Chronic obstructive pulmonary disease (COPD) MedDRA version: 19.0 Level: LLT Classification code 10010952 Term: COPD System Organ Class: 100000004855
Conditions
Interventions
Trade Name: Seebri Breezhaler 44 micrograms inhalation powder, hard capsule
Product Name: Seebri Breezhaler 44 micrograms inhalation powder, hard capsule
Product Code: NVA237
Pharmaceutical Form: Inha
Sponsors
Novartis Pharma Services AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients who have signed an Informed Consent Form before any assessment is performed. 2. Male and female adults aged = 40 years. 3. Patients with moderate COPD according to the GOLD criteria 2013. 4. 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. An ex-smoker is defined as a subject who has not smoked for = 6 months at Visit 1.) 5. Patients with airflow limitation indicated by a post-bronchodilator FEV1 =50% and =80% of the predicted normal value and a post-bronchodilator FEV1/FVC =65 years) yes F.1.3.1 Number of subjects for this age range 3129
Exclusion criteria
Exclusion criteria: 1. Pts with condit. contraind.. for treatm. with, or having a history of reactions/ hypersensit. to any of the following inhal. drugs or to drugs of similar chem. classes or any comp. thereof: • Anti-cholinergic agents • Long- and short-acting ß2-adrenergic agonists • Sympathomimetic amines • Lactose or any of the other excipients of the trial medication. 2. Pts with narr.-angle glaucoma or urin. retent., severe ren. impairm. (hist. of estim. glom. filtr. rate below 30 ml/min/1.73 m2 within 12 mo prior to V1), incl. those with end-stage ren. dis. requir. dialysis. 3. Pts with active/ clin. hist. of asthma. If the Investig. finds clear and compelling evid. that a pt was misdiagnosed with asthma in the past, the burden of proof is on the Investig. to properly document this prev. misdiagnosis. This doc. must incl. the rationale for this change in diagn. incl. ref. to the differential diagn. that supports this decision. 4. Pts with a hist. of malign. of any organ syst. (other than local. basal cell carcin. of the skin), treat. or untreat., within the past 5 y, regardless of whether there is evid. of local recurr. or metastases. 5. Pts who have a post-bronchodilat. FEV1 decrease more than 10% compared to pre-bronchodilat. FEV1 result at Visit 2. 6. A doc. history of >1 COPD exacerb. requiring treatm. with syst. corticosteroids or atb and/or hospital. in the prev. 12 mo. Pts who haven´t had a COPD exacerb. in the prev. 12 mo and develop a COPD exacerb. between screening (V1) and baseline (V2) will not be eligible but will be permitted to be re-screen. after a min. of 6 wks after the resolut. of the COPD exacerb. (Pts suffer. an exacerb. between V1 and V2 can only be re-screen. in case it is the first one in the prev. 12 mo). In case this COPD exacerb. has let to an alteration of the pt COPD treatm., before this pt can be re-screen. 3 mo of stable COPD treatm. will be required as describ. in Incl. Crit. 6). 7. Pts who, in the judgm. of the investig., have a clin. relev. lab. abnorm. or a clin. signif. cond. such as (but not limited to): • Unstable ischem. heart dis., left ventric. failure (NYHA Class III & IV), hist. of myoc. infarct., arrhythmia (excl. chron. stable atrial fibrill.). Pts with such events not consid. clin. signif. by the investig. may be consid. for inclus. in the study • Uncontr. hypo-or hyperthyroidism, hypokalaemia or hyperadrenergic state • Any cond. which might comprom. pt safety or compl., interfere with eval., or preclude complet. of the study 8. History of resting QTcF (Fridericia pref., but Bazett accept.) >450 msec (male) or >460 msec (female) within 5y before V1. 9. Pts who are treat. with glyc. bromide (NVA237) at V1 aren´t allowed to be incl. into the trial. 10. Pts receiv. any other prohib. COPD-relat. med. specif. in Table 5-2. Prohib. COPD-rel. med. must undergo the requir. wash-out per. prior to V2. 11. Use of other inv. drugs within 5 half-lives of enroll. or within 30 days, whichever is longer. 12. Pregn. or nurs. women, where pregn. is def. as the state of a female after concept. and until the termin. of gest., conf. by a posit. hCG lab. test. 13. Women of child-bear. pot., def. as all women physiol. capable of bec. preg., unless they are using effect. methods of contrac. during dosing of study treatm. Effect. contrac. methods incl.: • Total abst. (when this is in line with the pref. and usual lifestyle of the subject. Periodic abst. (e.g., ca
