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A Comparison of SYMBICORT® pMDI With Formoterol Turbuhaler® in Subjects With COPD

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00419744
Recruitment Status : Completed
First Posted : January 9, 2007
Results First Posted : September 16, 2010
Last Update Posted : September 16, 2010
Sponsor:
Information provided by:
AstraZeneca

Tracking Information
First Submitted Date  ICMJE January 5, 2007
First Posted Date  ICMJE January 9, 2007
Results First Submitted Date  ICMJE August 18, 2010
Results First Posted Date  ICMJE September 16, 2010
Last Update Posted Date September 16, 2010
Study Start Date  ICMJE January 2007
Actual Primary Completion Date August 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 18, 2010)
  • Total Number of Chronic Obstructive Pulmonary Disease (COPD) Exacerbations Per Patient-treatment Year [ Time Frame: 12 months ]
    Number of COPD-related exacerbations per patient-treatment year. COPD-related exacerbation was defined as worsening COPD that required a course of oral steriods for treatment and/or hospitalization.
  • Rate of Exacerbations Per Subject-year [ Time Frame: 12 months ]
    Rate of exacerbations per subject-year
Original Primary Outcome Measures  ICMJE
 (submitted: January 5, 2007)
The primary objective of this study is to compare efficacy for preventing exacerbations of SYMBICORT pMDI 160/4.5 μg x 2 actuations bid and 80/4.5 μg x 2 actuations bid compared to formoterol Turbuhaler® 4.5 μg x 2 inhalations bid in COPD subjects.
Change History Complete list of historical versions of study NCT00419744 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 18, 2010)
  • Pre-dose Forced Expiratory Volume in 1 Second (FEV1) [ Time Frame: 12 months ]
    Change in pre-dose FEV1 from baseline to the average of the randomized treatment period, as calculated by averaging treatment period FEV1 values and subtracting the pre-dose value.
  • Morning Peak Expiratory Flow (PEF) [ Time Frame: 12 months ]
    Change in morning PEF from baseline to the average of the randomized treatment period, as calculated by averaging treatment period PEF values and subtracting the baseline morning PEF value.
  • Evening PEF [ Time Frame: 12 months ]
    Change in evening PEF from baseline to the average of the randomized treatment period, as calculated by averaging treatment period PEF values and subtracting the baseline evening PEF value.
  • Dyspnea Symptom Scores [ Time Frame: 12 months ]
    Change from baseline of Dyspnea symptoms evaluated using the breathlessness diary, a 5-point Likert-type scale, ranging from 0 to 4 with higher scores indicating a more severe manifestation of the Dyspnea symptom. Change from baseline was calculated by averaging treatment period Dyspnea scores and subtracting the baseline Dyspnea scores.
  • Use of Rescue Medication [ Time Frame: 12 months ]
    Change from baseline in the use of beta-2 agonists, as calculated by averaging treatment period inhalations per day and subtracting the baseline number of inhalations per day.
  • St. George's Respiratory Questionnaire (SGRQ) Score [ Time Frame: 12 months ]
    Change from baseline in the SGRQ overall score, as calculated by averaging treatment period SGRQ scores and subtracting the baseline SGRQ scores. The SGRQ contains 3 domains: Symptoms (distress due to respiratory symptoms, 8 questions), Activity (disturbance of physical activity, 16 questions), and Impacts (overall impact on daily life and well-being, 26 questions). Lower scores are associated with less severe symptoms.
Original Secondary Outcome Measures  ICMJE
 (submitted: January 5, 2007)
The secondary objective of this study is to demonstrate the safety of both SYMBICORT® pMDI doses compared to that of formoterol Turbuhaler® in subjects with COPD.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Comparison of SYMBICORT® pMDI With Formoterol Turbuhaler® in Subjects With COPD
Official Title  ICMJE A Phase IIIB, 12-Month, Double-blind, Double-dummy,Randomised, Parallel-group, Multicentre Exacerbation Study of SYMBICORT® pMDI 160/4.5 μg x 2 Actuations Twice-daily and 80/4.5 μg x 2 Actuations Twice-daily Compared to Formoterol Turbuhaler® 4.5 μg x 2 Inhalations Twice-daily in COPD Subjects
Brief Summary The purpose of this study is to determine if SYMBICORT® delivered via a pressurized metered-dose inhaler, referred to as a pMDI, is effective in preventing COPD exacerbations.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Chronic Obstructive Pulmonary Disease
Intervention  ICMJE
  • Drug: Budesonide/formoterol (SYMBICORT) pMDI
  • Drug: Formoterol Turbuhaler
Study Arms  ICMJE Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 5, 2007)
1200
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2009
Actual Primary Completion Date August 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • A current clinical diagnosis of COPD with COPD symptoms for more than 2 years
  • Current smoker or smoking history of 10 or more pack years (1 pack year = 20 cigarettes smoked per day for one year)
  • A history of at least 1 COPD exacerbations requiring a course of steroids and/or antibiotics within 1-12 months before the first visit

Exclusion Criteria:

  • A history of asthma at or after 18 years of age
  • A history of allergic rhinitis at or after 18 years of age
  • Subjects taking oral steroids
  • Any significant disease or disorder that may jeopardize a subject's safety
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Brazil,   Chile,   Colombia,   Mexico,   Peru,   South Africa,   United States,   Venezuela
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00419744
Other Study ID Numbers  ICMJE D589CC00003
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE AstraZeneca
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Christer Hultquist, MD AstraZeneca
PRS Account AstraZeneca
Verification Date August 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP