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To Assess the Pharmacokinetics, Safety and Tolerability of Abediterol Administered Once Daily for 9 Days, in Patients With Asthma on Inhaled Corticosteroids

NCT03273127 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2017-11-27

No results posted yet for this study

Summary

A Phase 1 study to assess pharmacokinetics (PK) and safety of abediterol 5 μg dry powder inhaler (DPI) given once daily (QD) for 9 days, compared to placebo, in patients with asthma on inhaled corticosteroids (ICSs).

Conditions

Interventions

DRUG

Abediterol

A β2-adrenoceptor agonists, produce smooth muscle relaxation in the airways and improves lung function.

DRUG

Placebo

Abediterol matching placebo without any pharmacological activity.

Sponsors & Collaborators

Principal Investigators

  • Dr.med. Rainard Fuhr · PAREXEL Early Phase Clinical Unit Berlin

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-21
Primary Completion
2017-11-09
Completion
2017-11-09

Countries

  • Germany

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03273127 on ClinicalTrials.gov