A Comparison of Symbicort® pMDI 2 x 160/4.5 μg Bid and 2 x 80/4.5 μg Bid With Formoterol Turbuhaler® 2 x 4.5 μg Bid and Placebo in Patients With COPD
This study has been completed.
Sponsor:
AstraZeneca
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00206167
First received: September 13, 2005
Last updated: March 26, 2009
Last verified: March 2009
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Purpose
The purpose of this study is to compare Symbicort in a pressurized metered-dose inhaler (pMDI) with formoterol and placebo in the long-term maintenance treatment of patients with chronic obstructive pulmonary disease (COPD).
| Condition | Intervention | Phase |
|---|---|---|
|
Chronic Obstructive Pulmonary Disease |
Drug: Budesonide/formoterol pMDI Drug: Formoterol 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 12-Month Double-Blind, Double-Dummy, Randomized, Parallel Group, Multicenter Efficacy and Safety Study of Symbicort® pMDI 2 x 160/4.5 μg Bid and 2 x 80/4.5 μg Bid Compared to Formoterol Turbuhaler® 2 x 4.5 μg Bid and Placebo in Patients With COPD |
Resource links provided by NLM:
MedlinePlus related topics:
COPD (Chronic Obstructive Pulmonary Disease)
Drug Information available for:
Guaifenesin
Phenylpropanolamine hydrochloride
Triaminic
Phenylpropanolamine
Formoterol fumarate
Budesonide
Formoterol
Arformoterol Tartrate
U.S. FDA Resources
Further study details as provided by AstraZeneca:
Primary Outcome Measures:
- Pre-dose and 1-hour post-dose FEV1 over the 12 months treatment period
Secondary Outcome Measures:
- Patient-reported outcome variables regarding disease status (incl. PEF), collected via questionnaires and diaries
- Health care utilization
- Safety variables, including adverse events, vital signs, ECG, physical examination, hematology, and clinical chemistry.
- all variables assessed over the 12 months treatment period
| Estimated Enrollment: | 1600 |
| Study Start Date: | April 2005 |
| Study Completion Date: | September 2007 |
Eligibility| Ages Eligible for Study: | 40 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- A clinical diagnosis of COPD with symptoms for more than 2 years.
- Smoking history of 10 or more pack years
- A history of at least one COPD exacerbation requiring a course of oral steroids and/or antibiotics within 1-12 months before first visit.
Exclusion Criteria:
- A history of asthma
- Patients taking oral steroids
- 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: NCT00206167
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Sponsors and Collaborators
AstraZeneca
Investigators
| Study Director: | AstraZeneca Symbicort Medical Science Director, MD | AstraZeneca |
More Information
No publications provided by AstraZeneca
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov Identifier: | NCT00206167 History of Changes |
| Other Study ID Numbers: | D5899C00001, EurodraCT No: 2004-001 168-28, SUN |
| Study First Received: | September 13, 2005 |
| Last Updated: | March 26, 2009 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Lung Diseases Respiration Disorders Pulmonary Disease, Chronic Obstructive Lung Diseases, Obstructive Respiratory Tract Diseases 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 Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Anti-Inflammatory 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 June 18, 2013