A Randomized, Double-blind, Double-dummy, Active (Formoterol 12 µg b.i.d) and Placebo Controlled, Multi-center, 5 Period Crossover Study to Assess the Bronchodilatory Efficacy and Safety of Single Doses of Indacaterol 150 µg, 300 µg and 600 µg Delivered Via Single Dose Dry Powder Inhaler vs. Placebo in Patients With Moderate to Severe COPD.
Sponsor study identifier
interventional
51
1 country
1
Study Start
October 2006
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
January 2007
Actual (reported)Study Completion
January 2007
Actual (reported)The study is designed to obtain safety and efficacy data on three dose levels of indacaterol when delivered via an SDDPI in patients with COPD. All patients will receive 1 day of treatment with each of the following: indacaterol 150 µg, once- indacaterol 300 µg, indacaterol 600 µg, placebo, and formoterol. Each treatment day will be followed by a washout-period of 1 week.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 2007
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 2006
Date type not reportedThis date has not been verified as actual or estimated.
November 6, 2006
Actual (reported)November 7, 2006
Actual (reported)January 2007
Actual (reported)January 2007
Actual (reported)Lung function measured 24 hours after having taken medication, by a special test called "forced expiratory volume in 1 second "(FEV1)
FEV1 at time points 30 min, 1, 2 and 4hours post-dose
Percent change in FEV1 at time points 30 min, 1, 2 and 4 hours, 23 hours 10min and 23 hours 45 min post dose
Forced vital capacity (FVC) at time points 30 min, 1, 2 and 4 hours, 23 hours 10 min and 23 hours 45 min post dose
Standardized FEV1 area under the curve (AUC) between baseline and 4 hours
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Novartis
Vilvoorde, Belgium
Hosoe M, Woessner R, Matsushima S, Lawrence D, Kramer B. Efficacy, safety and pharmacokinetics of indacaterol in Caucasian and Japanese patients with chronic obstructive pulmonary disease: a comparison of data from two randomized, placebo-controlled studies. Clin Drug Investig. 2011;31(4):247-55. doi: 10.2165/11586520-000000000-00000.
Novartis
Novartis
51 participants (actual enrollment reported by the registry).
First Submitted
November 6, 2006
First Posted
November 7, 2006
Study Start
October 2006
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Primary Completion
January 2007
Actual (reported)Study Completion
January 2007
Actual (reported)Last Updated
October 25, 2011
Record last verified: 2011-10
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Source: ClinicalTrials.gov.
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