Evaluation of Onset of Effect in Patients With Severe Chronic Obstructive Pulmonary Disease (COPD) Treated With Symbicort® Compared to Seretide® (SPEED)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00542880
First received: October 10, 2007
Last updated: July 27, 2012
Last verified: July 2012
  Purpose

This study is to assess the effects with two different inhaled respiratory medications with regards to improvement of lung function, symptoms and morning activities.


Condition Intervention Phase
Chronic Obstructive Pulmonary Disease (COPD)
Drug: Symbicort Turbuhaler (budesonide/formoterol) 320/9 μg
Drug: Seretide Diskus (salmeterol/fluticasone) 50/500 μg
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Double-blind, Randomised, Cross-over, Multi-centre Study, to Evaluate Onset of Effect in the Morning in Patients With Severe Chronic Obstructive Pulmonary Disease (COPD) Treated With Symbicort®Turbuhaler® 320/9 μg, Compared With Seretide® Diskus® 50/500 μg, Both Given as One Inhalation Twice Daily for One Week Each.

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Peak Expiratory Flow (PEF) 5 Minutes After Morning Dose [ Time Frame: Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days ] [ Designated as safety issue: No ]
    The change from baseline in PEF was calculated using the average over baseline (the last 7 days of run-in and washout period respectively), and all days of treatment, with baseline as covariate.


Secondary Outcome Measures:
  • PEF Before Morning Dose [ Time Frame: Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days ] [ Designated as safety issue: No ]
    The change from baseline was calculated using the average over baseline (the last 7 days of run-in and washout period respectively), and over all days of treatment, with baseline as covariate.

  • PEF 15 Minutes After Morning Dose [ Time Frame: Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days ] [ Designated as safety issue: No ]
    The change from baseline was calculated using the average over baseline (the last 7 days of run-in and washout period respectively), and over all days of treatment, with baseline as covariate.

  • PEF Before Evening Dose [ Time Frame: Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days ] [ Designated as safety issue: No ]
    The change from baseline was calculated using the average over baseline (the last 7 days of run-in and washout period respectively), and over all days of treatment, with baseline as covariate.

  • Forced Expiratory Volume in 1 Second (FEV1) Before Morning Dose [ Time Frame: Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days ] [ Designated as safety issue: No ]
    The change from baseline was calculated using the average over baseline (the last 7 days of run-in and washout period respectively), and over all days of treatment, with baseline as covariate.

  • FEV1 15 Minutes After Morning Dose [ Time Frame: Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days ] [ Designated as safety issue: No ]
    The change from baseline was calculated using the average over baseline (the last 7 days of run-in and washout period respectively), and over all days of treatment, with baseline as covariate.

  • FEV1 Before Evening Dose [ Time Frame: Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days ] [ Designated as safety issue: No ]
    The change from baseline was calculated using the average over baseline (the last 7 days of run-in and washout period respectively), and over all days of treatment, with baseline as covariate.

  • Change in PEF From Before Dose to 5 Minutes After Dose in the Morning [ Time Frame: Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days ] [ Designated as safety issue: No ]
    The change from pre-dose was calculated using the average over baseline (the last 7 days of run-in and washout period respectively), and over all days of treatment, with pre-dose run-in/washout as covariate.

  • Change in PEF From Before Dose to 15 Minutes After Dose in the Morning [ Time Frame: Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days ] [ Designated as safety issue: No ]
    The change from pre-dose was calculated using the average over baseline (the last 7 days of run-in and washout period respectively), and over all days of treatment, with mean pre-dose run-in/washout as covariate.

  • Change in FEV1from Before Dose to 5 Minutes After Dose in the Morning [ Time Frame: Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days ] [ Designated as safety issue: No ]
    The change from pre-dose was calculated using the average over baseline (the last 7 days of run-in and washout period respectively), and over all days of treatment, with mean pre-dose run-in/washout as covariate.

  • Change in FEV1 From Before Dose to 15 Minutes After Dose in the Morning [ Time Frame: Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days ] [ Designated as safety issue: No ]
    The change from pre-dose was calculated using the average over baseline (the last 7 days of run-in and washout period respectively), and over all days of treatment, with mean pre-dose run-in/washout as covariate.

  • Change in FEV1 From Before Dose to 5 Minutes After Dose at the Clinic [ Time Frame: Baseline (run-in, and washout) and day 1 of treatment period ] [ Designated as safety issue: No ]
    The change from pre-dose was calculated using the pre-dose baseline value (run-in and washout period respectively), and pre-dose value at day 1, with pre-dose run-in/washout as covariate.

  • Change in Forced Vital Capacity (FVC) From Before Dose to5 Minutes After Dose at the Clinic [ Time Frame: Baseline (run-in, and washout) and day 1 of treatment period ] [ Designated as safety issue: No ]
    The change from pre-dose was calculated using the pre-dose baseline value (run-in and washout period respectively), and pre-dose value at day 1, with pre-dose run-in/washout as covariate.

  • Capacity of Daily Living in the Morning (CDLM) (Change From Pre to End of Treatment) [ Time Frame: Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days ] [ Designated as safety issue: Yes ]
    The change from baseline was calculated using the average over baseline (the last 7 days of run-in and washout period respectively), and over all days of treatment, with baseline as covariate. Score scale 0 - 5 with 0=worst and 5 = best.

  • Difficulty in Getting Out From Bed (MASQ) (Change From Pre to End of Treatment) [ Time Frame: Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days ] [ Designated as safety issue: No ]
    The change from baseline was calculated using the average over baseline (the last 7 days of run-in and washout period respectively), and over all days of treatment, with baseline as covariate. Score scale 0 - 5 with 0=worst and 5 = best.

