completion date: April 29, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 95 Years

Eligibility

Inclusion Criteria:

• Male and female adults aged = 40 years

• Patients with moderate COPD according to the GOLD criteria 2013

• Current or ex-smokers who have a smoking history of at least 10 pack years

• Patients with airflow limitation indicated by a postbronchodilator FEV1 =50% and <80% of the predicted normal value and a post-bronchodilator FEV1/FVC <0.7 at Visit 2. Post- bronchodilator refers to within 10-15 min of inhalation of 400 µg (4x100 µg) of salbutamol

• Patients who, at Visit 1, have been for at least 3 months on a stable dose of one of the following COPD baseline treatments: *Any SABA monotherapy (such as, but not limited to, salbutamol) *Any SAMA monotherapy (such as, but not limited to, ipratropium) *Any SABA and SAMA in free or FDC (such as, but not limited to, salbutamol/ipratropium) *Any LABA monotherapy (such as, but not limited to, formoterol, salmeterol, indacaterol) *Any LAMA monotherapy (such as, but not limited to, tiotropium, aclidinium) except glycopyrronium bromide (NVA237) *Any LABA and ICS in free (ICS such as, but not limited to, beclomethasone, fluticasone) or FDC (such as, but not limited to, salmeterol/fluticasone, formoterol/budesonide).

• Patients with an mMRC score =1 at Visit 1.

Exclusion Criteria:

• Patients with conditions contraindicated for treatment with, or having a history of reactions/ hypersensitivity to any of the following inhaled drugs or to drugs of similar chemical classes or any component thereof: Anti-cholinergic agents, Long- and short-acting 2-adrenergic agonists, Sympathomimetic amines, Lactose or any of the other excipients of the trial medication.

• Patients with narrow-angle glaucoma or urinary retention, severe renal impairment (history of estimated glomerular filtration rate below 30 ml/min/1.73 m2 within 12 months prior to visit 1), including those with end-stage renal disease requiring dialysis.

• Patients with active/ clinical history of asthma.If the Investigator finds clear and compelling evidence that a patient was misdiagnosed with asthma in the past, then the burden of proof is on the Investigator to properly document this previous misdiagnosis. This documentation must include the rationale for this change in diagnosis including reference to the differential diagnosis that supports this decision.

• Patients with a history of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases.

• Patients who have a post-bronchodilator FEV1 decrease more than 10% compared to pre-bronchodilator FEV1 result at Visit 2 (see Appendix 5 for details).

• A documented history of >1 COPD exacerbation requiring treatment with systemic corticosteroids or antibiotics and/or hospitalization in the previous 12 months.

• Patients who have NOT had a COPD exacerbation in the previous 12 months and develop a COPD exacerbation between screening (Visit 1) and (Visit 2) will not be eligible but will be permitted to be re-screened after a minimum of 6 weeks after the resolution of the COPD exacerbation. (Patients suffering an exacerbation between Visit 1 and Visit 2 can only be re-screened in case it is the first one in the previous 12 months. In case this COPD exacerbation has led to an alteration of the patient COPD treatment, before this patient can be re-screened 3 months of stable COPD treatment will be required as described in Inclusion Criterion 6).

• Patients who, in the judgment of the investigator, have a clinically relevant laboratory abnormality or a clinically significant condition such as (but not limited to): *Unstable ischemic heart disease, left ventricular failure (NYHA Class III & IV), history of myocardial infarction,arrhythmia (excluding chronic stable atrial fibrillation). Patients with such events not considered clinically significant by the investigator may be considered for inclusion in the study.*Uncontrolled hypo-or hyperthyroidism, hypokalaemia or hyperadrenergic state. *Any condition which might compromise patient safety or compliance, interfere with evaluation, or preclude completion of the study

• History of resting QTc (Fridericia preferred, but Bazett acceptable) >450 msec (male) or >460 msec (female) within five years before Visit 1.

• Patients who are treated with glycopyrronium bromide (NVA237) at visit 1 are not allowed to be included into the trialPatients on non-selective beta-blockers. Those patients may enter the study after non-selective beta-blocker withdrawal during a 7-day wash-out period.

• Patients receiving any other prohibited COPD-related medications specified in Table 5-2 Prohibited COPD related medications must undergo the required wash-out period prior to Visit 2.

• Patients who are, in the opinion of the investigator known to be unreliable or non-compliant.

• Patients with a body mass index (BMI) of more than 40 kg/m2.

• Use of other investigational drugs within 5 half-lives of enrollment or within 30 days, whichever is longer.

• Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test.

• Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using effective methods of contraception during dosing of study treatment.

Related Conditions & MeSH terms

• COPD
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• Glycopyrronium
Glycopyrronium 50 µg capsule for inhalation via SDDPI once per day
• SABA
Short-acting ß2-adrenergic agonist (SABA) as per approved by each country and as prescribed for each patient, used as background therapy
• LABA
Long Acting Beta Agonist (LABA) as per approved by each country and as prescribed for each patient, used as background therapy
• Indacaterol maleate and glycopyrronium bromide
Indacaterol maleate and glycopyrronium bromide fixed dose combination (110/50 µg) capsule for inhalation via SDDPI, once a day
• LAMA
Long Acting Muscarinic Antagonist (LAMA) as per approved by each country and as prescribed for each patient, used as background therapy
• SAMA
Short-acting muscarinic antagonist (SAMA) as per approved by each country and as prescribed for each patient, used as background therapy
• ICS
Inhaled corticosteroid (ICS) as per approved by each country and as prescribed for each patient, used as background therapy

