Asthma MedDRA version: 20.0 Level: PT Classification code 10003553 Term: Asthma System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Conditions
Interventions
Product Name: Indacaterol acetate/Glycopyrronium bromide/mometasone furoate
Product Code: QVM149
Pharmaceutical Form: Inhalation powder, hard capsule
INN or Proposed INN: INDACATEROL ACETATE
Other des
Sponsors
Novartis Pharma AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Patients with a diagnosis of asthma for a period of at least 6 months prior to Visit 1 with current asthma severity = step 4 (GINA 2017). - Patients who have used ICS/LABA combinations for asthma for at least 3 months and at stable medium or high dose of ICS/LABA for at least 1 month prior to Visit 1. - Patients must be symptomatic at screening despite treatment with medium or high stable doses of ICS/LABA as defined by ACQ-7 score = 1.5 at visits 101 and 201 (randomization visit). - Patients with history of at least one severe asthma exacerbation which required medical care from a physician, ER visit (or local equivalent structure) or hospitalization in the 12 months prior to Visit 1 and required systemic corticosteroid treatment for at least 3 days including physician guided self-management treatment with oral corticosteroids as part of written asthma action plan. - Pre-bronchodilator FEV1 of =65 years) yes F.1.3.1 Number of subjects for this age range 300
Exclusion criteria
Exclusion criteria: - Patients who have a smoking history of greater than 20 pack years. - Patients diagnosed with Chronic Obstructive Pulmonary Disease (COPD). - Patients who have had an asthma attack/exacerbation requiring systemic steroids or hospitalization or emergency room visit within 6 weeks of Visit 1 (Screening). - Patients treated with a LAMA for asthma within 3 months prior to Visit 1. - Patients who have had a respiratory tract infection or clinical significant asthma worsening as defined by Investigator within 4 weeks prior to Visit 1 or between Visit 1 and Visit 201.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate that the efficacy of two treatment arms of the fixed-dose combination product QVM149 is non-inferior to the efficacy of the free combination arm of salmeterol/fluticasone + tiotropium in uncontrolled asthmatics.;Primary end point(s): Change from baseline in Asthma Quality of Life Questionnaire (AQLQ) total score;Timepoint(s) of evaluation of this end point: 24 weeks;Secondary Objective: - To evaluate efficacy of QVM149 high-dose and QVM149 medium-dose compared to salmeterol/ fluticasone + tiotropium in terms of Trough FEV1 after 24 weeks of treatment. - To evaluate efficacy of QVM149 high-dose and QVM149 medium-dose compared to salmeterol/ fluticasone + tiotropium in terms of Asthma Quality of Life Questionnaire over 24 weeks of treatment. - To evaluate efficacy of QVM149 high-dose and QVM149 medium-dose compared to salmeterol/ fluticasone + tiotropium in terms of Asthma Control Questionnaire over 24 weeks of treatment. - To evaluate efficacy of QVM149 high-dose and QVM149 medium-dose compared to salmeterol/ fluticasone + tiotropium in terms of lung function over 24 weeks of treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Change from baseline in Trough FEV1 - Change from baseline in Asthma Control Questionnaire (ACQ-7) total score - Change from baseline in Asthma Quality of Life Questionnaire (AQLQ) total score - Percentage of patients achieving the minimal important difference (MCID) change from baseline ACQ-7 = 0.5 decrease - Percentage of patients achieving the minimal important difference (MCID) change from baseline AQLQ = 0.5 increase - Change from baseline in Forced Vital Capacity (FVC) - Change from baseline in Forced Expiratory Flow between 25% and 75% of Forced Vital Capacity (FEF25-75);Timepoint(s) of evaluation of this end point: - 8 weeks, 16 weeks, 24 weeks - 16 weeks, 24 weeks - 16 weeks - 16 weeks, 24 weeks - 16 weeks, 24 weeks - 8 weeks, 16 weeks, 24 weeks - 8 weeks, 16 weeks, 24 weeks | — |
Countries
Argentina, Brazil, Chile, China, Colombia, Czech Republic, Egypt, Germany, Greece, Hungary, India, Israel, Italy, Mexico, Peru, Poland, Romania, Russian Federation, Serbia, Singapore, Slovakia, South Africa, Spain, Taiwan, Turkey, United Kingdom, Vietnam
Contacts
Public ContactVeronique Schaaf
Novartis (Hellas) S.A.C.I.
Outcome results
None listed