None listed
Conditions
Interventions
Group 1 Type of group
QMF149 Twisthaler® (indacaterol maleate 500 µg/mometasone furoate 400 µg), once daily (QD)
Group name:Group 2 Type of group
Mometasone Twisthaler®, 400 µg QD
Sponsors
NOVARTIS BIOSCIENSES PERU S.A.,
Eligibility
Sex/Gender
All
Age
12 Years to 70 Years
Inclusion criteria
Inclusion criteria: • Patients must give written informed consent before any study related activity is performed Patients below the legal age of consent are required to have the Informed Consent Form signed by the patient’s parent/guardian; adolescents should also sign an assent form • Male and female adult and adolescent patients aged =12 years (or =18 years depending upon regulatory and/or IRB/IEC/REB approval and/or country participation) and = 70 years • Patients with a documented diagnosis of persistent asthma (according to GINA guidelines) for a period of at least 6 months prior to Visit 1 and who are currently treated with or qualify for treatment (according to asthma treatment guidelines) with both ICS and LABA combination. • Patients demonstrating an increase in FEV1 of =12% or =200 mLs within 30 minutes after administration of ß2-agonist (SABA) as per site protocol. Alternatively, patients may have documentation of reversibility within the last 12 months • Patients with an FEV1 =50% of predicted normal at Visit 2. This criterion for FEV1 will have to be demonstrated after all restricted medications have been withheld for appropriate intervals (washout period of at least 6 hours for a short acting ß2-agonist and a minimum of 24 hours for a long acting ß2-agonist).
Exclusion criteria
Exclusion criteria: • Pregnant or nursing (lactating) women confirmed by a positive serum hCG laboratory test (> 5 IU/ml) • Women of child-bearing potential (WOCBP), including women whose career, lifestyle, or sexual orientation precludes intercourse with a male partner and women whose partners have been sterilized by vasectomy or other means, UNLESS they meet the following definition of post-menopausal • Patients who have smoked or inhaled tobacco products within the 3 month period prior to Visit 2, or who have a smoking history of greater than 10 pack years • Patients with a previous diagnosis of COPD • Patients who have had a asthma attack/exacerbation requiring hospitalization within 1 month prior to Visit 3 • Patients who have had an emergency room visit for an asthma attack/asthma exacerbation within 1 month prior to Visit 3 • Patients who have had a respiratory tract infection or asthma worsening within 1 month prior to Visit 3. • Patients who have ever required ventilator support for respiratory failure secondary to asthma • Patients with evidence upon visual inspection of clinically significant oropharyngeal candidiasis at baseline or earlier, with or without treatment. • Patients with any chronic conditions affecting the respiratory tract or chronic lung diseases which may interfere with the study evaluation or optimal participation in the study • Patients with diabetes Type I or uncontrolled diabetes Type II • Patients who have a clinically relevant laboratory abnormality or a clinically significant condition that might compromise patient safety or compliance, interfere with evaluation, or preclude completion of the study • Any patient with active cancer or a history of cancer with less than 5 years disease free survival time • Patients with a history of long QT syndrome or whose QTc interval (Fridericia) measured at Visit 2 or Visit 3 is prolonged: >450 ms as assessed by the central ECG interpretation (Visit 2) or investigator’s interpretation of the pre-dose ECGs (Visit 3). Patients who fail the screening ECG (with the exception of machine failures) should not be re-screened. • History of myocardial infarction within the previous 12 months; uncontrolled or unstable angina pectoris or arrhythmia (excluding chronic atrial fibrillation). Known history of congestive heart failure or known LVEF < 45%. Implanted cardiac pacemaker or defibrillator • Patients with a history of hypersensitivity to any of the study drugs or to similar drugs within the class including untoward reactions to sympathomimetic amines or inhaled medication or any component thereof. • Patients who do not maintain regular day/night, waking/sleeping cycles • Patients who have had live attenuated vaccinations within 30 days prior to screening visit or during the run-in period. • Patients using prohibited medications or patients who cannot adhere to medication washouts. • Maintenance Immunotherapy (desensitization) for allergies is allowed if maintenance dose has been administered for at least 3 months prior to Visit 2, and is expected to remain unchanged throughout the course of the study • Other excluded medications
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Defined as the number of days from start of treatment up to the first date when an asthma exacerbation becomes serious. A serious asthma exacerbation was one that resulted in hospitalization, intubation or death. Measure:Time to First Serious Asthma Exacerbation Timepoints:Up to 21 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:The number of patients with at least one serious asthma exacerbation over the course of the study. A serious asthma exacerbation was one that resulted in hospitalization, intubation or death. Measure:Cumulative Incidence of the First Serious Asthma Exacerbation Resulting in Hospitalization, Intubation or Death. Timepoints:up to 21 months ; Outcome name:Number of patients requiring treatment with systemic corticosteroids (oral or parenteral) over the course of the study (up to 21 months). Measure:Patients With Asthma Exacerbations That Required Treatment With Systemic Corticosteroids Timepoints:Up to 21 months ; Outcome name:The criterion for asthma worsening were: decrease in peak expiratory flow (PEF) >= 20% from mean baseline on >= 3 consecutive days, nighttime symptom score >= 2 on >= 2 consecutive nights, decrease in forced expiration volume in 1 second (FEV1) >=20% from baseline at evening visits, daytime symptom score of 3 or 4 on >= 2 consecutive days, requiring an urgent unscheduled visit for medical care, 24 hour rescue medication use >= 8 puffs on >= 2 consecutive days, and any other clinically important symptoms (pre-specified MedDRA preferred terms). Measure:Number of Patients With at Least One Asthma Worsening Post-baseline Timepoints:Up to 21 months ; Outcome name:Spirometry was conducted according to internationally accepted standards. Trough FEV1 was measured 15 minutes before dosing; measurements within 6 hours of rescue medication use were set to missing. Repeated measures of analysis of covariance model: change from baseline to trough FEV1 = treatment + visit + treatment*visit interaction + baseline FEV1 + region + asthma related hospitalization in the last 12 months + asthma worsening in the last 12 months + African American patient. Measure:Change From Baseline in Trough Forced Expiration Volume in 1 Second (FEV1) at Final Visit Timepoints:Baseline to the end of treatment (var | — |
Countries
Czech Republic, Hungaria, Peru
Contacts
Public ContactCrisitan Barrenechea
NOVARTIS BIOSCIENCES PERU S.A.
Outcome results
None listed