Locations

Country	Name	City	State
Austria	Novartis Investigative Site	Amstetten
Austria	Novartis Investigative Site	Feldkirch
Austria	Novartis Investigative Site	Hallein
Austria	Novartis Investigative Site	Kirchdorf an der Krems
Austria	Novartis Investigative Site	Leoben
Austria	Novartis Investigative Site	Linz
Austria	Novartis Investigative Site	Perg
Austria	Novartis Investigative Site	Salzburg
Austria	Novartis Investigative Site	Wels
Belgium	Novartis Investigative Site	Antwerpen
Belgium	Novartis Investigative Site	Balen
Belgium	Novartis Investigative Site	Braine l'Alleud
Belgium	Novartis Investigative Site	Brussels
Belgium	Novartis Investigative Site	Bruxelles
Belgium	Novartis Investigative Site	Bruxelles
Belgium	Novartis Investigative Site	Eghezee
Belgium	Novartis Investigative Site	Erpent
Belgium	Novartis Investigative Site	Geraardsbergen
Belgium	Novartis Investigative Site	Gilly
Belgium	Novartis Investigative Site	Gosselies	BEL
Belgium	Novartis Investigative Site	Gozee	BEL
Belgium	Novartis Investigative Site	Halen
Belgium	Novartis Investigative Site	Hasselt
Belgium	Novartis Investigative Site	Heusy
Belgium	Novartis Investigative Site	Ieper
Belgium	Novartis Investigative Site	Knokke-Heist
Belgium	Novartis Investigative Site	Lebbeke
Belgium	Novartis Investigative Site	Liege
Belgium	Novartis Investigative Site	Maaseik
Belgium	Novartis Investigative Site	Malmedy
Belgium	Novartis Investigative Site	Mechelen
Belgium	Novartis Investigative Site	Melsbroek
Belgium	Novartis Investigative Site	Merksem
Belgium	Novartis Investigative Site	Montegnée
Belgium	Novartis Investigative Site	Natoye
Belgium	Novartis Investigative Site	Paal-Beringen
Belgium	Novartis Investigative Site	Ronse
Belgium	Novartis Investigative Site	Saint-Medard
Belgium	Novartis Investigative Site	Seraing
Belgium	Novartis Investigative Site	Tournai
Belgium	Novartis Investigative Site	Verviers
Belgium	Novartis Investigative Site	Vilvoorde
Belgium	Novartis Investigative Site	Zichem	BEL
Belgium	Novartis Investigative Site	Zottegem
Czechia	Novartis Investigative Site	Boskovice	Czech Republic
Czechia	Novartis Investigative Site	Brandys Nad Labem	Czech Republic
Czechia	Novartis Investigative Site	Brno-Kralovo Pole	Czech Republic
Czechia	Novartis Investigative Site	Cvikov	Czech Republic
Czechia	Novartis Investigative Site	Havlickuv Brod	Czech Republic
Czechia	Novartis Investigative Site	Jirkov	Czech Republic
Czechia	Novartis Investigative Site	Kurim	Czech Republic
Czechia	Novartis Investigative Site	Liberec	Czech Republic
Czechia	Novartis Investigative Site	Lovosice	Czech Republic
Czechia	Novartis Investigative Site	Neratovice	Czech Republic
Czechia	Novartis Investigative Site	Ostrava	Czech Republic
Czechia	Novartis Investigative Site	Pardubice	Czech Republic
Czechia	Novartis Investigative Site	Plzen	Czech Republic
Czechia	Novartis Investigative Site	Plzen	Czech Republic
Czechia	Novartis Investigative Site	Prague	Czech Republic
Czechia	Novartis Investigative Site	Prague 4	Czech Republic
Czechia	Novartis Investigative Site	Praha	Czech Republic
Czechia	Novartis Investigative Site	Praha 10	Czech Republic
Czechia	Novartis Investigative Site	Praha 4	Czech Republic
Czechia	Novartis Investigative Site	Praha 6	Czech Republic
Czechia	Novartis Investigative Site	Praha 8
Czechia	Novartis Investigative Site	Praha 9	Czech Republic
Czechia	Novartis Investigative Site	Rokycany	Czech Republic
Czechia	Novartis Investigative Site	Rudna	Czech Republic
Czechia	Novartis Investigative Site	Teplice	Czech Republic
Czechia	Novartis Investigative Site	Trebic	Czech Republic
Czechia	Novartis Investigative Site	Varnsdorf	Czech Republic
Czechia	Novartis Investigative Site	Zatec	Czech Republic
Czechia	Novartis Investigative Site	Znojmo	Czech Republic
Denmark	Novartis Investigative Site	Alleroed
Denmark	Novartis Investigative Site	Greve
Denmark	Novartis Investigative Site	Haslev
Denmark	Novartis Investigative Site	Søborg
Denmark	Novartis Investigative Site	Værløse
Estonia	Novartis Investigative Site	Paide
Estonia	Novartis Investigative Site	Tallinn
Estonia	Novartis Investigative Site	Tallinn
Estonia	Novartis Investigative Site	Tallinn
Estonia	Novartis Investigative Site	Tallinn
Estonia	Novartis Investigative Site	Tartu
France	Novartis Investigative Site	Briis Sous Forges
France	Novartis Investigative Site	Chamalieres
France	Novartis Investigative Site	Chatellerault
France	Novartis Investigative Site	Forbach
France	Novartis Investigative Site	L'Aigle
France	Novartis Investigative Site	La Bouexiere
France	Novartis Investigative Site	Marseille
France	Novartis Investigative Site	Montpellier
France	Novartis Investigative Site	Murs Erigne
France	Novartis Investigative Site	Nice
France	Novartis Investigative Site	Saint Jean de Luz
France	Novartis Investigative Site	Saint Laurent Du Var
France	Novartis Investigative Site	Saint Pierre
France	Novartis Investigative Site	Strasbourg
France	Novartis Investigative Site	Toulon
France	Novartis Investigative Site	Tours Cedex 9	Indre Et Loire
Germany	Novartis Investigative Site	Annaberg-Buchholz
Germany	Novartis Investigative Site	Auerbach
Germany	Novartis Investigative Site	Augsburg
Germany	Novartis Investigative Site	Bad Neustadt
Germany	Novartis Investigative Site	Bad Salzuflen
Germany	Novartis Investigative Site	Bad Woerishofen
Germany	Novartis Investigative Site	Bamberg
Germany	Novartis Investigative Site	Bensheim
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Bielefeld
Germany	Novartis Investigative Site	Bochum
Germany	Novartis Investigative Site	Bonn
Germany	Novartis Investigative Site	Bonn
Germany	Novartis Investigative Site	Bottrop
Germany	Novartis Investigative Site	Bruchsal
Germany	Novartis Investigative Site	Burgwedel
Germany	Novartis Investigative Site	Cottbus	Sachsen
Germany	Novartis Investigative Site	Daaden
Germany	Novartis Investigative Site	Dachau
Germany	Novartis Investigative Site	Deggendorf
Germany	Novartis Investigative Site	Deggingen
Germany	Novartis Investigative Site	Delitzsch
Germany	Novartis Investigative Site	Dortmund
Germany	Novartis Investigative Site	Dresden
Germany	Novartis Investigative Site	Dresden
Germany	Novartis Investigative Site	Dueren
Germany	Novartis Investigative Site	Dusseldorf
Germany	Novartis Investigative Site	Düsseldorf
Germany	Novartis Investigative Site	Eisenach
Germany	Novartis Investigative Site	Elsterwerda
Germany	Novartis Investigative Site	Erlangen
Germany	Novartis Investigative Site	Essen
Germany	Novartis Investigative Site	Essen
Germany	Novartis Investigative Site	Essen
Germany	Novartis Investigative Site	Essen
Germany	Novartis Investigative Site	Essen
Germany	Novartis Investigative Site	Essen
Germany	Novartis Investigative Site	Essen	Rheinland Pfalz
Germany	Novartis Investigative Site	Foehren
Germany	Novartis Investigative Site	Frankenberg (Eder)
Germany	Novartis Investigative Site	Frankfurt
Germany	Novartis Investigative Site	Frankfurt am Main
Germany	Novartis Investigative Site	Freiburg
Germany	Novartis Investigative Site	Freudenberg
Germany	Novartis Investigative Site	Furstenwalde
Germany	Novartis Investigative Site	Fürstenwalde/Spree
Germany	Novartis Investigative Site	Garmisch-Partenkirchen
Germany	Novartis Investigative Site	Gauting
Germany	Novartis Investigative Site	Geesthacht	Schleswig Holstein
Germany	Novartis Investigative Site	Gießen
Germany	Novartis Investigative Site	Gifhorn
Germany	Novartis Investigative Site	Goch
Germany	Novartis Investigative Site	Goerlitz
Germany	Novartis Investigative Site	Gummersbach
Germany	Novartis Investigative Site	Gütersloh
Germany	Novartis Investigative Site	Hagen
Germany	Novartis Investigative Site	Halberstadt
Germany	Novartis Investigative Site	Halle
Germany	Novartis Investigative Site	Hamburg
Germany	Novartis Investigative Site	Hamburg
Germany	Novartis Investigative Site	Hamburg
Germany	Novartis Investigative Site	Hamburg
Germany	Novartis Investigative Site	Hamburg
Germany	Novartis Investigative Site	Hamburg
Germany	Novartis Investigative Site	Hamburg
Germany	Novartis Investigative Site	Hannover
Germany	Novartis Investigative Site	Hannover
Germany	Novartis Investigative Site	Hannover
Germany	Novartis Investigative Site	Hannover	Niedersachsen
Germany	Novartis Investigative Site	Heidelberg
Germany	Novartis Investigative Site	Hettstedt
Germany	Novartis Investigative Site	Hildesheim
Germany	Novartis Investigative Site	Hoyerswerda
Germany	Novartis Investigative Site	Jena
Germany	Novartis Investigative Site	Jerichow
Germany	Novartis Investigative Site	Kamen
Germany	Novartis Investigative Site	Karlsruhe
