This was a randomized, placebo-controlled, double-blind, six-sequence, three-period cross-over study in asthma patients. The study consisted of a 14-day screening period, followed by a 14-day run-in period, and a treatment epoch which consists of three treatment periods, with a minimum duration of 14 days each followed (for the 2 first treatment periods) by a wash-out period. The duration of each treatment period may be extended up to a duration of 18 days if needed for operational reasons. The third treatment period was followed by a Study Completion evaluation at 1-7 days following the last dose. The treatment periods were separated by wash-out periods of 14 to 21 days duration.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
38
Matching placebo (morning dose) and QVM149 150/50/80 μg (evening dose)
QVM149 150/50/80 μg (morning dose) and matching placebo (evening dose)
Placebo (morning dose) and placebo (evening dose)
Novartis Investigative Site
Berlin, Germany
Novartis Investigative Site
Frankfurt Am Main Hessen, Germany
Novartis Investigative Site
Großhansdorf, Germany
Novartis Investigative Site
Hanover, Germany
Novartis Investigative Site
Wiesbaden, Germany
Novartis Investigative Site
Groningen, GZ, Netherlands
Novartis Investigative Site
Machester, United Kingdom
FEV1 Standardized Area Under the Curve (AUC 0-24h) After Last Evening Dose of 14-day Treatment Period
Weighted mean forced expiratory volume in 1 second (FEV1) over 24 h (AUC0-24h) following 14 days of treatment with QVM149 dosed in the morning, QVM149 dosed in the evening and placebo.
Time frame: At the end of each treatment period day 14 pre-dose to 24 hours post-dose.
Trough FEV1 After 24h
FEV1 at approximately 24 h after the last p.m. or penultimate a.m. dose. Morning and evening trough FEV1 (L) were analyzed by time of day. For morning trough FEV1 (L) assessments this meant that the spirometric assessment was done approximately 24 h after last morning dose and approximately 12 h after last evening dose.
Time frame: At the end of each treatment period day 14 pre-dose to 24 hours post-dose.
Peak Expiratory Flow (PEF)
Peak expiratory flow (PEF) is the maximum flow generated during a forceful exhalation, starting from full lung inflationDaily morning and evening peak expiratory flow rate from Day 2 to Day14 during the three treatment periods.
Time frame: From treatment period start through study completion (up to 19 weeks).
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