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A Study to Measure Serum Periostin, Asthma-Related Biomarkers and Response to Prednisolone in Adult and Adolescent Patients With Severe Oral Corticosteroid-Dependent Asthma

NCT01948401 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2016-11-02

No results posted yet for this study

Summary

This interventional, open study will evaluate clinical data in relation to biomarkers in patients 12 to 75 years of age with severe oral corticosteroid (OCS) - dependent asthma. Patients with uncontrolled asthma will be offered an additional escalation of OCS at a dose of 0.5 mg/kg for 7 days. Patients enrolled in this study would be eligible to be enrolled in a future placebo-controlled intervention study designed to measure the steroid-sparing effect of lebrikizumab.

Conditions

Interventions

DRUG

LABA

long-acting beta-agonist treatment

DRUG

corticosteroids

chronic treatment with oral corticosteroids, high dose inhaled corticosteroids

DRUG

prednisolone

additional 0.5 mg/kg orally for 7 days

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
NA
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
12 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-07-31
Primary Completion
2014-04-30
Completion
2014-04-30

Countries

  • United Kingdom

Study Locations

More Related Trials

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 NCT01948401 on ClinicalTrials.gov