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A Clinical Study to Evaluate Symbicort Turbuhaler Used 'as Needed' in Adults and Adolescents With Asthma.

NCT02149199 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 3850

Last updated 2019-11-15

Study results available
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Summary

The purpose of this study is to test if Symbicort® (budesonide/formoterol) Turbuhaler® is effective in treating asthma when used 'as needed' in patients with milder asthma. The efficacy of Symbicort® 'as needed' will be compared with: 1) terbutaline Turbuhaler® 'as needed' and with 2) Pulmicort (budesonide) Turbuhaler® twice daily plus terbutaline Turbuhaler® 'as needed'.

Conditions

Interventions

DRUG

budesonide/formoterol 'as needed' + budesonide placebo bid

Symbicort (budesonide/ formoterol) 160/4.5 μg powder for inhalation 'as needed' plus Pulmicort placebo 200 μg powder for inhalation, 1 inhalation twice daily (morning and evening), 52-week treatment

DRUG

terbutaline 'as needed' + placebo budesonide bid

Terbutaline 0.4 mg powder for inhalation 'as needed' plus placebo Pulmicort (budesonide) 200 μg powder for inhalation, 1 inhalation twice daily (morning and evening), 52-week treatment

DRUG

budesonide bid + terbutaline 'as needed'

Pulmicort (budesonide) 200 μg powder for inhalation, 1 inhalation twice daily (morning and evening) plus terbutaline 0.4 mg powder for inhalation 'as needed', 52-week treatment

Sponsors & Collaborators

Principal Investigators

  • Paul M O'Byrne, MB, FRCP(C), FRSC · McMaster University, Hamilton, Canada

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2014-07-07
Primary Completion
2017-08-02
Completion
2017-08-02

Countries

  • Australia
  • Brazil
  • Bulgaria
  • Canada
  • Chile
  • China
  • Hungary
  • Mexico
  • Peru
  • Philippines
  • Poland
  • Romania
  • Russia
  • South Africa
  • South Korea
  • Ukraine
  • United Kingdom
  • Vietnam

Study Locations

More Related Trials

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 NCT02149199 on ClinicalTrials.gov