Germany	Novartis Investigative Site	Kassel
Germany	Novartis Investigative Site	Kassel
Germany	Novartis Investigative Site	Kiel
Germany	Novartis Investigative Site	Kleve
Germany	Novartis Investigative Site	Koblenz	NRW
Germany	Novartis Investigative Site	Koeln
Germany	Novartis Investigative Site	Koeln
Germany	Novartis Investigative Site	Koeln
Germany	Novartis Investigative Site	Koeln
Germany	Novartis Investigative Site	Köthen
Germany	Novartis Investigative Site	Landau-Pfalz
Germany	Novartis Investigative Site	Landsberg
Germany	Novartis Investigative Site	Leipzig
Germany	Novartis Investigative Site	Leipzig
Germany	Novartis Investigative Site	Leipzig
Germany	Novartis Investigative Site	Leipzig
Germany	Novartis Investigative Site	Leipzig
Germany	Novartis Investigative Site	Leonberg
Germany	Novartis Investigative Site	Leverkusen
Germany	Novartis Investigative Site	Limburgerhof
Germany	Novartis Investigative Site	Loehne
Germany	Novartis Investigative Site	Lübeck
Germany	Novartis Investigative Site	Ludwigsburg
Germany	Novartis Investigative Site	Ludwigshafen
Germany	Novartis Investigative Site	Ludwigshafen
Germany	Novartis Investigative Site	Luedenscheid
Germany	Novartis Investigative Site	Magdeburg
Germany	Novartis Investigative Site	Marburg
Germany	Novartis Investigative Site	Marburg
Germany	Novartis Investigative Site	Marburg
Germany	Novartis Investigative Site	Mayen
Germany	Novartis Investigative Site	Meine
Germany	Novartis Investigative Site	Meissen
Germany	Novartis Investigative Site	Menden
Germany	Novartis Investigative Site	Minden
Germany	Novartis Investigative Site	Mittweida
Germany	Novartis Investigative Site	Mülheim
Germany	Novartis Investigative Site	München
Germany	Novartis Investigative Site	München
Germany	Novartis Investigative Site	Münnerstadt
Germany	Novartis Investigative Site	Neu Isenburg
Germany	Novartis Investigative Site	Neu-Ulm
Germany	Novartis Investigative Site	Neunkirchen
Germany	Novartis Investigative Site	Neuss
Germany	Novartis Investigative Site	Neuwied
Germany	Novartis Investigative Site	Northeim
Germany	Novartis Investigative Site	Nürnberg
Germany	Novartis Investigative Site	Nürnberg
Germany	Novartis Investigative Site	Obermichelbach
Germany	Novartis Investigative Site	Oschatz
Germany	Novartis Investigative Site	Oschersleben
Germany	Novartis Investigative Site	Osnabrueck
Germany	Novartis Investigative Site	Papenburg
Germany	Novartis Investigative Site	Passau
Germany	Novartis Investigative Site	Peine	Niedersachsen
Germany	Novartis Investigative Site	Plauen
Germany	Novartis Investigative Site	Potsdam
Germany	Novartis Investigative Site	Potsdam
Germany	Novartis Investigative Site	Prien A. Chiemsee
Germany	Novartis Investigative Site	Radebeul
Germany	Novartis Investigative Site	Ratingen
Germany	Novartis Investigative Site	Raubach
Germany	Novartis Investigative Site	Reinfeld
Germany	Novartis Investigative Site	Rheine
Germany	Novartis Investigative Site	Rodenbach
Germany	Novartis Investigative Site	Roth
Germany	Novartis Investigative Site	Rudersdorf
Germany	Novartis Investigative Site	Rüsselsheim
Germany	Novartis Investigative Site	Rüsselsheim,
Germany	Novartis Investigative Site	Saalfeld
Germany	Novartis Investigative Site	Saarbruecken
Germany	Novartis Investigative Site	Schleswig
Germany	Novartis Investigative Site	Schwabach
Germany	Novartis Investigative Site	Schwedt
Germany	Novartis Investigative Site	Schwerin
Germany	Novartis Investigative Site	Schwetzingen
Germany	Novartis Investigative Site	Siegen
Germany	Novartis Investigative Site	Sinsheim
Germany	Novartis Investigative Site	Solingen
Germany	Novartis Investigative Site	Solingen
Germany	Novartis Investigative Site	Solingen
Germany	Novartis Investigative Site	Sonneberg
Germany	Novartis Investigative Site	Strausberg
Germany	Novartis Investigative Site	Teuchern
Germany	Novartis Investigative Site	Ulm
Germany	Novartis Investigative Site	Wardenburg
Germany	Novartis Investigative Site	Warendorf	Nordrhein-Westfalen
Germany	Novartis Investigative Site	Weilheim
Germany	Novartis Investigative Site	Welzheim
Germany	Novartis Investigative Site	Westerkappeln
Germany	Novartis Investigative Site	Wiesloch
Germany	Novartis Investigative Site	Wissen
Germany	Novartis Investigative Site	Witten