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • To show the superiority of glycopyrronium (50 µg o.d.) vs. short-actingbronchodilators (SABA and/or SAMA as monotherapy or in free or FDC) on FEV1 at week 12. • To show the non-inferiority of glycopyrronium (50 µg o.d.) vs. long-acting bronchodilators (LABA or LAMA monotherapy) on on FEV1 at week12. • To show the superiority of indacaterol maleate and glycopyrronium bromide FDC (110/50 µg o.d.) vs. LABA and ICS in free or FDC on on FEV1 at week 12. • To show the superiority of indacaterol maleate and glycopyrronium bromide FDC (110/50 µg o.d.) vs. long-acting bronchodilators (LABA or LAMA monotherapy) on on FEV1 at week 12. • To show the superiority of glycopyrronium (50 µg o.d.) vs. short-actingbronchodilators (SABA and/or SAMA as monotherapy or in free or FDC) on Transition Dyspnea Index (TDI) at week 12. • To show the non-inferiority of glycopyrronium (50 µg o.d.) vs. long-acting bronchodilators (LABA or LAMA monotherapy) on on TDI at week 12.;Secondary Objective: • To show the non-inferiority of glycopyrronium (50 µg o.d) vs. short-actingbronchodilators (SABA and/or SAMA as monotherapy or in free or FDC) or long-actingbronchodilators (LABA or LAMA monotherapy) on trough FEV1 at week 12. • To show the non-inferiority of glycopyrronium (50 µg o.d) vs. short-acting bronchodilators (SABA and/or SAMA as monotherapy or in free or FDC) or long-acting bronchodilators (LABA or LAMA monotherapy) on TDI at week 12. • To show the superiority of indacaterol maleate and glycopyrronium bromide FDC (110/50µg o.d) vs. LABA or LAMA monotherapy or LABA and ICS in free or FDC on trough FEV1 total score at week 12. • To show the superiority of indacaterol maleate and glycopyrronium bromide FDC (110/50 µg o.d) vs. LABA or LAMA monotherapy or LABA and ICS in free or FDC on TDI total score at week 12. • To evaluate the effect of glycopyrronium (50 µg o.d.) and indacaterol maleate and glycopyrronium bromide FDC (110/50 µg o.d) vs. baseline therapy on.;Primary end point | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • To show the non-inferiority of glycopyrronium (50 µg o.d) vs. short-acting bronchodilators (SABA and/or SAMA as monotherapy or in free or FDC) or long-acting bronchodilators (LABA or LAMA monotherapy) on TDI at week 12. • To show the superiority of indacaterol maleate and glycopyrronium bromide FDC (110/50 µg o.d.) vs. LABA or LAMA monotherapy or LABA and ICS in free or FDC on TDI at week 12. • To evaluate the effect of glycopyrronium (50 µg o.d.) and indacaterol maleate and glycopyrronium bromide FDC (110/50 µg o.d.) vs. baseline therapy on: o Total score of COPD Assessment Test (CAT) at week 12 o Total score of Clinical COPD Questionnaire (CCQ) at week 12 o Mean number of puffs of rescue medication use and percentage of days without rescue medication use assessed by electronic patient diary (eDiary) over the 12-week treatment period o Patient-reported symptoms of COPD assessed by eDiary over the 12-week treatment period Safety and tolerability over the 12-week treatment period. ;Timepoint(s) of evaluation of this end point: week 12 | — |
Countries
Austria, Belgium, Czech Republic, Denmark, Estonia, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Norway, Poland, Portugal, Romania, Russian Federation, Slovakia, Slovenia, Spain, Sweden, United Kingdom
Contacts
Public ContactInformacní služba - klin. hodnocení
Novartis s.r.o.
Outcome results
None listed