E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Chronic obstructive pulmonary disease |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10009032 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To confirm that NVA237 50μg o.d. (delivered via a SDDPI) vs placebo significantly increases mean 24 h post-dose (trough) FEV1 following 12 weeks of treatment in patients with moderate to severe COPD (GOLD Guidelines 2008) |
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E.2.2 | Secondary objectives of the trial |
evaluate the effect of NVA237 (50μg o.d.) vs placebo on breathlessness measured using the Transition Dyspnea Index (TDI) after 26 weeks treatment. evaluate the effect of NVA237 (50μg o.d.) vs placebo on the total score of the St Georges Respiratory Questionnaire (SGRQ) after 52 weeks treatment. |
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E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
FARMACOGENETICA: Versione:2 Data:2009/04/17 Titolo:Valutazioni esploratorie di farmacogenetica Obiettivi:Valutazioni esploratorie di farmacogenetica sono pianificate come parte di questo studio con gli obiettivi di valutare se la variazione genetica individuale dei geni correlati con il metabolismo dei farmaci, con la BPCO e con i meccanismi target del farmaco conferisce risposte differenti al NVA237
FARMACOCINETICA/FARMACODINAMICA: Versione:2 Data:2009/04/17 Titolo:Valutazioni di farmacocinetica Obiettivi:Valutare la farmacocinetica di NVA237 e l`effetto di diverse covariate sulle variabili della farmacocinetica di NVA237
ALTRI SOTTOSTUDI: Holter 24 ore e spirometria 24 ore
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E.3 | Principal inclusion criteria |
1. Male or female adults aged &#8805;40 years, who have signed an Informed Consent Form prior to initiation of any study-related procedure. 2. Patients with moderate to severe stable COPD (Stage II or Stage III) according to the (GOLD Guidelines 2008). 3. Current or ex-smokers who have a smoking history of at least 10 pack years. (Ten pack-years are defined as 20 cigarettes a day for 10 years, or 10 cigarettes a day for 20 years etc.) 4. Patients with a post-bronchodilator FEV1 &#8805;30% and < 80% of the predicted normal, and post-bronchodilator FEV1/FVC < 0.7 at Visit 2 (day -14) 5. Patients, according to daily electronic diary data between Visit 2 (-14) and Visit 3 (day 1), with a total score of 1 or more on at least 4 of the last 7 days prior to Visit 3 (For scoring information see Section 7.4.3.1.) |
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E.4 | Principal exclusion criteria |
1. Pregnant women or nursing mothers 2. Women of child-bearing potential, as defined in the protocol 3. Patients requiring long term oxygen therapy (> 15 h a day) on a daily basis for chronic hypoxemia, or who have been hospitalized for an exacerbation of their airways disease in the 6 weeks prior to Visit 1 or between Visit 1 (day -21) and Visit 3 (day 1). 4. Patients who have had a lower respiratory tract infection within 6 weeks prior to Visit 1 (day -21). Patients who develop a lower respiratory tract infection or COPD exacerbation during the screening period (up to Visit 3 (day 1)) will not be eligible, but will be permitted to be re-screened at a later date (at least 6 weeks after the resolution of the lower respiratory tract infection). 5. Patients who, in the judgment of the investigator or the responsible Novartis personnel, have a clinically relevant laboratory abnormality or a clinically significant condition such as (but not limited to): unstable ischemic heart disease, left ventricular failure, history of myocardial infarction, arrhythmia (excluding chronic stable AF) history of malignancy of any organ system (including lung cancer), treated or untreated, within the past 5 years whether or not there is evidence of local recurrence or metastases, with the exception of localized basal cell carcinoma of the skin. narrow-angle glaucoma symptomatic prostatic hyperplasia or bladder-neck obstruction or moderate to severe renal impairment or urinary retention any condition which might compromise patient safety or compliance, interfere with evaluation, or preclude completion of the study 6. Patients with any history of asthma indicated by (but not limited to) a blood eosinophil count > 600/mm3 (at visit 1) or onset of symptoms prior to age 40 years. 7. Patients with a history of long QT syndrome or whose QTc measured at Visit 1 (day -21) (Fridericia method) is prolonged (>450 ms for males or >470 for females). 8. Treatments for COPD and allied conditions: the following medications should not be used between Visits 1 (day -21) and 3 (day 1). The minimum washout prior to Visit 2 (Day -14) is specified below. For patients in the Holter monitor sub-group minimum washout is prior to the day before Visit 2 (day -15): The long acting anticholinergic agent tiotropium:7 days. Short acting anticholinergics: 8 h Fixed combinations of &#946;2-agonists and inhaled corticosteroids: 48 hours. (Patients taking fixed combinations of &#946;2-agonists and inhaled corticosteroids must be switched to the equivalent inhaled corticosteroid as monotherapy plus salbutamol/albuterol as rescue therapy at least 48 hours prior to Visit 2) Long-acting &#946;2-agonists: 48 h Short acting &#946;2-agonists (other than those prescribed in the study): 6 h Theophylline (any formulation): 7 days Combinations of inhaled short acting anticholinergics and short acting &#946;2-agonists: 12 hours 9. Patients who need the following treatments for COPD and allied conditions unless they have been stabilized as follows: Inhaled corticosteroids, in recommended and constant doses and dose regimens (previously given as part of a fixed dose combination of LABA + ICS) at least one month prior to Visit 1. Intranasal corticosteroids, in recommended and constant doses and dose regimens - at least one month prior to Visit 1. H1 antagonists at least 5 days prior to Visit 1. 10. Long term oral prednisone therapy (or equivalent), defined as &#8805; 10mg daily for at least 1 month prior to Visit1(day-21). |
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E.5 End points |
E.5.1 | Primary end point(s) |
Mean trough FEV1 after 12 weeks treatment imputed with LOCF |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Yes |
E.6.11 | Pharmacogenomic | Yes |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 3 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 65 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 4 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 8 |