Germany	Novartis Investigative Site	Woellstein
Germany	Novartis Investigative Site	Wolfsburg
Germany	Novartis Investigative Site	Zerbst
Greece	Novartis Investigative Site	Athens	GR
Greece	Novartis Investigative Site	Serres
Greece	Novartis Investigative Site	Thessaloniki	GR
Hungary	Novartis Investigative Site	Cegled
Hungary	Novartis Investigative Site	Debrecen
Hungary	Novartis Investigative Site	Gyor	HUN
Hungary	Novartis Investigative Site	Hatvan
Hungary	Novartis Investigative Site	Komarom
Hungary	Novartis Investigative Site	Mako
Hungary	Novartis Investigative Site	Mateszalka
Hungary	Novartis Investigative Site	Pecs
Hungary	Novartis Investigative Site	Pecs
Hungary	Novartis Investigative Site	Szazhalombatta	HUN
Hungary	Novartis Investigative Site	Szeged
Hungary	Novartis Investigative Site	Tatabanya
Hungary	Novartis Investigative Site	Torokbalint
Ireland	Novartis Investigative Site	County Limerick
Ireland	Novartis Investigative Site	Dublin
Ireland	Novartis Investigative Site	Dublin
Ireland	Novartis Investigative Site	Dublin 7
Italy	Novartis Investigative Site	Ancona	AN
Italy	Novartis Investigative Site	Arzignano	VI
Italy	Novartis Investigative Site	Avellino	AV
Italy	Novartis Investigative Site	Bari	BA
Italy	Novartis Investigative Site	Bari	BA
Italy	Novartis Investigative Site	Brescia	BS
Italy	Novartis Investigative Site	Bussolengo	VR
Italy	Novartis Investigative Site	Busto Arsizio	VA
Italy	Novartis Investigative Site	Caltanissetta	CL
Italy	Novartis Investigative Site	Campobasso	CB
Italy	Novartis Investigative Site	Catania	CT
Italy	Novartis Investigative Site	Catania	CT
Italy	Novartis Investigative Site	Catania	CT
Italy	Novartis Investigative Site	Cittadella	PD
Italy	Novartis Investigative Site	Feltre	BL
Italy	Novartis Investigative Site	Firenze	FI
Italy	Novartis Investigative Site	Firenze	FI
Italy	Novartis Investigative Site	Foggia	FG
Italy	Novartis Investigative Site	Forlì	FC
Italy	Novartis Investigative Site	Genova	GE
Italy	Novartis Investigative Site	Lido di Camaiore	LU
Italy	Novartis Investigative Site	Livorno	LI
Italy	Novartis Investigative Site	Lodi	LO
Italy	Novartis Investigative Site	Marcianise	CE
Italy	Novartis Investigative Site	Montebelluna	TV
Italy	Novartis Investigative Site	Monza	MB
Italy	Novartis Investigative Site	Napoli
Italy	Novartis Investigative Site	Nuoro	NU
Italy	Novartis Investigative Site	Orbassano	TO
Italy	Novartis Investigative Site	Palermo	PA
Italy	Novartis Investigative Site	Palermo	PA
Italy	Novartis Investigative Site	Piacenza	PC
Italy	Novartis Investigative Site	Pisa	PI
Italy	Novartis Investigative Site	Pordenone	PN
Italy	Novartis Investigative Site	Riccione	RN
Italy	Novartis Investigative Site	Roma	RM
Italy	Novartis Investigative Site	Roma	RM
Italy	Novartis Investigative Site	Roma	RM
Italy	Novartis Investigative Site	Roma	RM
Italy	Novartis Investigative Site	Romano di Lombardia	BG
Italy	Novartis Investigative Site	Rozzano	MI
Italy	Novartis Investigative Site	Saluzzo	CN
Italy	Novartis Investigative Site	San Pietro Vernotico	BR
Italy	Novartis Investigative Site	San Severo	FG
Italy	Novartis Investigative Site	Sassari	SS
Italy	Novartis Investigative Site	Siena	SI
Italy	Novartis Investigative Site	Sondalo	SO
Italy	Novartis Investigative Site	Telese Terme	BN
Italy	Novartis Investigative Site	Terlizzi	BA
Italy	Novartis Investigative Site	Terni	TR
Italy	Novartis Investigative Site	Torino
Italy	Novartis Investigative Site	Triggiano	BA
Italy	Novartis Investigative Site	Vicenza	VI
Italy	Novartis Investigative Site	Vittorio Veneto	TV
Italy	Novartis Investigative Site	Voghera	PV
Latvia	Novartis Investigative Site	Balvi	LVA
Latvia	Novartis Investigative Site	Daugavpils
Latvia	Novartis Investigative Site	Jurmala	LVA
Latvia	Novartis Investigative Site	Riga	LV
Latvia	Novartis Investigative Site	Riga	LV
Latvia	Novartis Investigative Site	Riga
Latvia	Novartis Investigative Site	Riga
Lithuania	Novartis Investigative Site	Alytus
Lithuania	Novartis Investigative Site	Kaunas
Lithuania	Novartis Investigative Site	Kaunas	LT
Lithuania	Novartis Investigative Site	Klaipeda
Lithuania	Novartis Investigative Site	Utena
Lithuania	Novartis Investigative Site	Vilnius
Lithuania	Novartis Investigative Site	Vilnius
Lithuania	Novartis Investigative Site	Vilnius	LT
Lithuania	Novartis Investigative Site	Vilnius	LTU
Norway	Novartis Investigative Site	Førde
Norway	Novartis Investigative Site	Kløfta
Norway	Novartis Investigative Site	Lierskogen
Norway	Novartis Investigative Site	Oslo
Norway	Novartis Investigative Site	Oslo
Norway	Novartis Investigative Site	Skedsmokorset
Norway	Novartis Investigative Site	Skien
Norway	Novartis Investigative Site	Stavanger
Norway	Novartis Investigative Site	Tananger
Poland	Novartis Investigative Site	Bialystok
Poland	Novartis Investigative Site	Krakow
Poland	Novartis Investigative Site	Nowy Dwor Mazowiecki
Poland	Novartis Investigative Site	Ostrow Wielkopolski
Poland	Novartis Investigative Site	Pila
Poland	Novartis Investigative Site	Sopot
Poland	Novartis Investigative Site	Warszawa
Poland	Novartis Investigative Site	Wroclaw
Portugal	Novartis Investigative Site	Aveiro
Portugal	Novartis Investigative Site	Barcelos
Portugal	Novartis Investigative Site	Coimbra
Portugal	Novartis Investigative Site	Guimarães
Portugal	Novartis Investigative Site	Lisboa
Portugal	Novartis Investigative Site	Lisboa
Portugal	Novartis Investigative Site	Porto
Portugal	Novartis Investigative Site	Vila Franca de Xira
Portugal	Novartis Investigative Site	Vila Nova de Gaia
Romania	Novartis Investigative Site	Bacau
Romania	Novartis Investigative Site	Bragadiru
Romania	Novartis Investigative Site	Bucharest	District 3
Romania	Novartis Investigative Site	Constanta
Romania	Novartis Investigative Site	Iasi	Jud. Iasi
Romania	Novartis Investigative Site	Ramnicu Valcea
Romania	Novartis Investigative Site	Suceava
Romania	Novartis Investigative Site	Timisoara
Russian Federation	Novartis Investigative Site	Chelyabinsk
Russian Federation	Novartis Investigative Site	Kazan
Russian Federation	Novartis Investigative Site	Kemerovo
Russian Federation	Novartis Investigative Site	Moscow
Russian Federation	Novartis Investigative Site	Moscow
Russian Federation	Novartis Investigative Site	N.Novgorod
Russian Federation	Novartis Investigative Site	Novosibirsk
Russian Federation	Novartis Investigative Site	Ryazan
Russian Federation	Novartis Investigative Site	Saint Petersburg
Russian Federation	Novartis Investigative Site	Saratov
Russian Federation	Novartis Investigative Site	Smolensk
Russian Federation	Novartis Investigative Site	St. Petersburg
Russian Federation	Novartis Investigative Site	Tomsk
Russian Federation	Novartis Investigative Site	Ufa
Russian Federation	Novartis Investigative Site	Yaroslavl
Slovakia	Novartis Investigative Site	Bardejov	Slovak Republic
Slovakia	Novartis Investigative Site	Bojnice	Slovak Republic
Slovakia	Novartis Investigative Site	Kralovsky Chlmec
Slovakia	Novartis Investigative Site	Levice
Slovakia	Novartis Investigative Site	Liptovsky Hradok	Slovak Republic
Slovakia	Novartis Investigative Site	Námestovo	Slovensko
Slovakia	Novartis Investigative Site	Poprad
Slovakia	Novartis Investigative Site	Presov
Slovakia	Novartis Investigative Site	Presov
Slovakia	Novartis Investigative Site	Sala
Slovakia	Novartis Investigative Site	Sturovo
Slovakia	Novartis Investigative Site	Trnava
Slovakia	Novartis Investigative Site	Vrable
Slovenia	Novartis Investigative Site	Golnik
Slovenia	Novartis Investigative Site	Kranj
Slovenia	Novartis Investigative Site	Maribor
Slovenia	Novartis Investigative Site	Murska Sobota
Spain	Novartis Investigative Site	Alzira	Comunidad Valenciana
Spain	Novartis Investigative Site	Badalona	Barcelona
Spain	Novartis Investigative Site	Badalona	Catalunya
Spain	Novartis Investigative Site	Barcelona	Cataluña
Spain	Novartis Investigative Site	Barcelona	Cataluna
Spain	Novartis Investigative Site	Benidorm	Comunidad Valenciana
Spain	Novartis Investigative Site	Caceres	Extremadura
Spain	Novartis Investigative Site	Canet de Mar	Cataluna
Spain	Novartis Investigative Site	Centelles	Barcelona
Spain	Novartis Investigative Site	Cordoba	Andalucia
Spain	Novartis Investigative Site	Madrid
Spain	Novartis Investigative Site	Madrid
Spain	Novartis Investigative Site	Madrid
Spain	Novartis Investigative Site	Madrid	Madrid, Communidad De
Spain	Novartis Investigative Site	Málaga	Andalucia
Spain	Novartis Investigative Site	Mallorca	Islas Baleares
Spain	Novartis Investigative Site	Marbella	Andalucia
Spain	Novartis Investigative Site	Marbella	Andalucia
Spain	Novartis Investigative Site	Mataro	Barcelona
