A Rand, Doubleblind, Activecontrolled, Parallel-grp,Singledummy, Multicenter,12 wk Study to Assess the Effic.&Safety of Symbicort pMDI 2x160/4.5mcg QD Compared to Symb. pMDI 2x80/4.5mcg QD, Symb. pMDI 2x80/4.5mcg Bid and to Budesonide pMDI 2x160 Mcg QD in Asthmatic Sub's12yrs and Over
Sponsor study identifier
interventional
615
0 countries
N/A
Study Start
October 2003
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
Not reported
Date not reportedStudy Completion
February 2005
Actual (reported)The purpose of this study is to determine whether treatment with Symbicort for 12 weeks will improve lung function and symptoms of adults and adolescents with asthma.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 2005
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 2003
Date type not reportedThis date has not been verified as actual or estimated.
February 2005
Actual (reported)March 26, 2008
Actual (reported)March 28, 2008
Actual (reported)Change from start of treatment in evening pre-dose FEV1
2, 6 and 12 weeks after starting treatment
Change from before treatment in lung function, symptoms, use of rescue medication and patient-physician reported outcomes
Daily
Investigate safety profile of Symbicort and budesonide
Before and 2, 4, 12 weeks after start of treatment and 1 week after end of treatment
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Grouped treatment entry
budesonide/formoterol (Symbicort)
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry recordKerwin EM, Oppenheimer JJ, LaForce C, Parasuraman B, Miller CJ, O'Dowd L, Goldman M. Efficacy and tolerability of once-daily budesonide/formoterol pressurized metered-dose inhaler in adults and adolescents with asthma previously stable with twice-daily budesonide/ formoterol dosing. Ann Allergy Asthma Immunol. 2009 Jul;103(1):62-72. doi: 10.1016/S1081-1206(10)60145-7.
Liza O'Dowd, MD
AstraZeneca
Catherine Bonuccelli
AstraZeneca
First Submitted
March 26, 2008
First Posted
March 28, 2008
Study Start
October 2003
Date type not reportedThis date has not been verified as actual or estimated.
Study Completion
February 2005
Actual (reported)Efficacy and Safety Study of Symbicort Turbuhaler in Chinese Patients With COPD
Contact the study team to confirm eligibility.
Last Updated
January 24, 2011
Record last verified: 2011-01
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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