Indacaterol
DrugIndacaterol 150 and 300 μg, delivered via single-dose dry-powder inhaler (SDDPI)
Other names: Arcapta, Neohaler
NCT Number: NCT00669617
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
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Notify Me40 year and older
All sexes
Interventional
Phase 3
Novartis Investigative Site, Antwerp, Belgium
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Other protocol-defined inclusion/exclusion criteria may apply
Indacaterol 150 and 300 μg, delivered via single-dose dry-powder inhaler (SDDPI)
Other names: Arcapta, Neohaler
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).
Placebo to indacaterol delivered via SDDPI
Placebo to salmeterol/fluticasone delivered via MDDPI
Placebo to salbutamol delivered via MDDPI
Time frame: Five 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.
Novartis
Industry
A Phase III, Randomized, Double-blind, Triple-dummy, Placebo Controlled, Multicenter, 5-period, Single-dose Complete Block Crossover Study to Determine the Onset of Action of Indacaterol (150 and 300 μg) in Patients With Moderate to Severe COPD Using Salbutamol (200 μg) and Salmeterol/Fluticasone (50/500 μg) as Active Controls
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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