The purpose of the trial was to evaluate efficacy and safety of QMF149 150/80 microgram o.d. delivered via Concept1 compared to MF 200 microgram o.d., delivered via Twisthaler® in terms of lung function and symptom control in poorly (ie inadequately) controlled asthma patients. This study was to assess contribution of LABA as an add-on therapy to low dose ICS monotherapy.
The primary objective of this study was to demonstrate the superiority of QMF149 150/80 microgram o.d. (in the evening) delivered via Concept1 compared with MF 200 microgram o.d. (in the evening) delivered via Twisthaler® in terms of trough FEV1 after 12 weeks of treatment in adults and adolescents. The key secondary objective of this study was to demonstrate the superiority of QMF149 150/80 microgram to MF 200 microgram o.d. in terms of ACQ-7 after 12 weeks of treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
802
QMF149 150/80 μg o.d via Concept1
MF 200 μg o.d. via Twisthaler®
Trough FEV1
demonstrate the superiority of QMF149 150/80 microgram o.d. (in the evening) delivered via Concept1 compared with MF 200 microgram o.d. (in the evening) delivered via Twisthaler® in terms of trough FEV1 after 12 weeks of treatment in adults and adolescents. Forced Expiratory Volume in 1 second (FEV1) is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation, measured by spirometry.
Time frame: week 12
ACQ-7
ACQ-7 is an asthma control questionnaire (scoring 5 symptoms, FEV1 entered by the investigator and daily rescue bronchodilator use entered by the patient) validated to evaluate different levels of asthma control. the ACQ-7 was used to assess improvements in asthma symptom control. The ACQ-7, a seven-item disease-specific instrument developed and validated to assess asthma control in patients in clinical trials as well as in individuals in clinical practice, was provided to the site. All seven items were then scored on a 7-point Likert scale, with 0 indicating total control and 6 indicating no control. The questions were equally weighted and the total score was the mean of the seven items. The first 6 questions of the ACQ-7 were completed by the patient while the last question (question 7) was completed by the study investigator using spirometry data generated by the spirometry equipment.
Time frame: week 12
Trough FEV1 at Day 2
Forced Expiratory Volume in 1 second (FEV1) is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation, measured through spirometry testing
Time frame: Day 2
Pre-dose FEV1 at Week 4
Pre-dose FEV1 is defined as the mean of -45 min and -15 min FEV1 values pre-evening dose
Time frame: week 4
FVC Over 12 Weeks
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Novartis Investigative Site
Bulgaria, Bulgaria, Bulgaria
Novartis Investigative Site
Stara Zagora, Bulgaria, Bulgaria
Novartis Investigative Site
Pleven, Bulgaria
Novartis Investigative Site
Santiago, Santiago Metropolitan, Chile
Novartis Investigative Site
Santiago, Chile
Novartis Investigative Site
Santiago, Chile
Novartis Investigative Site
Viña del Mar, Chile
Novartis Investigative Site
Medellín, Antioquia, Colombia
Novartis Investigative Site
Bucaramanga, Colombia, Colombia
Novartis Investigative Site
Medellín, Colombia, Colombia
...and 113 more locations
FVC is the total amount of air exhaled during the FEV test. Forced Vital Capacity (FVC) and Forced Expiratory Flow between 25% and 75% of FVC (FEF25-75) will be measured
Time frame: week 12
PEF Over 4 and 12 Weeks
Morning and Evening Peak Expiratory Flow Rate (PEF) will be measured. PEF is the peak expiratory flow, the maximum speed of expiration
Time frame: week 12
Percentage of Patients With ACQ-7 MID at Week 12
MID is Minimum Important Difference. ACQ-7 is an asthma control questionnaire (scoring 5 symptoms, FEV1 entered by the investigator and daily rescue bronchodilator use entered by the patient) validated to evaluate different levels of asthma control. Percent of patients achieving the minimal important difference (MID) in ACQ-7 (i.e. at least 0.5 decrease from baseline) will be measured.
Time frame: week 12
Daily E-diary Over 12 Weeks
Percentage of asthma symptoms free days, the percentage of nights without nighttime awakenings, and the percentage of mornings without symptoms on awakening as recorded by daily electronic Diary (e-Diary) over 12 weeks of treatment
Time frame: week 12
ACQ-7 at Week 4
ACQ-7 is an asthma control questionnaire (scoring 5 symptoms, FEV1 entered by the investigator and daily rescue bronchodilator use entered by the patient) validated to evaluate different levels of asthma control
Time frame: week 4
Rescue Medication Use Over 12 Weeks
Rescue salbutamol/albuterol usage (mean daily, nighttime and daytime use) from e-Diary recordings over 12 weeks of treatment
Time frame: week 12
Percentage of Rescue Medication Free Days Over 12 Weeks
Percentage of rescue medication free days over 12 weeks of treatment period
Time frame: week 12
Quality of Life Assessed by Asthma Quality of Life Questionnaire AQLQ-S 12
The AQLQ is a 32-item disease specific questionnaire designed to measure functional impairments in asthma. Patients are asked to score each item on a 7-point scale based on the experience of last 2 weeks. The overall AQLQ score is the mean response to all 32 questions. Therefore, the possible highest score (better) would be 7 and the lowest (worse) would be 1. Changes in scores of 0.5 to 1.0 are considered clinically meaningful; 1.0 to 1.5 as moderate and \> 1.5 as marked clinically important differences for any individual domain or for the overall summary score.
Time frame: week 12
Number of Patients With Asthma Exacerbation Over 12 Weeks
The exacerbation categories are: mild, moderate, severe and the combination of moderate or severe. Time to first asthma exacerbation by exacerbation category. Annual rate of asthma exacerbations by exacerbation category.
Time frame: Week 12
The Number of Asthma Exacerbations (Moderate or Severe) Over the 12 Week Treatment Period
Annual incidence rate of asthma exacerbation by severity of exacerbation. The number of asthma exacerbation is used to calculate annual incidence rate. A severe asthma exacerbation is SCS (Systemic Corticosteroids) use ≥3 days and hospitalization or emergency department visit (greater than 24 h) or death due to asthma. A moderate asthma exacerbation is SCS use ≥3 days either as an outpatient or in emergency department visits (less than or equal to 24 h). Worsening of asthma not requiring more than 3 days of SCS or hospitalization/emergency room will be considered mild asthma exacerbations
Time frame: Week 12
Number of Patients With First Asthma Exacerbations (Moderate or Severe) Over the 12 Week Treatment Period
The annual rate of asthma exacerbations were analyzed using a generalized linear model.
Time frame: Week 12