NCT00940329

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at P25-P50 for phase_1 healthy

Timeline
Completed

Started Apr 2004

Typical duration for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2004

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2004

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2004

Completed
4.6 years until next milestone

First Submitted

Initial submission to the registry

July 3, 2009

Completed
13 days until next milestone

First Posted

Study publicly available on registry

July 16, 2009

Completed
Last Updated

December 2, 2016

Status Verified

September 1, 2016

Enrollment Period

3 months

First QC Date

July 3, 2009

Last Update Submit

December 1, 2016

Conditions

Healthy

Keywords

Drug interactionsPharmacodynamic interactionsPharmacokinetic interactionsFormoterolHealthy subjectsPhase I studyRoflumilast

Outcome Measures

Primary Outcomes (1)

  • Potential cardiovascular interaction (exploratory)

Secondary Outcomes (2)

  • Potential pharmacokinetic interactions and potential pharmacodynamic interactions

  • Safety and tolerability of the monotreatments and the combination treatment (exploratory)

Study Arms (2)

Treatment A

ACTIVE COMPARATOR
Drug: Roflumilast

Treatment B

ACTIVE COMPARATOR
Drug: Roflumilast

Interventions

RoflumilastDRUG

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

Treatment A

Eligibility Criteria

Age18 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nycomed

Konstanz, 78467, Germany

Location

Related Publications (1)

  • 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.

    PMID: 21631929DERIVED

Related Links

MeSH Terms

Interventions

Roflumilast

Study Officials

  • AstraZeneca AstraZeneca

    AstraZeneca

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 3, 2009

First Posted

July 16, 2009

Study Start

April 1, 2004

Primary Completion

July 1, 2004

Study Completion

December 1, 2004

Last Updated

December 2, 2016

Record last verified: 2016-09

Locations

DE(1)