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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00242775
Registration number
NCT00242775
Ethics application status
Date submitted
20/10/2005
Date registered
21/10/2005
Date last updated
24/01/2011
Titles & IDs
Public title
Comparison of the Efficacy/Safety of Symbicort® Turbuhaler®,Seretide™ Diskus™ 50/500 µg & Terbutaline Turbuhaler® 0.4 mg
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Scientific title
Efficacy and Safety of Symbicort ®Turbuhaler® 160/4.5 µg/Inhalation, Two Inhalations Twice Daily Plus As-needed Compared With Seretide™ Diskus™ 50/500 µg/Inhalation, One Inhalation Twice Daily Plus Terbutaline Turbuhaler 0.4 mg/Inhalation As-needed - a 6-month, Randomised, Double-blind, Parallel-group, Active Controlled, Multinational Phase IIIB Study in Adult and Adolescent Patients With Persistent Asthma (AHEAD).
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Secondary ID [1]
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EurodraCT No. 2004-004905-11
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Secondary ID [2]
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D5890C00002
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Asthma
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0
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Condition category
Condition code
Respiratory
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0
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Asthma
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Time to first severe asthma exacerbation
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Assessment method [1]
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Timepoint [1]
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Secondary outcome [1]
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Number of severe asthma exacerbations
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Assessment method [1]
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Timepoint [1]
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Secondary outcome [2]
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Mild asthma exacerbations
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Assessment method [2]
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Timepoint [2]
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Secondary outcome [3]
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FEV1
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Assessment method [3]
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Timepoint [3]
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Secondary outcome [4]
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Patient-reported outcomes regarding disease status (inlc. PEF), collected via questionnaires and diaries
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Assessment method [4]
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Timepoint [4]
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Secondary outcome [5]
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Healthcare utilization
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Timepoint [5]
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Secondary outcome [6]
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Safety (adverse events)
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Assessment method [6]
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Timepoint [6]
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Secondary outcome [7]
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- all variables assessed over the 6 months treatment period
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Assessment method [7]
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Timepoint [7]
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Eligibility
Key inclusion criteria
* Diagnosed with asthma since at least 6 months prior to first visit
* Prescribed daily use of glucocorticosteroids for at least 3 months prior to first visit
* At least one asthma exacerbation more than one but less than twelve months prior to first visit
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Minimum age
12
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Respiratory infection affecting asthma within 30 days before first visit
* Use of oral, rectal, or parenteral glucocorticosteroids for within 30 days before first visit
* Any significant disease or disorder that may jeopardize the safety of the patient
Additional inclusion and exclusion criteria will be evaluated by the Investigator.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/05/2005
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/05/2006
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Sample size
Target
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Final
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Recruitment in Australia
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NSW,QLD,SA,VIC,WA
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
AstraZeneca
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Address
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Ethics approval
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Summary
Brief summary
The purpose of this study is to compare the efficacy and safety of a variable dose of Symbicort with a high fixed maintenance dose of another asthma medication, Seretide, in the treatment of asthma.
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Trial website
https://clinicaltrials.gov/study/NCT00242775
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Trial related presentations / publications
Lin JT, Chen P, Zhou X, Sun TY, Xie CM, Xiu QY, Yao WZ, Yang L, Yin KS, Zhang YM. Budesonide/formoterol maintenance and reliever therapy in Chinese patients with asthma. Chin Med J (Engl). 2012 Sep;125(17):2994-3001. Bousquet J, Boulet LP, Peters MJ, Magnussen H, Quiralte J, Martinez-Aguilar NE, Carlsheimer A. Budesonide/formoterol for maintenance and relief in uncontrolled asthma vs. high-dose salmeterol/fluticasone. Respir Med. 2007 Dec;101(12):2437-46. doi: 10.1016/j.rmed.2007.07.014. Epub 2007 Oct 1. Erratum In: Respir Med. 2008 Jun;102(6):937-8.
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Public notes
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Contacts
Principal investigator
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AstraZeneca Symbicort Medical Science Director, MD
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AstraZeneca
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT00242775
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