A Comparison of the Control of Asthma Provided by Symbicort® Turbuhaler® Versus Symbicort® Turbuhaler® Plus Pulmicort® Turbuhaler® Plus Terbutaline Turbuhaler®
This study has been completed.
Sponsor:
AstraZeneca
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00244608
First received: October 25, 2005
Last updated: January 21, 2011
Last verified: January 2011
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Purpose
The purpose of this study is to determine if a flexible dose of Symbicort has a similar effect on the airways of patients with asthma as a higher fixed-dose of Symbicort with additional glucocorticosteroids added.
| Condition | Intervention | Phase |
|---|---|---|
|
Asthma |
Drug: Budesonide/Formoterol Turbuhaler Drug: Budesonide Turbuhaler (Pulmicort) Drug: Terbutaline Turbuhaler |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | A Comparison of the Inflammatory Control of Asthma Provided by One Inhalation of Symbicort® Turbuhaler® 160/4.5 µg/Inhalation b.i.d. Plus As-needed Versus One Inhalation of Symbicort® Turbuhaler® 320/9 µg/Inhalation b.i.d. + One Inhalation of Pulmicort® Turbuhaler® 400 µg/Dose b.i.d. Plus Terbutaline Turbuhaler® 0.4 mg/Inhalation As-needed. A 12-month, Randomised, Double-blind, Parallel-group, Active Controlled, Multinational, Phase IIIB Study in Adult Patients With Asthma, EOS |
Resource links provided by NLM:
MedlinePlus related topics:
Asthma
Drug Information available for:
Terbutaline
Terbutaline sulfate
Formoterol fumarate
Budesonide
Formoterol
Arformoterol Tartrate
U.S. FDA Resources
Further study details as provided by AstraZeneca:
Primary Outcome Measures:
- Change in eosinophils in bronchial biopsies (first and last visit) and in sputum (5 times during the 12-month treatment period)
Secondary Outcome Measures:
- Immunopathology and remodeling in biopsies
- Immunopathology and mediators in induced sputum
- Severe asthma exacerbations (number of and time to first)
- Forced expiratory volume in 1 second (FEV1)
- As-needed use
- Safety variables, including adverse events and vital signs
- All variables assessed over the 12-month treatment period
| Estimated Enrollment: | 100 |
| Study Start Date: | May 2005 |
| Study Completion Date: | March 2007 |
Intervention Details:
-
Drug: Budesonide/Formoterol Turbuhaler
Other Name: Symbicort
Drug: Budesonide Turbuhaler (Pulmicort)
Drug: Terbutaline Turbuhaler
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Diagnosis of asthma for at least 6 months
- Prescribed daily use of glucocorticosteroids for at least 3 months prior to visit one
Exclusion Criteria:
- Respiratory infection affecting asthma within 30 days prior to study
- Intake of oral, rectal, or parenteral glucocorticosteroids within 30 days prior to study
- Any significant disease or disorder that may jeopardize the safety of the patient
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00244608
Locations
| Denmark | |
| Research Site | |
| Copenhagen, Denmark | |
| Research Site | |
| Ålborg, Denmark | |
| Research Site | |
| Århus C, Denmark | |
| France | |
| Research Site | |
| Montpellier, France | |
| Research Site | |
| Pessac, France | |
| Germany | |
| Research Site | |
| Hannover, Germany | |
| Research Site | |
| Mainz, Germany | |
| Research Site | |
| Marburg, Germany | |
| Spain | |
| Research Site | |
| Baraclado, Spain | |
| Research Site | |
| Barcelona No. 40, Spain | |
| Research Site | |
| Barcelona, No. 42, Spain | |
| Sweden | |
| Research Site | |
| Göteborg, Sweden | |
| Research Site | |
| Lund, Sweden | |
| Research Site | |
| Stockholm, Sweden | |
| Research Site | |
| Umeå, Sweden | |
| Research Site | |
| Uppsala, Sweden | |
| United Kingdom | |
| Research Site | |
| Glasgow, United Kingdom | |
| Research Site | |
| Leicester, United Kingdom | |
| Research Site | |
| London, United Kingdom | |
| Research Site | |
| Manchester, United Kingdom | |
| Research Site | |
| Newcastle-Upon-Tyne, United Kingdom | |
| Research Site | |
| Southampton, United Kingdom | |
Sponsors and Collaborators
AstraZeneca
Investigators
| Study Director: | AstraZeneca Symbicort Medical Science Director, MD | AstraZeneca |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00244608 History of Changes |
| Other Study ID Numbers: | D5890C00003, EudraCT no. 2004-004042-41 |
| Study First Received: | October 25, 2005 |
| Last Updated: | January 21, 2011 |
| Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Additional relevant MeSH terms:
|
Asthma Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Terbutaline Budesonide Formoterol Symbicort Bronchodilator Agents Autonomic Agents |
Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Anti-Asthmatic Agents Respiratory System Agents Therapeutic Uses Sympathomimetics Tocolytic Agents Reproductive Control Agents Adrenergic beta-2 Receptor Agonists Adrenergic beta-Agonists Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 19, 2013