This study will evaluate the onset of action of indacaterol (150 and 300 µg) as compared to placebo, salbutamol 200 µg and salmeterol/fluticasone 50/500 µg
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
89
Indacaterol 150 and 300 μg, delivered via single-dose dry-powder inhaler (SDDPI)
Salmeterol/fluticasone 50/500 μg fixed-dose combination delivered via manufacturer's proprietary Multi-Dose Dry-Powder Inhaler (MDDPI).
Salbutamol 200 μg delivered via manufacturer's proprietary Multi-Dose Dry-Powder Inhaler (MDDPI).
Novartis Investigative Site
Tamarac, Florida, United States
Novartis Investigator Site
Lafayette, Louisiana, United States
Novartis Investigative Site
Forced Expiratory Volume in 1 Second (FEV1) at 5 Minutes Post-dose
FEV1 was measured at 5 minutes after dosing with spirometry conducted according to internationally accepted standards. The time of dosing was defined as the time corresponding to the use of the first inhaler device. The primary variable was analyzed using a mixed model containing the period baseline FEV1 as covariate. The period baseline FEV1 was the average of the FEV1 value measured in the clinic at 50 and 15 min prior to the study drug administration in that period.
Time frame: Five Minutes Post Dose
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Placebo to indacaterol delivered via SDDPI
Placebo to salmeterol/fluticasone delivered via MDDPI
Placebo to salbutamol delivered via MDDPI
Saint Charles, Missouri, United States
Novartis Investigative site
Shelby, North Carolina, United States
Novartis Investigative Site
Beaver, Pennsylvania, United States
Novartis Investigative Site
Antwerp, Belgium
Novartis Investigative Site
Berlin, Germany
Novartis Investigator Site
Borstel, Germany
Novartis Investigative site
Dortmund, Germany
Novartis Investigative site
Hamburg, Germany
...and 7 more locations