A clinical study to evaluate Symbicort Turbuhaler used ’as needed’ in adults and adolescents with asthma. - SYGMA1

Study identifier:D589SC00001

ClinicalTrials.gov identifier:NCT02149199

EudraCT identifier:2013-004474-96

CTIS identifier:N/A

Study Complete

Official Title

A clinical study comparing Symbicort® ‘as needed’ with terbutaline ‘as needed’ and with Pulmicort® twice daily plus terbutaline ‘as needed’ in adult and adolescent patients with asthma.

Medical condition

asthma

Phase

Phase 3

Healthy volunteers

No

Study drug

budesonide/formoterol 'as needed' + budesonide placebo bid, terbutaline 'as needed' + placebo budesonide bid, budesonide bid + terbutaline 'as needed'

Sex

All

Actual Enrollment

3850

Study type

Interventional

Age

12 Years - 130 Years

Date

Study Start Date: 07 Jul 2014
Primary Completion Date: 02 Aug 2017
Study Completion Date: 02 Aug 2017

Study design

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment

Verification:

Verified 01 Nov 2019 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

-

Inclusion and exclusion criteria