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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00206167 |
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Date of registration:
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13/09/2005 |
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Primary sponsor: |
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Public title:
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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
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Scientific title:
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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 |
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Date of first enrolment:
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April 2005 |
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Target sample size:
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1600 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00206167 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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Countries of recruitment
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Bulgaria
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Denmark
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Germany
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Greece
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Hungary
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Iceland
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Mexico
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Romania
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United States
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Contacts
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Name:
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AstraZeneca Symbicort Medical Science Director, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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AstraZeneca |
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Key inclusion & exclusion criteria
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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
Age minimum:
40 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Chronic Obstructive Pulmonary Disease
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Intervention(s)
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Drug: Budesonide/formoterol pMDI
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Drug: Formoterol Turbuhaler
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Primary Outcome(s)
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Pre-dose and 1-hour post-dose FEV1 over the 12 months treatment period
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Secondary Outcome(s)
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all variables assessed over the 12 months treatment period
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Health care utilization
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Patient-reported outcome variables regarding disease status (incl. PEF), collected via questionnaires and diaries
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Safety variables, including adverse events, vital signs, ECG, physical examination, hematology, and clinical chemistry.
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Secondary ID(s)
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D5899C00001
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EurodraCT No: 2004-001 168-28
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SUN
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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