Investigation on the Cardiovascular and Pharmacokinetic Interaction Between Oral Roflumilast and Inhaled Formoterol in Healthy Subjects
Sponsor study identifier
interventional
27
1 country
1
Study Start
April 2004
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
July 2004
Actual (reported)Study Completion
December 2004
Actual (reported)This Phase I, open, randomized controlled, multiple-dose, parallel-group study investigated the potential pharmacodynamic and pharmacokinetic interactions between multiple doses of oral roflumilast and inhaled formoterol. Healthy male subjects were assigned to treatment A or treatment B. Subjects in treatment A received 500 μg/d roflumilast from day 2 to day 18 and 48 μg/d formoterol from day 12 to day 18. Subjects in treatment B received 48 μg/d formoterol from day 2 to day 18 and 500 μg/d roflumilast from day 9 to day 18. Impedance cardiography, ECG, serum potassium and glucose concentrations and effects on blood eosinophils assessed potential pharmacodynamic interactions. In addition, the safety and tolerability were evaluated. Pharmacokinetic parameters were assessed for roflumilast, roflumilast N-oxide, and formoterol.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2004
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 2004
Date type not reportedThis date has not been verified as actual or estimated.
July 2004
Actual (reported)December 2004
Actual (reported)July 3, 2009
Actual (reported)July 16, 2009
Actual (reported)Potential cardiovascular interaction (exploratory)
Potential pharmacokinetic interactions and potential pharmacodynamic interactions
Safety and tolerability of the monotreatments and the combination treatment (exploratory)
Treatment A (500 μg/d roflumilast from day 2 to day 18 and 48 μg/d formoterol from day 12 to day 18)
Treatment B (48 μg/d formoterol from day 2 to day 18 and 500 μg/d roflumilast from day 9 to day 18)
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Nycomed
Konstanz, 78467, Germany
de Mey C, Nassr N, Lahu G. No relevant cardiac, pharmacokinetic or safety interactions between roflumilast and inhaled formoterol in healthy subjects: an open-label, randomised, actively controlled study. BMC Clin Pharmacol. 2011 Jun 1;11:7. doi: 10.1186/1472-6904-11-7.
AstraZeneca AstraZeneca
AstraZeneca
27 participants (actual enrollment reported by the registry).
First Submitted
July 3, 2009
First Posted
July 16, 2009
Study Start
April 2004
Date type not reportedThis date has not been verified as actual or estimated.
A Study to Assess the Lung Exposure Bioequivalence of Budesonide, Glycopyrronium, & Formoterol (BGF) Metered Dose Inhaler (MDI) With a Next-generation Propellant (NGP) With a Spacer, BGF MDI Hydrofluoroalkane (HFA) With a Spacer, as Well as BGF MDI NGP Without a Spacer
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Primary Completion
July 2004
Actual (reported)Study Completion
December 2004
Actual (reported)Last Updated
December 2, 2016
Record last verified: 2016-09
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Source: ClinicalTrials.gov.
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