A Clinical Study to Evaluate Symbicort Turbuhaler Used 'as Needed' in Adults and Adolescents With Asthma (SYGMA2)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02224157|
Recruitment Status : Completed
First Posted : August 25, 2014
Last Update Posted : December 7, 2017
|Condition or disease||Intervention/treatment||Phase|
|Asthma||Drug: budesonide/formoterol 'as needed' + budesonide placebo bid Drug: budesonode bid + terbutaline 'as needed'||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||4215 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|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
Symbicort (budesonide/formoterol) Turbuhaler 160/4.5 μg 'as needed' + Placebo Pulmicort Turbuhaler 200 μg bid
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
Active Comparator: Pulmicort bid + terbutaline 'as needed'
Pulmicort 200 μg Turbuhaler bid + terbutaline 0.4 mg Turbuhaler 'as needed'
Drug: budesonode 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
- Annual severe asthma exacerbation rate [ Time Frame: up to 52 weeks ]
- Time to first severe asthma exacerbation [ Time Frame: up to 52 weeks ]
- Average change from baseline in pre-dose FEV1 [ Time Frame: study weeks 0,17, 34, 52 ]
- Time to study specific asthma related discontinuation [ Time Frame: up to 52 weeks ]Study scpecific discontinuation of IP criteria: - A severe asthma exacerbation with a duration for more than 3 weeks - Three severe asthma exacerbations during 6 months
- Average change from baseline in 'as needed' use [ Time Frame: up to 52 weeks ]
'As-needed'-use will be calculated as the cumulative doses of 'as-needed' medication divided by the follow-up time (number of days).
For Symbicort treatment arm 'as needed' will be Symbicort, while for the Pulmicort treatment arm 'as needed' will be terbutaline.
Change from baseline will be calculated for each patient, where baseline is defined as the 'as needed' use 10 days prior to randomisation during run-in.
- Change from baseline in percent of 'as needed' free days [ Time Frame: up to 52 weeks ]
- Percentage of controller use days [ Time Frame: up to 52 weeks ]
- Average change from baseline in Asthma Control Questionnaire (5-item version) - ACQ-5 score [ Time Frame: study weeks 0, 17, 34, 52 ]
- Average change from baseline in Asthma Quality of Life Questionnaire Standardised Version - AQLQ(S) score [ Time Frame: study weeks 0,17, 34, 52 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02224157
Show 343 Study Locations
|Study Director:||Carin Jorup, MD||AstraZeneca Research & Development|