- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00651768
Titratable Dosing in Moderate to Severe Asthmatics
January 21, 2011 updated by: AstraZeneca
A 52 wk Randomized, Doubleblind, Single Dummy, Parallel Group Multicenter Phase 3 Study Comparing the Long Term Safety of Symbicort pMDI 4x160/4.5mcg Bid to SymbicortpMDI 2x160/4.5mcg Bid & Budesonide HFA pMDI 4x160mcg Bid in Adult and Adolescent Subjects With Asthma
The purpose of this study is to compare the long term safety of Symbicort with budesonide alone, in adolescents and adults with asthma.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
570
Phase
- Phase 3
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
12 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Diagnosis of asthma and baseline lung function tests, symptoms and medication use as determined by the protocol
- Required and received treatment with inhaled corticosteroids within the timeframe and doses specified in the protocol
Exclusion Criteria:
- Has required treatment with non-inhaled corticosteroids within previous 30 days, has sensitivity to drugs specified in the protocol or requires treatment with a beta-blocker.
- Has had cancer within previous 5 years or has a condition that may put the patient at risk in this study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
|
Other Names:
|
Sham Comparator: 2
|
Symbicort 2 X 160/4.5mcg
& budesonide HFA pMDI 4 X 160mcg
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Asthma exacerbations, ECG and Holter monitors, lung function, adverse events, requirement of other asthma therapies and other routine safety assessments.
Time Frame: 7 assessments within 12 month treatment period
|
7 assessments within 12 month treatment period
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To measure changes in lung function tests, patient reported outcomes and usage of medical resource
Time Frame: 7 assessments within 12 month treatment period
|
7 assessments within 12 month treatment period
|
Blood levels of budesonide and formoterol
Time Frame: 10 blood samples taken at 1 visit in a sub-set of patients
|
10 blood samples taken at 1 visit in a sub-set of patients
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Catherine Bonuccelli, AstraZeneca
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2003
Study Completion (Actual)
January 1, 2005
Study Registration Dates
First Submitted
April 1, 2008
First Submitted That Met QC Criteria
April 2, 2008
First Posted (Estimate)
April 3, 2008
Study Record Updates
Last Update Posted (Estimate)
January 24, 2011
Last Update Submitted That Met QC Criteria
January 21, 2011
Last Verified
January 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Immune System Diseases
- Lung Diseases
- Hypersensitivity, Immediate
- Bronchial Diseases
- Lung Diseases, Obstructive
- Respiratory Hypersensitivity
- Hypersensitivity
- Asthma
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Anti-Inflammatory Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Adrenergic Agonists
- Bronchodilator Agents
- Anti-Asthmatic Agents
- Respiratory System Agents
- Adrenergic beta-2 Receptor Agonists
- Adrenergic beta-Agonists
- Budesonide
- Formoterol Fumarate
- Budesonide, Formoterol Fumarate Drug Combination
Other Study ID Numbers
- SD-039-0728
- D5896C00728
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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