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Clinical trial

A Clinical Study to Evaluate Symbicort Turbuhaler Used 'as Needed' in Adults and Adolescents With Asthma (SYGMA2)

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Last updated:28th Nov 2014
Identifier: NCT02224157

Brief 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 Pulmicort (budesonide) Turbuhaler twice daily plus terbutaline Turbuhaler 'as needed'

Detailed Description:
A 52-week, double-blind, randomised, multi-centre, phase III, parallel-group study in patients 12 years and older with asthma, evaluating the efficacy and safety of Symbicort (budesonide/formoterol) Turbuhaler 160/4.5 μg 'as needed' compared with Pulmicort (budesonide) Turbuhaler 200 μg twice daily plus terbutaline Turbuhaler 0.4 mg 'as needed'

Study Type: Interventional  (Clinical Trial)
Actual Enrollment: 4215 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Clinical Study Comparing Symbicort 'as Needed' With Pulmicort Twice Daily Plus Terbutaline 'as Needed' in Adult and Adolescent Patients With Asthma
Actual Study Start Date: November 28, 2014
Actual Primary Completion Date: August 16, 2017
Actual Study Completion Date: August 16, 2017

- Experimental:
Symbicort 'as needed'+placebo Pulmicort bid
- Active Comparator: Pulmicort bid + terbutaline 'as needed'

Related journal:
- As-Needed Budesonide-Formoterol versus Maintenance Budesonide in Mild Asthma.

Category Value
Date last updated at source 2017-12-07
Study type(s) Interventional
Expected enrolment 4215
Study start date 2014-11-28
Estimated primary completion date 2017-08-16

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