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 de
Sponsors
Novartis Pharma AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Male and female adult patients = 18 years old and = 75 years. • Patients with a documented physician diagnosis of asthma for a period of at least 12 months prior to Visit 1 (Screening). • Patients who have used ICS and LABA combinations for asthma for at least 3 months and at a stable medium or high dose of ICS for at least 1 month prior to Visit 1 (Screening). • Pre-bronchodilator FEV1 of =65 years) yes F.1.3.1 Number of subjects for this age range 9
Exclusion criteria
Exclusion criteria: Patients who have smoked or inhaled tobacco products within the 6 month period prior to Visit 1 • Patients who have had an asthma attack/exacerbation requiring systemic steroids or hospitalization or emergency room visit within 6 weeks of Visit 1 • Patients with narrow-angle glaucoma, symptomatic benign prostatic hyperplasia (BPH) or bladder-neck obstruction or severe renal impairment or urinary retention • Patients who have had a respiratory tract infection or asthma worsening within 4 weeks prior to Visit 1 • Patients with any chronic conditions affecting the upper respiratory tract • Patients with a history of chronic lung diseases other than asthma, including (but not limited to) COPD, sarcoidosis, interstitial lung disease, cystic fibrosis, clinically significant bronchiectasis and active tuberculosis. • Patients with Type I diabetes or uncontrolled Type II diabetes (HbA1c >9% at screening). • Patients who have a clinically significant ECG abnormality at Visit 1 • Patients with a history of hypersensitivity or intolerance to any of the study drugs (including excipients) • Patients with narcolepsy and/or insomnia. • Patients on Maintenance Immunotherapy (desensitization) for allergies for less than 3 months prior to Visit 2 or patients on Maintenance Immunotherapy for more than 3 months prior to Visit 2 but expected to change throughout the course of the study. • Pregnant or nursing (lactating) women • Women of child-bearing potential must use Highly effective contraception methods • Patients who have discontinued LAMA therapy in the past for any safety, tolerability or perceived lack of efficacy reason. • History of paradoxical bronchospasm in response to inhaled medicines. • Patients with a history of clinically relevant bronchoconstriction upon repeated forced expiratory maneuvers. • Patient with a serum potassium level below the laboratory limit of normal at screening.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: •To demonstrate superiority in peak bronchodilator effect of QVM149 at a dose of 150/50/160 µg o.d. and 150/50/80 µg o.d. compared to a FDC of salmeterol/fluticasone at a dose of 50/500 µg b.i.d. after 3 weeks of treatment in patients with asthma;Secondary Objective: •To evaluate the bronchodilator effect of each dose of QVM149 compared to salmeterol/fluticasone FDC after 3 weeks of treatment. •To evaluate the bronchodilator effect of each dose of QVM149 compared to salmeterol/ fluticasone FDC by measuring standardized FEV1 AUCs after 3 weeks of treatment respective period. •To evaluate post-dose trough bronchodilator effect of each dose of QVM149 compared to salmeterol/fluticasone FDC after 3 weeks of treatment in the respective treatment period.;Primary end point(s): Peak FEV1 (mL) defined as the highest bronchodilatory effect on FEV1 during a period of 5 min to 4 h after the last evening dose of each treatment period.;Timepoint(s) of evaluation of this end point: 3 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • FEV1, Forced Vital Capacity (FVC), and FEV1/FVC ratio at timepoints in relation to evening dose. • FEV1AUC 5 min - 1 h (Day 21), FEV1AUC 5 min - 4 h (Day 21) FEV1AUC 5 min (Day 21) - 23 h 45 min (Day 22) • Trough FEV1 (mL; mean of FEV1 at 23 h 15 min and 23 h 45 min post-dose);Timepoint(s) of evaluation of this end point: 3 weeks | — |
Countries
Bulgaria, China, Germany, Netherlands, Romania, United Kingdom
Contacts
Public ContactClinical Trial Information Desk
Novartis Pharma AG
Outcome results
None listed