Back to resultsSymbicort Onset of Action 1
Primary Purpose
Asthma
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
budesonide/formoterol (Symbicort)
fluticasone/salmeterol (Advair Diskus)
albuterol (Ventolin)
Sponsored by
About this trial
This is an interventional treatment trial for Asthma focused on measuring asthma, bronchodilatation, Symbicort, budesonide/formoterol, Advair Diskus, Ventolin
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of asthma and baseline lung function test results as determined by protocol
- Required and received asthma maintenance therapy within previous 4 weeks at doses determined by protocol
Exclusion Criteria:
- Severe asthma or asthma markedly affected by seasonal factors
- Has required treatment with any non-inhaled corticosteroids within previous 4 weeks, has sensitivity to drugs specified in the protocol or requires treatment with beta-blockers
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Active Comparator
Arm Label
1
2
3
Arm Description
budesonide/formoterol
fluticasone/salmeterol
albuterol
Outcomes
Primary Outcome Measures
FEV1 3 minutes post dose
Secondary Outcome Measures
12 hour serial FEV1
Patients perception of effect
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00646620
Brief Title
Symbicort Onset of Action 1
Official Title
A Randomized, Multicenter, Placebo and Active-Controlled, Single-Dose, 4-Period, Crossover Study to Evaluate the Bronchodilating Effect of SYMBICORT pMDI Versus Advair Diskus and Ventolin HFA.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2009
Overall Recruitment Status
Completed
Study Start Date
April 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2003 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
AstraZeneca
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to compare the early onset of effect of Symbicort compared to Advair Diskus and Ventolin in adults with asthma
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
asthma, bronchodilatation, Symbicort, budesonide/formoterol, Advair Diskus, Ventolin
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
48 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
budesonide/formoterol
Arm Title
2
Arm Type
Active Comparator
Arm Description
fluticasone/salmeterol
Arm Title
3
Arm Type
Active Comparator
Arm Description
albuterol
Intervention Type
Drug
Intervention Name(s)
budesonide/formoterol (Symbicort)
Other Intervention Name(s)
Symbicort
Intervention Type
Drug
Intervention Name(s)
fluticasone/salmeterol (Advair Diskus)
Other Intervention Name(s)
Advair Diskus
Intervention Type
Drug
Intervention Name(s)
albuterol (Ventolin)
Other Intervention Name(s)
Ventolin
Primary Outcome Measure Information:
Title
FEV1 3 minutes post dose
Time Frame
4 assessments across 4 visits whilst on treatment (visits may be between 3 and 14 days apart)
Secondary Outcome Measure Information:
Title
12 hour serial FEV1
Time Frame
4 assessments across 4 visits whilst on treatment (visits may be between 3 and 14 days apart)
Title
Patients perception of effect
Time Frame
4 assessments across 4 visits whilst on treatment (visits may be between 3 and 14 days apart)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of asthma and baseline lung function test results as determined by protocol
Required and received asthma maintenance therapy within previous 4 weeks at doses determined by protocol
Exclusion Criteria:
Severe asthma or asthma markedly affected by seasonal factors
Has required treatment with any non-inhaled corticosteroids within previous 4 weeks, has sensitivity to drugs specified in the protocol or requires treatment with beta-blockers
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Catherine Bonuccelli
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
12. IPD Sharing Statement
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Symbicort Onset of Action 1
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