Study of QMF149 (150/80 µg) Compared With MF Twisthaler® (200 µg) in Patients With Asthma
|ClinicalTrials.gov Identifier: NCT02892344|
Recruitment Status : Completed
First Posted : September 8, 2016
Results First Posted : September 12, 2019
Last Update Posted : September 12, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Mild Asthma||Drug: QMF149 150/80 μg Drug: MF 200 μg||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||802 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||A Multi-center, Randomized, 12-week Treatment, Doubleblind Study to Assess the Efficacy and Safety of QMF149 (150/80 Microgram) Compared With MF Twisthaler® (200 Microgram) in Adult and Adolescent Patients With Asthma|
|Actual Study Start Date :||January 16, 2017|
|Actual Primary Completion Date :||November 5, 2018|
|Actual Study Completion Date :||November 30, 2018|
Experimental: QMF149 150/80 μg
QMF149 150/80 microgram o.d. delivered via Concept1
Drug: QMF149 150/80 μg
QMF149 150/80 μg o.d via Concept1
Other Name: Indacaterol acetate/Mometasone furoate
Active Comparator: MF 200 µg
MF 200 microgram o.d. delivered via Twisthaler®
Drug: MF 200 μg
MF 200 μg o.d. via Twisthaler®
Other Name: Mometasone furoate
- Trough FEV1 [ Time Frame: week 12 ]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.
- ACQ-7 [ Time Frame: week 12 ]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.
- Trough FEV1 at Day 2 [ Time Frame: 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
- Pre-dose FEV1 at Week 4 [ Time Frame: week 4 ]Pre-dose FEV1 is defined as the mean of -45 min and -15 min FEV1 values pre-evening dose
- FVC Over 12 Weeks [ Time Frame: week 12 ]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
- PEF Over 4 and 12 Weeks [ Time Frame: week 12 ]Morning and Evening Peak Expiratory Flow Rate (PEF) will be measured. PEF is the peak expiratory flow, the maximum speed of expiration
- Percentage of Patients With ACQ-7 MID at Week 12 [ Time Frame: 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.
- Daily E-diary Over 12 Weeks [ Time Frame: week 12 ]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
- ACQ-7 at Week 4 [ Time Frame: 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
- Rescue Medication Use Over 12 Weeks [ Time Frame: week 12 ]Rescue salbutamol/albuterol usage (mean daily, nighttime and daytime use) from e-Diary recordings over 12 weeks of treatment
- Percentage of Rescue Medication Free Days Over 12 Weeks [ Time Frame: week 12 ]Percentage of rescue medication free days over 12 weeks of treatment period
- Quality of Life Assessed by Asthma Quality of Life Questionnaire AQLQ-S 12 [ Time Frame: week 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.
- Number of Patients With Asthma Exacerbation Over 12 Weeks [ Time Frame: Week 12 ]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.
- The Number of Asthma Exacerbations (Moderate or Severe) Over the 12 Week Treatment Period [ Time Frame: Week 12 ]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
- Number of Patients With First Asthma Exacerbations (Moderate or Severe) Over the 12 Week Treatment Period [ Time Frame: Week 12 ]The annual rate of asthma exacerbations were analyzed using a generalized linear model.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02892344