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

July 27, 2012 updated by: AstraZeneca

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.

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
442

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Ciudad Autonoma de Bs. As., Argentina
        • Research Site
      • Ciudad de Buenos Aires, Argentina
        • Research Site
    • Buenos Aires
      • Monte Grande, Buenos Aires, Argentina
        • Research Site
      • Quilmes, Buenos Aires, Argentina
        • Research Site
    • Tucuman
      • San Miguel de Tucuman, Tucuman, Argentina
        • Research Site
  • Australia
    • New South Wales
      • Concord, New South Wales, Australia
        • Research Site
    • South Australia
      • Adelaide, South Australia, Australia
        • Research Site
      • Daw Park, South Australia, Australia
        • Research Site
      • Woodville South, South Australia, Australia
        • Research Site
    • Victoria
      • Melbourne, Victoria, Australia
        • Research Site
      • Parkville, Victoria, Australia
        • Research Site
    • Western Australia
      • Nedlands, Western Australia, Australia
        • Research Site
  • Belgium
      • Jambes, Belgium
        • Research Site
      • Malmedy, Belgium
        • Research Site
      • Montigny-le-tilleul, Belgium
        • Research Site
  • Brazil
      • Rio de Janeiro, Brazil
        • Research Site
    • Brasil
      • Porto Alegre, Brasil, Brazil
        • Research Site
    • MG
      • Juiz de Fora, MG, Brazil
        • Research Site
    • PE
      • Recife, PE, Brazil
        • Research Site
    • RJ
      • Rio de Janeiro, RJ, Brazil
        • Research Site
    • RS
      • Porto Alegre, RS, Brazil
        • Research Site
    • SP
      • Santo Andre, SP, Brazil
        • Research Site
      • Sao Paulo, SP, Brazil
        • Research Site
    • Santa Catarina
      • Florianopolis, Santa Catarina, Brazil
        • Research Site
  • Denmark
      • Aalborg, Denmark
        • Research Site
      • Alborg, Denmark
        • Research Site
      • Hellerup, Denmark
        • Research Site
      • Hvidovre, Denmark
        • Research Site
      • Kobenhavn Nv, Denmark
        • Research Site
      • Odense C, Denmark
        • Research Site
      • Rodovre, Denmark
        • Research Site
      • Silkeborg, Denmark
        • Research Site
  • Germany
      • Berlin, Germany
        • Research Site
      • Erfurt, Germany
        • Research Site
      • Leipzig, Germany
        • Research Site
      • Marburg, Germany
        • Research Site
  • India
      • Coimbatore, India
        • Research Site
      • Noida, India
        • Research Site
    • Andhra Pradesh
      • Hyderabad, Andhra Pradesh, India
        • Research Site
    • Karnataka
      • Bangalore, Karnataka, India
        • Research Site
    • Rajasthan
      • Jaipur, Rajasthan, India
        • Research Site
  • Philippines
      • Manila, Philippines
        • Research Site
      • Quezon City, Philippines
        • Research Site
  • United Kingdom
      • Airdrie, United Kingdom
        • Research Site
      • Birmingham, United Kingdom
        • Research Site
      • Blantyre, United Kingdom
        • Research Site
      • Bolton, United Kingdom
        • Research Site
      • Carrickfergus, United Kingdom
        • Research Site
      • Chesterfield, United Kingdom
        • Research Site
      • Coventry, United Kingdom
        • Research Site
      • Hamilton, United Kingdom
        • Research Site
    • Kent
      • Dartford, Kent, United Kingdom
        • Research Site
    • Lanarkshire
      • Hamilton, Lanarkshire, United Kingdom
        • Research Site
      • Motherwell, Lanarkshire, United Kingdom
        • Research Site
    • N. Ireland
      • Cookstown, N. Ireland, United Kingdom
        • Research Site
    • Northern Ireland
      • Limavady, Northern Ireland, United Kingdom
        • Research Site
      • Newtownabbey, Northern Ireland, United Kingdom
        • Research Site
    • South Glamorgan
      • Barry, South Glamorgan, United Kingdom
        • Research Site
    • Vale of Glamorgan
      • Barry, Vale of Glamorgan, United Kingdom
        • Research Site
    • Wiltshire
      • Bradford-on-avon, Wiltshire, United Kingdom
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days
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.
Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days
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.
Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days
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.
Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days
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.
Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days
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.
Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days
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.
Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days
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.
Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days
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.
Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days
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.
Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days
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.
Baseline (run-in, and washout) and day 1 of treatment period
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.
Baseline (run-in, and washout) and day 1 of treatment period
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.
Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days
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.
Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days
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.
Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
AstraZeneca

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2007

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2008

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2008

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 10, 2007

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 10, 2007

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 12, 2007

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 30, 2012

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 27, 2012

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • D5892C00016

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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