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A 6 Month Safety Study Comparing Symbicort With Inhaled Corticosteroid Only in Asthmatic Adults and Adolescents

NCT01444430 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 12460

Last updated 2016-12-15

Study results available
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Summary

The purpose of the study is to evaluate the safety of Symbicort compared to inhaled corticosteroid alone during 6 months in adult and adolescent patients with asthma

Conditions

Interventions

DRUG

Symbicort pMDI

Patients were randomized to Symbicort and assigned to one of the following treatments (based upon ACQ at baseline and prior asthma therapy): Symbicort pMDI 80/4.5 μg x 2 actuations bid (morning and evening) or Symbicort pMDI 160/4.5 μg x 2 actuations bid (morning and evening), for oral inhalation.

DRUG

budesonide pMDI

Patients were randomized to budesonide and assigned to one of the following treatments (based upon ACQ at baseline and prior asthma therapy): budesonide pMDI 80 μg x 2 actuations bid (morning and evening) or budesonide pMDI 160 μg x 2 actuations bid (morning and evening), for oral inhalation.

Sponsors & Collaborators

Principal Investigators

  • Carin Jorup · AstraZeneca Pepparedsleden 1, 431 83 Mölndal

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2011-12-31
Primary Completion
2015-10-31
Completion
2015-10-31

Countries

  • United States
  • Argentina
  • Brazil
  • Bulgaria
  • Chile
  • Colombia
  • Czechia
  • France
  • Germany
  • India
  • Italy
  • Mexico
  • Panama
  • Peru
  • Philippines
  • Poland
  • Puerto Rico
  • Romania
  • Russia
  • Slovakia
  • South Africa
  • South Korea
  • Thailand
  • Ukraine
  • United Kingdom
  • Vietnam

Study Locations

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Entities

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 NCT01444430 on ClinicalTrials.gov