Chronic Obstructive Pulmonary Disease (COPD)Phase 4SPEEDNCT00542880
Evaluation of Onset of Effect in Patients With Severe Chronic Obstructive Pulmonary Disease (COPD) Treated With Symbicort® Compared to Seretide®
A Phase 4 study testing Symbicort Turbuhaler (budesonide/formoterol) 320/9 μg and Seretide Diskus (salmeterol/fluticasone) 50/500 μg in people with Chronic Obstructive Pulmonary Disease (COPD), run by AstraZeneca at 59 sites in 9 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease (COPD)
- What is being tested?
- Symbicort Turbuhaler (budesonide/formoterol) 320/9 μg and Seretide Diskus (salmeterol/fluticasone) 50/500 μg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 442 participants
- Where
- 59 sitesin 9 countries
- Study dates
- Sep 2007to Aug 2008
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Current respiratory tract disorder other than COPD
- History of asthma or rhinitis
- Significant or unstable cardiovascular disorder
Trial locations and contacts
59 sites in 9 countries.
59 sites in 9 countries
United Kingdom17 sites
Research Site
Airdrie
Research Site
Barry, South Glamorgan
Research Site
Barry, Vale of Glamorgan
Research Site
Birmingham
Research Site
Blantyre
Research Site
Bolton
Research Site
Bradford on Avon, Wiltshire
Research Site
Carrickfergus
Research Site
Chesterfield
Research Site
Cookstown, Northern Ireland
Research Site
Coventry
Research Site
Dartford, Kent
Research Site
Hamilton, Lanarkshire
Research Site
Hamilton
Research Site
Limavady, Northern Ireland
Research Site
Motherwell, Lanarkshire
Research Site
Newtownabbey, Northern Ireland
Brazil9 sites
Research Site
Florianópolis, Santa Catarina
Research Site
Juiz de Fora, Minas Gerais
Research Site
Porto Alegre, Brasil
Research Site
Porto Alegre, Rio Grande do Sul
Research Site
Recife, Pernambuco
Research Site
Rio de Janeiro, Rio de Janeiro
Research Site
Rio de Janeiro
Research Site
Santo André, São Paulo
Research Site
São Paulo, São Paulo
Australia7 sites
Research Site
Adelaide, South Australia
Research Site
Concord, New South Wales
Research Site
Daw Park, South Australia
Research Site
Melbourne, Victoria
Research Site
Nedlands, Western Australia
Research Site
Parkville, Victoria
Research Site
Woodville South, South Australia
Denmark7 sites
Research Site
Aalborg
Research Site
Hellerup
Research Site
Hvidovre
Research Site
København NV
Research Site
Odense C
Research Site
Rødovre Municipality
Research Site
Silkeborg
Argentina5 sites
Research Site
Ciudad Autonoma de Bs. As.
Research Site
Ciudad de Buenos Aires
Research Site
Monte Grande, Buenos Aires
Research Site
Quilmes, Buenos Aires
Research Site
San Miguel de Tucumán, Tucumán Province
India5 sites
Research Site
Bangalore, Karnataka
Research Site
Coimbatore
Research Site
Hyderabad, Andhra Pradesh
Research Site
Jaipur, Rajasthan
Research Site
Noida
Germany4 sites
Research Site
Berlin
Research Site
Erfurt
Research Site
Leipzig
Research Site
Marburg
Belgium3 sites
Research Site
Jambes, Belgium
Research Site
Malmedy, Belgium
Research Site
Montigny-le-Tilleul, Belgium
About this study
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.
This study is to assess the effects with two different inhaled respiratory medications with regards to improvement of lung function, symptoms and morning activities.
- Being tested
- Symbicort Turbuhaler (budesonide/formoterol) 320/9 μg, Seretide Diskus (salmeterol/fluticasone) 50/500 μg
- Keywords
- COPD, Symbicort, Seretide
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Symbicort Turbuhaler (budesonide/formoterol) 320/9 μgDrug
Seretide Diskus (salmeterol/fluticasone) 50/500 μgDrug
| Study group | Role | What they receive |
|---|---|---|
| Symbicort Turbuhaler First, then Seretide Diskus | Experimental | Symbicort Turbuhaler (budesonide/formoterol) 320/9 μg First, then Seretide Diskus (salmeterol/fluticasone) 50/500 μg Receives: Drug: Symbicort Turbuhaler (budesonide/formoterol) 320/9 μg; Drug: Seretide Diskus (salmeterol/fluticasone) 50/500 μg |
| Seretide Diskus First, then Symbicort Turbuhaler | Experimental | Seretide Diskus (salmeterol/fluticasone) 50/500 μg First, then Symbicort Turbuhaler (budesonide/formoterol) 320/9 μg Receives: Drug: Symbicort Turbuhaler (budesonide/formoterol) 320/9 μg; Drug: Seretide Diskus (salmeterol/fluticasone) 50/500 μg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak Expiratory Flow (PEF) 5 Minutes After Morning Dose
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.
