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CompletedNCT00940329Updated Dec 2, 2016

Pharmacodynamic/Pharmacokinetic Interactions Between Oral Roflumilast and Inhaled Formoterol

A Phase 1 interventional study of Roflumilast and Roflumilast in Healthy, sponsored by AstraZeneca. Completed at 1 site in Germany. Open to male participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-12-02.

Sponsored by AstraZeneca · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
27
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
Male
01

Study summary

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.

02

Conditions studied

  • Healthy

Keywords

  • Drug interactions
  • Pharmacodynamic interactions
  • Pharmacokinetic interactions
  • Formoterol
  • Healthy subjects
  • Phase I study
  • Roflumilast
03

In context

Lead sponsor

AstraZeneca is the lead sponsor of 3,429 studies on the registry; 270 are open to participants now.

Of its 357 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Inclusion criteria

  • Age between 18 and 45 years
  • Normal body weight as indicated by a Body Mass Index (BMI) between 18 and 30 kg/m2 and a body weight > 50 kg
  • Assessed as healthy, based on a screening examination including medical history, physical examination, BP, PuR, ECG, and clinical laboratory results
  • Caucasian

Exclusion criteria

Exclusion Criteria:

  • Suspected lack of compliance
  • Participant in any other study or donation of blood during the last 30 d before start of this study (last day of intake of medication - first day of medication in the following study)
  • Any active disease, acute or chronic (also psychiatric diseases)
  • Any signs or present history of cardiac diseases (e.g. QTc interval acc. to Bazett ≥ 430 ms, PQ ≥ 220 ms), in particular tachycardiac arrhythmia, third-degree AV-block, idiopathic-subvalvular aortic stenosis or hypertrophic-obstructive cardiomyopathia
  • Proneness to symptomatic orthostatic dysregulation, fainting or "blackouts" (medical history), or to orthostatic hypotension defined by SBP \< 90 mm Hg (standing blood pressure, 30 s after raising up from a supine position)
  • Gastrointestinal surgery except from appendectomy and herniotomy
  • HIV or hepatitis screening positive or not performed (in case of a positive HIV test, the subject had to be informed by a physician in personal communication
  • Drug screening positive or not performed
  • Excessive xanthine consumption (more than 5 cups of coffee or equivalent per day)
  • Non-compliance for measurements of impedance cardiography (feasibility was proven and documented at the screening visit by one test procedure)
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
27 participants (actual)

Study arms

  • Active comparator
    Treatment A

    Drug: Roflumilast

  • Active comparator
    Treatment B

    Drug: Roflumilast

Interventions

  • DrugRoflumilast

    Treatment A (500 μg/d roflumilast from day 2 to day 18 and 48 μg/d formoterol from day 12 to day 18)

  • DrugRoflumilast

    Treatment B (48 μg/d formoterol from day 2 to day 18 and 500 μg/d roflumilast from day 9 to day 18)

06

What researchers measure

Primary outcomes

  1. Potential cardiovascular interaction (exploratory)

Secondary outcomes

  1. Potential pharmacokinetic interactions and potential pharmacodynamic interactions

  2. Safety and tolerability of the monotreatments and the combination treatment (exploratory)

07

Study locations

1 site
  • Nycomed
    Konstanz, 78467, Germany
08

References and documents

Publications

  • 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. PubMed 21631929 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 2, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00940329
Lead sponsor
AstraZeneca
Responsible party
Sponsor
First posted
Jul 16, 2009
Start date
Apr 2004
Primary completion
Jul 2004
Completion
Dec 2004
Last update
Dec 2, 2016

Study contacts

AstraZeneca AstraZeneca
study director · AstraZeneca
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2016. You cannot join it, but the record below documents what was studied.

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