Chronic Obstructive Pulmonary Disease (COPD) MedDRA version: 18.0 Level: LLT Classification code 10010952 Term: COPD System Organ Class: 100000004855
Conditions
Interventions
Trade Name: Ultibro Breezhaler
Product Name: indacaterol maleate/glycopyrronium bromide
Product Code: QVA149
Pharmaceutical Form: Inhalation powder, hard capsule
INN or Proposed INN: INDACATEROL MALEA
Sponsors
Novartis Pharma Services AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Patients who have signed Informed Consent Form prior to initiation of any study-related procedure. - Male and female adults aged = 40 years. - Patients with moderate to severe airflow obstruction with stable COPD (Stage 2 or Stage 3)according to the 2014 GOLD Guidelines. - Patients with a post-bronchodilator FEV1 =40 and =65 years) yes F.1.3.1 Number of subjects for this age range 700
Exclusion criteria
Exclusion criteria: - Patients who have not achieved acceptable spirometry results at Visit 101 in accordance with ATS (American Thoracic Society)/ERS (European Respiratory Society) criteria for acceptability (one retest may be performed for patients that don’t meet the acceptability criteria) - Patients who have had more than one COPD exacerbation that required treatment with antibiotics and/or oral corticosteroids and/or hospitalization in the last year prior to Visit 1. - Patients who developed a COPD exacerbation of any severity either 6 weeks before the screening (Visit 1) or between screening (Visit 1) and treatment (Visit 201) 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate the non-inferiority of QVA149 (110/50 µg o.d.) on trough FEV1 vs. tiotropium (18 µg o.d.) + salmeterol/fluticasone propionate FDC (50/500 µg b.i.d.) after 26 weeks of treatment in moderate-to-severe COPD patients.;Secondary Objective: - To evaluate the effect of QVA149 (110/50 µg o.d.) compared with tiotropium (18 µg o.d.) + salmeterol/fluticasone propionate FDC (50/500 µg b.i.d.) over 26 weeks of treatment in terms of Rate of moderate or severe COPD exacerbations. - To evaluate the effect of QVA149 compared with tiotropium + salmeterol/fluticasone propionate FDC on: - Trough FEV1 and FVC over 26 weeks - Total score of the SGRQ-C after 12 and 26 weeks - Total score of the TDI after 12 and 26 weeks - Mean use of rescue therapy (number of puffs/day) and the percentage of days without rescue therapy over 26 weeks. - To assess the safety of QVA149 vs. tiotropium + salmeterol/fluticasone propionate FDC over 26 weeks (particularly with regard to ECG, laboratory tests, vital signs and adverse events) and tolerability (discontinuation due to adverse events).;Primary end point(s): Mean change from baseline in post-dose trough FEV1;Timepoint(s) of evaluation of this end point: week 26 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Rate of moderate to severe COPD exacerbations requiring treatment with systemic glucocorticosteroids and/or antibiotics at 26 weeks - Rate of moderate to severe COPD exacerbations requiring hospitalisation at 26 weeks - Trough FEV1 and FVC at 26 weeks - Total St. George's Respiratory Questionnaire score at 12 weeks and 26 weeks - Total Transitional Dyspnea Index score at 12 weeks and 26 weeks - Number of puffs of rescue medication at 26 weeks - HPA axis function at 26 weeks - Safety and tolerability at 26 weeks;Timepoint(s) of evaluation of this end point: week 12 and week 26 | — |
Countries
Argentina, Austria, Belgium, Bulgaria, Canada, Colombia, Croatia, Czech Republic, Denmark, Estonia, France, Germany, Greece, Guatemala, Hungary, Italy, Latvia, Lithuania, Mexico, Netherlands, Poland, Romania, Serbia, Slovakia, Spain, United Kingdom
Contacts
Public ContactClinical Trial Information Desk
Novartis Pharma AG
Outcome results
None listed