The purpose of this study is to provide long term safety data of QVM149 in Japanese patients with asthma for the registration of QVM149 in Japan.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
96
QVM149 (indacaterol acetate/glycopyrronium bromide/mometasone furoate)
Novartis Investigative Site
Koga, Fukuoka, Japan
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs)
An adverse event (AE) was any untoward medical occurrence (example; any unfavorable and unintended sign including abnormal laboratory findings, symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study until the end of study visit. TEAEs were defined as adverse events started on or after the time of the first inhalation of study drug but no later than 7 days after the last administration (30 days in the case of SAEs). SAE was defined as any adverse event (appearance of \[or worsening of any pre-existing\]) undesirable sign, symptom or medical conditions which is fatal or life-threatening or results in persistent or significant disability/incapacity or constitutes a congenital anomaly/birth defect or requires inpatient hospitalization or prolongation of existing hospitalization or is medically significant.
Time frame: Up to 52 Weeks
Change From Baseline (Pre-dose) Forced Expiratory Volume in One Second (FEV1) at Week 26 and 52
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. Change from baseline in FEV1 at week 26 and 52 was reported.
Time frame: Baseline (Pre-dose), Week 26, Week 52
Change From Baseline (Pre-dose) Forced Vital Capacity (FVC) at Week 26 and 52
Forced Vital Capacity is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. FVC was assessed by spirometry. Change from baseline in FVC at week 26 and 52 was reported.
Time frame: Baseline (Pre-dose), Week 26, Week 52
Change From Baseline in Morning and Evening Peak Expiratory Flow (PEF) Over 52 Weeks
PEF is the peak expiratory flow, the maximum speed of expiration. Electronic peak flow meter (ePEF) was given to each participant at visit 1 for the measurement of morning and evening PEF. Change from baseline in morning and evening PEF over 52 weeks was measured.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Novartis Investigative Site
Yanagawa, Fukuoka, Japan
Novartis Investigative Site
Maebashi, Gunma, Japan
Novartis Investigative Site
Hiroshima, Hiroshima, Japan
Novartis Investigative Site
Sapporo, Hokkaido, Japan
Novartis Investigative Site
Tomakomai, Hokkaido, Japan
Novartis Investigative Site
Takamatsu, Kagawa-ken, Japan
Novartis Investigative Site
Fujisawa, Kanagawa, Japan
Novartis Investigative Site
Sagamihara, Kanagawa, Japan
Novartis Investigative Site
Sagamihara, Kanagawa, Japan
...and 15 more locations
Time frame: Baseline up to week 52
Change From Baseline in Asthma Control Questionnaire-7 (ACQ-7) Total Score at Week 26 and 52
ACQ-7 is a 7-item, disease-specific instrument developed and validated to assess asthma control in participants. All 7 items were scored on a 7-point Likert scale, with 0 indicating total control of asthma and 6 indicating poor control of asthma. The questions were equally weighted and the total score is the mean of the 7 items. A decrease of ACQ-7 score of at least 0.5 from baseline was considered to be clinically meaningful improvement.
Time frame: Baseline, Week 26, Week 52
Proportion of Participants Who Achieved Clinically Meaningful Improvement Threshold in ACQ-7 Score (Decrease of Greater Than or Equal to 0.5 Units in ACQ-7) at Week 26 and 52
ACQ-7 is a 7-item, disease-specific instrument developed and validated to assess asthma control in participants. All 7 items were scored on a 7-point likert scale, with 0 indicating total control of asthma and 6 indicating poor control of asthma. Questions were equally weighted and total score is mean of 7 items. A decrease from baseline of at least 0.5 units in ACQ-7 score was considered to be clinically meaningful improvement. The proportion of participants achieving the clinically meaningful improvement threshold in ACQ-7 score were reported at Week 26 and Week 52.
Time frame: Week 26, Week 52
Change From Baseline in Daily Number of Puffs of Rescue Medication Over 52 Weeks
Daily use of rescue medication (number of puffs taken in the previous 12 hours) were recorded each morning and evening throughout the 52 week treatment by the participant using their electronic diary.
Time frame: Baseline up to week 52