  • The Clinical Chronic Obstructive Pulmonary Disease (COPD) Questionnaire (Change From Pre to End of Treatment) [ Time Frame: Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days ] [ Designated as safety issue: No ]
    The change from baseline was calculated using the average over baseline (the last 7 days of run-in and washout period respectively), and over all days of treatment, with baseline as covariate. Score scale 0 - 6 with 0=worst and 6 = best.


Enrollment: 442
Study Start Date: September 2007
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Symbicort Turbuhaler First, then Seretide Diskus
Symbicort Turbuhaler (budesonide/formoterol) 320/9 μg First, then Seretide Diskus (salmeterol/fluticasone) 50/500 μg
Drug: Symbicort Turbuhaler (budesonide/formoterol) 320/9 μg Drug: Seretide Diskus (salmeterol/fluticasone) 50/500 μg
Experimental: Seretide Diskus First, then Symbicort Turbuhaler
Seretide Diskus (salmeterol/fluticasone) 50/500 μg First, then Symbicort Turbuhaler (budesonide/formoterol) 320/9 μg
Drug: Symbicort Turbuhaler (budesonide/formoterol) 320/9 μg Drug: Seretide Diskus (salmeterol/fluticasone) 50/500 μg

  Eligibility

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

Inclusion Criteria:

  • Outpatient, female or male aged ≥40 years, diagnosis of COPD with symptoms for at least 2 years
  • FEV1 ≤50% of predicted normal value, pre-bronchodilator, FEV1/VC <70%
  • Pre-bronchodilator

Exclusion Criteria:

  • Current respiratory tract disorder other than COPD
  • History of asthma or rhinitis
  • Significant or unstable cardiovascular disorder
  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: NCT00542880

  Hide Study Locations
Locations
Argentina
Research Site
Monte Grande, Buenos Aires, Argentina
Research Site
Quilmes, Buenos Aires, Argentina
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San Miguel de Tucuman, Tucuman, Argentina
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Ciudad Autonoma de Bs. As., Argentina
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Ciudad de Buenos Aires, Argentina
Australia, New South Wales
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Concord, New South Wales, Australia
Australia, South Australia
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Adelaide, South Australia, Australia
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Daw Park, South Australia, Australia
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Woodville South, South Australia, Australia
Australia, Victoria
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Melbourne, Victoria, Australia
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Parkville, Victoria, Australia
Australia, Western Australia
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Nedlands, Western Australia, Australia
Belgium
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Jambes, Belgium
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Malmedy, Belgium
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Montigny-le-tilleul, Belgium
Brazil
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Porto Alegre, Brasil, Brazil
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Juiz de Fora, MG, Brazil
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Recife, PE, Brazil
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Rio de Janeiro, RJ, Brazil
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Porto Alegre, RS, Brazil
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Florianopolis, Santa Catarina, Brazil
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Santo Andre, SP, Brazil
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Sao Paulo, SP, Brazil
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Rio de Janeiro, Brazil
Denmark
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Aalborg, Denmark
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Alborg, Denmark
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Hellerup, Denmark
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Hvidovre, Denmark
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Kobenhavn Nv, Denmark
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Odense C, Denmark
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Rodovre, Denmark
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Silkeborg, Denmark
Germany
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Berlin, Germany
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Erfurt, Germany
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Leipzig, Germany
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Marburg, Germany
India
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Hyderabad, Andhra Pradesh, India
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Bangalore, Karnataka, India
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Jaipur, Rajasthan, India
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Coimbatore, India
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Noida, India
Philippines
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Manila, Philippines
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Quezon City, Philippines
United Kingdom
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Dartford, Kent, United Kingdom
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Hamilton, Lanarkshire, United Kingdom
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Motherwell, Lanarkshire, United Kingdom
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Cookstown, N. Ireland, United Kingdom
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Limavady, Northern Ireland, United Kingdom
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Newtownabbey, Northern Ireland, United Kingdom
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Barry, South Glamorgan, United Kingdom
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Barry, Vale of Glamorgan, United Kingdom
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Bradford-on-avon, Wiltshire, United Kingdom
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Airdrie, United Kingdom
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Birmingham, United Kingdom
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Blantyre, United Kingdom
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Bolton, United Kingdom
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Carrickfergus, United Kingdom
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Chesterfield, United Kingdom
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Coventry, United Kingdom
Research Site
Hamilton, United Kingdom
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Tomas Andersson, MD AstraZeneca
Principal Investigator: Martyn R Partridge, MD FRCP Faculty of Medicine, Imperial College, NHLI at Charing Cross Hospital, LONDON, UK
  More Information

No publications provided by AstraZeneca

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00542880     History of Changes
Other Study ID Numbers: D5892C00016
Study First Received: October 10, 2007
Results First Received: August 4, 2009
Last Updated: July 27, 2012
Health Authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Australia: Department of Health and Ageing Therapeutic Goods Administration
Belgium: Ministerie Van Sociale Zaken
Brazil: National Health Surveillance Agency
Denmark: Danish Medicines Agency
Germany: Bundesinstitut für Arzneimittel und Medizin
India: Drug Controller General
Philippines: Bureau of Food and Drugs
United Kingdom: Information Processing Unit - Area 6

Keywords provided by AstraZeneca:
COPD
Symbicort
Seretide

Additional relevant MeSH terms:
Lung Diseases
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases
Fluticasone
Budesonide
Formoterol
Salmeterol
Fluticasone, salmeterol drug combination
Symbicort
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Dermatologic Agents
Anti-Allergic Agents

ClinicalTrials.gov processed this record on August 28, 2014