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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00419744
First received: January 5, 2007
Last updated: August 18, 2010
Last verified: August 2010
  Purpose

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.


Condition Intervention Phase
Chronic Obstructive Pulmonary Disease
Drug: Budesonide/formoterol (SYMBICORT) 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 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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Total Number of Chronic Obstructive Pulmonary Disease (COPD) Exacerbations Per Patient-treatment Year [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Rate of exacerbations per subject-year


Secondary Outcome Measures:
  • Pre-dose Forced Expiratory Volume in 1 Second (FEV1) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Enrollment: 1200
Study Start Date: January 2007
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00419744

  Show 140 Study Locations
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Christer Hultquist, 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: NCT00419744     History of Changes
Other Study ID Numbers: D589CC00003
Study First Received: January 5, 2007
Results First Received: August 18, 2010
Last Updated: August 18, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by AstraZeneca:
COPD

Additional relevant MeSH terms:
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Lung Diseases
Respiratory Tract Diseases
Formoterol
Symbicort
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
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 September 22, 2014