Spain	Novartis Investigative Site	Merida	Extremadura
Spain	Novartis Investigative Site	Mostoles	Madrid, Communidad De
Spain	Novartis Investigative Site	Motril	Granada
Spain	Novartis Investigative Site	Palma de Mallorca	Islas Baleares
Spain	Novartis Investigative Site	Ponferrada	Castilla Y Leon
Spain	Novartis Investigative Site	Puerto De Sagunto	Comunidad Valenciana
Spain	Novartis Investigative Site	Sabadell	Barcelona
Spain	Novartis Investigative Site	Salamanca	Castilla Y Leon
Spain	Novartis Investigative Site	Sant Boi de Llobregat	Cataluna
Spain	Novartis Investigative Site	Sant Joan Despi	Barcelona
Spain	Novartis Investigative Site	Santiago de Compostela
Spain	Novartis Investigative Site	Valdemoro	Madrid
Spain	Novartis Investigative Site	Valencia	Comunidad Valenciana
Spain	Novartis Investigative Site	Valencia	Comunidad Valenciana
Spain	Novartis Investigative Site	Valencia	Comunidad Valenciana
Spain	Novartis Investigative Site	Valencia	Comunidad Valenciana
Spain	Novartis Investigative Site	Valencia	Comunidad Valenciana
Spain	Novartis Investigative Site	Vic	Barcelona
Spain	Novartis Investigative Site	Vic	Cataluña
Spain	Novartis Investigative Site	Zaragoza
Sweden	Novartis Investigative Site	Goteborg
Sweden	Novartis Investigative Site	Gustavsberg
Sweden	Novartis Investigative Site	Helsingborg
Sweden	Novartis Investigative Site	Hollviken
Sweden	Novartis Investigative Site	Kungshamn
Sweden	Novartis Investigative Site	Limhamn
Sweden	Novartis Investigative Site	Linkoping	Ostergotlands Lan
Sweden	Novartis Investigative Site	Lund
Sweden	Novartis Investigative Site	Råå
Sweden	Novartis Investigative Site	Umea
Sweden	Novartis Investigative Site	Vastra Frolunda
United Kingdom	Novartis Investigative Site	Axbridge	Somerset
United Kingdom	Novartis Investigative Site	Aylesbury	Bucks
United Kingdom	Novartis Investigative Site	Barry	Vale Of Glamorgan
United Kingdom	Novartis Investigative Site	Bath	England
United Kingdom	Novartis Investigative Site	Bexhill-on-Sea
United Kingdom	Novartis Investigative Site	Bradford	West Yorkshire
United Kingdom	Novartis Investigative Site	Bristol
United Kingdom	Novartis Investigative Site	Bristol
United Kingdom	Novartis Investigative Site	Burbage	Leicester
United Kingdom	Novartis Investigative Site	Cardiff
United Kingdom	Novartis Investigative Site	Chadderton
United Kingdom	Novartis Investigative Site	Cheshire
United Kingdom	Novartis Investigative Site	Chesterfield
United Kingdom	Novartis Investigative Site	Chippenham
United Kingdom	Novartis Investigative Site	Coventry
United Kingdom	Novartis Investigative Site	Crawley	West Sussex
United Kingdom	Novartis Investigative Site	Daventry	Northamptonshire
United Kingdom	Novartis Investigative Site	Fowey	Cornwall
United Kingdom	Novartis Investigative Site	Frome	Somerset
United Kingdom	Novartis Investigative Site	Hamilton
United Kingdom	Novartis Investigative Site	Havant	Hampshire
United Kingdom	Novartis Investigative Site	Lancashire
United Kingdom	Novartis Investigative Site	Leamington Spa	Warwickshire
United Kingdom	Novartis Investigative Site	Liskeard	Cornwall
United Kingdom	Novartis Investigative Site	Manchester
United Kingdom	Novartis Investigative Site	Motherwell
United Kingdom	Novartis Investigative Site	Oldham
United Kingdom	Novartis Investigative Site	Penzance	Cornwall
United Kingdom	Novartis Investigative Site	Plymouth
United Kingdom	Novartis Investigative Site	Redruth	Cornwall
United Kingdom	Novartis Investigative Site	Shrewsbury
United Kingdom	Novartis Investigative Site	Sneinton	Nottingham
United Kingdom	Novartis Investigative Site	South Shields	Tyne And Wear
United Kingdom	Novartis Investigative Site	South Yorkshire
United Kingdom	Novartis Investigative Site	St Austell	Cornwall
United Kingdom	Novartis Investigative Site	Stockton on Tees
United Kingdom	Novartis Investigative Site	Strensall	Yorkshire
United Kingdom	Novartis Investigative Site	Taunton	Somerset
United Kingdom	Novartis Investigative Site	Torpoint	Cornwall
United Kingdom	Novartis Investigative Site	Trowbridge	Wiltshire
United Kingdom	Novartis Investigative Site	Vale Of Glanmorgan
United Kingdom	Novartis Investigative Site	Watford
United Kingdom	Novartis Investigative Site	Wiltshire
United Kingdom	Novartis Investigative Site	Wishaw