Measured: Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days
Secondary outcomes (15)
PEF Before Morning Dose
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.
Measured: Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days
PEF 15 Minutes After Morning Dose
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.
Measured: Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days
PEF Before Evening Dose
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.
Measured: 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
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.
Measured: Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days
FEV1 15 Minutes After Morning Dose
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.
Measured: Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days
FEV1 Before Evening Dose
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2007 (estimated)
- Study startSep 2007
- Primary completionAug 2008
- Study completionAug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary Disease (COPD)Studies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 442 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tomas Andersson, MD, Study director, AstraZenecaMartyn R Partridge, MD FRCP, Principal investigator, Faculty of Medicine, Imperial College, NHLI at Charing Cross Hospital, LONDON, UK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00542880
- Sponsor's protocol ID
- D5892C00016
- Acronym
- SPEED
- Status last verified
- Jul 2012
- First submitted
- 10 Oct 2007
- Last updated
- 30 Aug 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Partridge MR, Miravitlles M, Stahl E, Karlsson N, Svensson K, Welte T. Development and validation of the Capacity of Daily Living during the Morning questionnaire and the Global Chest Symptoms Questionnaire in COPD. Eur Respir J. 2010 Jul;36(1):96-104. doi: 10.1183/09031936.00123709. Epub 2009 Nov 6.
PubMed 19897551
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00542880
- Acronym / sponsor ID
- SPEED / D5892C00016
- Keywords
- COPD, Symbicort, Seretide
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 442 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Sep 2007
- Primary completion
- Aug 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 12 Oct 2007 (estimated)
- Results
- Posted 30 Aug 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Symbicort Turbuhaler First, then Seretide Diskus | Experimental | Drug: Symbicort Turbuhaler (budesonide/formoterol) 320/9 μg, Drug: Seretide Diskus (salmeterol/fluticasone) 50/500 μgSymbicort Turbuhaler (budesonide/formoterol) 320/9 μg First, then Seretide Diskus (salmeterol/fluticasone) 50/500 μg |
| Seretide Diskus First, then Symbicort Turbuhaler | Experimental | Drug: Symbicort Turbuhaler (budesonide/formoterol) 320/9 μg, Drug: Seretide Diskus (salmeterol/fluticasone) 50/500 μgSeretide Diskus (salmeterol/fluticasone) 50/500 μg First, then Symbicort Turbuhaler (budesonide/formoterol) 320/9 μg |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- Current respiratory tract disorder other than COPD
- History of asthma or rhinitis
- Significant or unstable cardiovascular disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Symbicort Turbuhaler (budesonide/formoterol) 320/9 μg | Drug | Seretide Diskus First, then Symbicort Turbuhaler, Symbicort Turbuhaler First, then Seretide Diskus |
| Seretide Diskus (salmeterol/fluticasone) 50/500 μg | Drug | Seretide Diskus First, then Symbicort Turbuhaler, Symbicort Turbuhaler First, then Seretide Diskus |
Primary outcome
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.
15 secondary outcomes
PEF Before Morning Dose
Time frame: 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
PEF Before Evening Dose
Time frame: 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
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
FEV1 Before Evening Dose
Time frame: 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
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
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
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
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
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
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
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 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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 19897551Partridge MR, Miravitlles M, Stahl E, Karlsson N, Svensson K, Welte T. Development and validation of the Capacity of Daily Living during the Morning questionnaire and the Global Chest Symptoms Questionnaire in COPD. Eur Respir J. 2010 Jul;36(1):96-104. doi: 10.1183/09031936.00123709. Epub 2009 Nov 6.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tomas Andersson, MD study director
AstraZeneca
Martyn R Partridge, MD FRCP principal investigator
Faculty of Medicine, Imperial College, NHLI at Charing Cross Hospital, LONDON, UK
59 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Symbicort Turbuhaler (budesonide/formoterol) 320/9 μg and Seretide Diskus (salmeterol/fluticasone) 50/500 μg in people with Chronic Obstructive Pulmonary Disease (COPD), run by AstraZeneca at 59 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 59 sites in United Kingdom, Brazil, Australia, Denmark, Argentina and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Aug 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00542880, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2012.