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

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ClinicalTrials.gov Identifier: NCT00542880
Recruitment Status : Completed
First Posted : October 12, 2007
Results First Posted : August 30, 2012
Last Update Posted : August 30, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment 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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 442 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, 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.
Study Start Date : September 2007
Primary Completion Date : August 2008
Study Completion Date : August 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD Lung Diseases
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. 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 ]
    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 :
  1. PEF Before Morning Dose [ Time Frame: Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days ]
    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.

  2. 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 ]
    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.

  3. PEF Before Evening Dose [ Time Frame: Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days ]
    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.

  4. 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 ]
    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.

  5. 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 ]
    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.

  6. FEV1 Before Evening Dose [ Time Frame: Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days ]
    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.

  7. 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 ]
    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.

  8. 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 ]
    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.

  9. 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 ]
    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.

  10. 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 ]
    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.

  11. 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 ]
    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.

  12. 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 ]
    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.

  13. 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 ]
    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.

  14. 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 ]
    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.

  15. 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 ]
    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.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00542880


  Show 60 Study Locations
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

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
First Posted: October 12, 2007    Key Record Dates
Results First Posted: August 30, 2012
Last Update Posted: August 30, 2012
Last Verified: July 2012

Keywords provided by AstraZeneca:
COPD
Symbicort
Seretide

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Fluticasone
Budesonide
Formoterol Fumarate
Salmeterol Xinafoate
Fluticasone Propionate, Salmeterol Xinafoate Drug Combination
Budesonide, Formoterol Fumarate Drug Combination
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents
Anti-Allergic Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Sympathomimetics