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
Verified date | March 2019 |
Source | Novartis |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
Country | Name | City | State |
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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 |
Lead Sponsor | Collaborator |
---|---|
Novartis Pharmaceuticals |
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,
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 |
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