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

Austria,  Belgium,  Czechia,  Denmark,  Estonia,  France,  Germany,  Greece,  Hungary,  Ireland,  Italy,  Latvia,  Lithuania,  Norway,  Poland,  Portugal,  Romania,  Russian Federation,  Slovakia,  Slovenia,  Spain,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Trough FEV1 at Week 12 for Group: Glycopyrronium vs. Short-acting Bronchodilators (SABA and/or SAMA as Monotherapy or in Free or FDC)	Trough FEV1 at visit 4 is defined as FEV1, computed as the mean of forced expiratory volume in 1 second 15min and 45 min pre dose measurements, at the end of the dosing interval	Week 12 (Visit 4)
Primary	Trough FEV1 at Week 12 for Group: Glycopyrronium vs. Long-acting Bronchodilators (LABA or LAMA Monotherapy)	Trough FEV1 at visit 4 is defined as FEV1, computed as the mean of forced expiratory volume in 1 second 15min and 45 min pre dose measurements, at the end of the dosing interval	Week 12 (Visit 4)
Primary	Trough FEV1 at Week 12 for Group: Indacaterol Maleate and Glycopyrronium Bromide FDC vs. LABA and ICS in Free or FDC	Trough FEV1 at visit 4 is defined as FEV1, computed as the mean of forced expiratory volume in 1 second 15min and 45 min pre dose measurements, at the end of the dosing interval.	Week 12 (Visit 4)
Primary	Trough FEV1 at Week 12 for Group: Indacaterol Maleate and Glycopyrronium Bromide FDC vs. Long-acting Bronchodilators (LABA or LAMA Monotherapy)	Trough FEV1 at visit 4 is defined as FEV1, computed as the mean of forced expiratory volume in 1 second 15min and 45 min pre dose measurements, at the end of the dosing interval.	Week 12 (Visit 4)
Primary	Change From Baseline on Transition Dyspnea Index (TDI) for Groups: Glycopyrronium vs. Short-acting Bronchodilators (SABA and/or SAMA as Monotherapy or in Free or FDC)	Transition Dyspnea Index (TDI) captures changes from baseline. The TDI score is based on three domains with each domain scored from -3 (major deterioration) to +3 (major improvement), to give an overall score of -9 to +9, a negative score indicating a deterioration from baseline. A TDI focal score of 1 is considered to be a clinically significant improvement from baseline.	Day 1 (baseline) and week 12
Primary	Change From Baseline on Transition Dyspnea Index (TDI) for Groups: Glycopyrronium vs. Long-acting Bronchodilators (LABA or LAMA Monotherapy)	Transition Dyspnea Index (TDI) captures changes from baseline. The TDI score is based on three domains with each domain scored from -3 (major deterioration) to +3 (major improvement), to give an overall score of -9 to +9, a negative score indicating a deterioration from baseline. A TDI focal score of 1 is considered to be a clinically significant improvement from baseline.	Day 1 (baseline) and week 12
Primary	Change From Baseline on Transition Dyspnea Index (TDI) for Groups: Indacaterol Maleate and Glycopyrronium Bromide FDC vs. LABA and ICS in Free or FDC	Transition Dyspnea Index (TDI) captures changes from baseline. The TDI score is based on three domains with each domain scored from -3 (major deterioration) to +3 (major improvement), to give an overall score of -9 to +9, a negative score indicating a deterioration from baseline. A TDI focal score of 1 is considered to be a clinically significant improvement from baseline.	Day 1 (baseline) and week 12
Primary	Change From Baseline on Transition Dyspnea Index (TDI) for Groups: Indacaterol Maleate and Glycopyrronium Bromide FDC vs. Long-acting Bronchodilators (LABA or LAMA Monotherapy)	Transition Dyspnea Index (TDI) captures changes from baseline. The TDI score is based on three domains with each domain scored from -3 (major deterioration) to +3 (major improvement), to give an overall score of -9 to +9, a negative score indicating a deterioration from baseline. A TDI focal score of 1 is considered to be a clinically significant improvement from baseline.	Day 1 (baseline) and week 12
Secondary	Trough FEV1 at Week 12 for Group: Glycopyrronium vs. Short-acting Bronchodilators (SABA and/or SAMA as Monotherapy or in Free or FDC) or vs. Long-acting Bronchodilators (LABA or LAMA Monotherapy)	Trough FEV1 at visit 4 is defined as FEV1, computed as the mean of forced expiratory volume in 1 second 15min and 45 min pre dose measurements, at the end of the dosing interval	12 Weeks
Secondary	Change From Baseline on on Transition Dyspnea Index (TDI) for Groups: Glycopyrronium vs. Short-acting Bronchodilators (SABA and/or SAMA as Monotherapy or in Free or FDC) or Long-acting Bronchodilators (LABA or LAMA Monotherapy)	Transition Dyspnea Index (TDI) captures changes from baseline. The TDI score is based on three domains with each domain scored from -3 (major deterioration) to +3 (major improvement), to give an overall score of -9 to +9, a negative score indicating a deterioration from baseline. A TDI focal score of 1 is considered to be a clinically significant improvement from baseline.	Day 1 (baseline) and week 12
Secondary	Trough FEV1 at Week 12 for Group: Indacaterol Maleate and Glycopyrronium Bromide FDC vs. LABA or LAMA Monotherapy or LABA and ICS in Free or FDC on Trough FEV1 at Week 12.	Trough FEV1 at visit 4 is defined as FEV1, computed as the mean of forced expiratory volume in 1 second 15min and 45 min pre dose measurements, at the end of the dosing interval.	12 Weeks
Secondary	Change From Baseline on Transition Dyspnea Index (TDI) for Groups: Indacaterol Maleate and Glycopyrronium Bromide FDC vs. LABA or LAMA Monotherapy or LABA and ICS in Free or FDC	Transition Dyspnea Index (TDI) captures changes from baseline. The TDI score is based on three domains with each domain scored from -3 (major deterioration) to +3 (major improvement), to give an overall score of -9 to +9, a negative score indicating a deterioration from baseline. A TDI focal score of 1 is considered to be a clinically significant improvement from baseline.	Day 1 (baseline) and week 12
Secondary	Change From Baseline on Total Score of COPD Assessment Test (CAT) for Groups: Glycopyrronium and Indacaterol Maleate and Glycopyrronium Bromide FDC	Total score of COPD Assessment Test (CAT) will be measured at baseline and at week 12. This questionnaire is completed by the patient. The score ranges from 0-40 where higher scores represent worse health status. CAT scores = 10 are associated with significantly impaired health status.	Day 1 (baseline) and Week 12
Secondary	Change From Baseline on Total Score of Clinical COPD Questionnaire (CCQ) for Groups: Glycopyrronium and Indacaterol Maleate and Glycopyrronium Bromide FDC	The Clinical COPD Questionnaire (CCQ) is a self-administered 10-item questionnaire developed to measure clinical control in patients with COPD. Patients will be instructed to recall their experiences during the previous week. They respond to each question using a 7-point scale from 0 = asymptomatic/no imitation to 6 = extremely symptomatic/totally limited. The questionnaire is divided into 3 domains (symptoms [items 1, 2, 5, and 6] functional [items 7, 8, 9, and 10] and mental state [items 3 and 4]). The overall clinical COPD control score and the scores of the domains are calculated by adding all the scores together and dividing this sum by the number of questions.; Thus, the overall clinical COPD control score as well as the score on each of the three domains varies between 0 (very good control) to 6 (extremely poor control).	Day 1 (baseline) and Week 12
Secondary	Mean Number of Puffs of Rescue Medication Use for Groups: Glycopyrronium and Indacaterol Maleate and Glycopyrronium Bromide FDC	Mean number of puffs of rescue medication use will be measured using eDiary data over 12 weeks of treatment.	12 weeks
Secondary	Mean Change From Baseline Reported Symptoms of COPD for Groups: Glycopyrronium and Indacaterol Maleate and Glycopyrronium Bromide FDC	Patient-reported symptoms of COPD combined will be measured using eDiary data reported over the 12 week treatment period. The mean total symptom scores and mean individual symptom scores for the patient were calculated for the whole study period. The mean change from baseline in the total scores and in the individual scores were summarized by treatment and were analyzed for the percentage of nights with no nighttime awakenings and percentage of days with no symptoms.	Baseline, 12 weeks