To assess the bronchodilation of three doses of formoterol fumarate (6 μg, 12 μg and 24 μg) twice daily (BID) administered via Pressair® compared to placebo and to open-label nebulized formoterol fumarate (20 μg and 40 μg).
This is a prospective, randomized, double-blind, 5-period incomplete unbalanced crossover, placebo and active comparator (open-label) controlled, multicenter clinical trial to assess the efficacy and safety of three doses of formoterol fumarate (6 μg, 12 μg and 24 μg) BID administered via Pressair® compared to placebo and to open-label formoterol fumarate (20 μg BID and 40 μg single dose) administered as an inhalation solution via a standard jet nebulizer (with a mouthpiece) connected to an air compressor (Perforomist® Inhalation Solution). The drug product is an inhalation powder comprising of micronized aclidinium bromide and micronized formoterol fumarate with α-lactose monohydrate as the carrier, presented in a breathactuated device-metered dry-powder inhaler (DPI). It has been approved under the trademarks of Genuair® and/or Pressair® in some territories.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
132
Oral Inhalation (by Pressair® Dry Powder Inhaler, DPI)
Oral Inhalation (via a standard jet nebulizer connected to an air compressor.
Oral Inhalation (by Pressair® Dry Powder Inhaler, DPI)
Research Site
Glendale, Arizona, United States
Research Site
Phoenix, Arizona, United States
Change From Baseline in Normalized Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC) Over the 12 h Period Immediately After Morning Study Drug Administration, AUC0-12/12h at Day 7 on Treatment
To assess the bronchodilation of 3 doses of formoterol fumarate (6 μg, 12 μg and 24 μg) twice daily (BID administered via Pressair® compared to placebo and to open-label nebulised formoterol fumarate(20 μg). Pre-dose spirometry was performed before the morning daily dose at Day 1 and Day 7 of each treatment period. Two sets of measurements were performed during the hour preceding the scheduled morning study drug administration, allowing approximately 30 minutes between them. Note: Perforomist® 40 μg treatment periods lasted for 1 day only. Hence, was not included in the calculation.
Time frame: Day 7: 30 min, 1 to 4 hours, 6 hours, 9 hours and 12 hours post-dose
Change From Baseline in FEV1 AUC0-6/6h at Day 1 on Treatment
To assess the bronchodilation of 3 doses of formoterol fumarate (6 μg, 12 μg and 24 μg) BID administered via Pressair® compared to placebo and to open-label nebulised formoterol fumarate (20 μg and 40 μg). 6-hour serial spirometry was performed at Day 1 of each treatment period: spirometry was performed post-dose at 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours and 6 hours post-dose.
Time frame: Day 1: zero time to 6 hours post-dose
Change From Baseline in FEV1 AUC0-6/6h at Day 7 on Treatment
To assess the bronchodilation of 3 doses of formoterol fumarate (6 μg, 12 μg and 24 μg) BID administered via Pressair® compared to placebo and to open-label nebulised formoterol fumarate (20 μg). 6-hour serial spirometry was performed at Day 7 of each treatment period: spirometry was performed post-dose at 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours and 6 hours post-dose Note: Perforomist® 40 μg treatment periods lasted for 1 day only. Hence, was not included in the calculation
Time frame: Day 7: zero time to 6 hours post-dose
Change From Baseline in Morning Pre-dose (Trough) FEV1 at Day 7 on Treatment
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Oral Inhalation (by Pressair® Dry Powder Inhaler, DPI)
Oral Inhalation (via a standard jet nebulizer connected to an air compressor.
Research Site
Tempe, Arizona, United States
Research Site
Celebration, Florida, United States
Research Site
Clearwater, Florida, United States
Research Site
DeLand, Florida, United States
Research Site
Orlando, Florida, United States
Research Site
Lawrenceville, Georgia, United States
Research Site
St Louis, Missouri, United States
Research Site
Las Vegas, Nevada, United States
...and 10 more locations
To assess the bronchodilation of 3 doses of formoterol fumarate (6 μg, 12 μg and 24 μg) BID administered via Pressair® compared to placebo and to open-label nebulised formoterol fumarate (20 μg). Trough value was defined as the mean of the 2 pre-dose measurements on Day 7. If 1 of the 2 measurements was missing, the non-missing measurement was used as the trough value. Note: Perforomist® 40 μg treatment periods lasted for 1 day only. Hence, was not included in the calculation.
Time frame: At baseline and Day 7