Asthma, BronchialPhase 3NCT00385593
Symbicort Single Inhaler Therapy vs Conventional Best Practice for the Treatment of Persistent Asthma in Adults
A Phase 3 study testing Symbicort (budesonide/formoterol) Turbuhaler and Conventional treatment in people with Asthma, Bronchial, run by AstraZeneca at 52 sites in Spain.
Trial summary
This study is intended to extend the knowledge of Symbicort Single Inhaler Therapy into a more general setting in order to assess the real-life impact of introducing this new treatment concept. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Asthma, Bronchial
- What is being tested?
- Symbicort (budesonide/formoterol) Turbuhaler and Conventional treatment
- How many people
- 654 participants
- Where
- 52 sitesSpain
- Study dates
- Sep 2006to Oct 2008
- Phase
- Phase 3
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Minimum of 3 months history of asthma, diagnosed according to the American Thoracic Society (ATS) definition (9).
- Prescribed inhaled GCS at a dose of 400μg/day of budesonide (or equivalents)and within the approved label for the relevant drug during the last 3 months prior to Visit 1.
- Either daily maintenance treatment with both inhaled GCS and LABA or daily treatment with inhaled GCS alone (i.e. without LABA)
- A history of suboptimal asthma control the month prior to enrolment as judged by the investigator
- Use of ≥3 inhalations of as needed medication for symptom relief during the last 7 days before enrolment
Who cannot join
- Previous treatment with Symbicort Single Inhaler;
- Use of any b-blocking agent, including eye-drops and oral GCS as maintenance treatment.
- Known or suspected hypersensitivity to study therapy or excipients.
- A history of smoking ≥ 10 pack years.
- Asthma exacerbation requiring change in asthma treatment during the last 14 days prior to or at Visit 1.
Trial locations and contacts
52 sites in 1 country.
52 sites in 1 country
Spain52 sites
Research Site
A Coruña
Research Site
Alagón
Research Site
Alicante
Research Site
Almoradí
Research Site
Barcelona
Research Site
Burgos
Research Site
Cadiz
Research Site
Caravaca
Research Site
Cartagena
Research Site
Córdoba
Research Site
Coslada
Research Site
Donostia / San Sebastian
Research Site
Dos Hermanas
Research Site
Elche
Research Site
Fuencarral
Research Site
Fuenlabrada
Research Site
Galdakao
Research Site
Gallur
Research Site
Gandia
Research Site
Getafe
Research Site
Gijón
Research Site
Granada
Research Site
Huelva
Research Site
Huesca
Research Site
Idiazabal
Research Site
Jaén
Research Site
Lugo
Research Site
Madrid
Research Site
Málaga
Research Site
Mataró
Research Site
Oviedo
Research Site
Pamplona
Research Site
Pinto
Research Site
Pozuelo de Alarcón
Research Site
Sagunto
Research Site
Salamanca
Research Site
San Juan
Research Site
Santander
Research Site
Santiago
Research Site
Santiago de Compostela
Research Site
Seville
Research Site
Terrassa
Research Site
Valdemoro
Research Site
Valencia
Research Site
Valladolid
Research Site
Vigo
Research Site
Viladecans
Research Site
Vilanova
Research Site
Villabona
Research Site
Villanueva de la Cañada
Research Site
Vitoria-Gasteiz
Research Site
Zaragoza
About this study
Official title: A Comparison of Symbicort Single Inhaler Therapy (Symbicort Turbuhaler 160/4.5 Micrograms, 1 Inhalation b.i.d. Plus as Needed) and Conventional Best Practice for the Treatment of Persistent Asthma in Adults - a 26-week, Randomised, Open-label, Parallel-group, Multicentre Study. Study SPAIN
This study is intended to extend the knowledge of Symbicort Single Inhaler Therapy into a more general setting in order to assess the real-life impact of introducing this new treatment concept. The study will compare the Symbicort Single Inhaler Therapy concept with a conventional stepwise treatment regimen according to the investigator's judgement in patients who present with symptoms on inhaled glucocorticosteroids (GCS) treatment or who require and are already on treatment with a combination of inhaled and long-acting B2 agonists (LABA).
- Conditions
- Asthma, Bronchial
- Being tested
- Symbicort (budesonide/formoterol) Turbuhaler, Conventional treatment
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Symbicort (budesonide/formoterol) TurbuhalerDrug
Conventional treatmentDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to First Severe Asthma Exacerbation
Severe asthma exacerbation is defined as deterioration in asthma leading to at least one of Hospitalization/Emergency room (or equivalent) treatment due to asthma or Oral Glucocorticosteroids (GCS) treatment for at least 3 days.
Measured: Baseline up to 6 months
Secondary outcomes (5)
Total Number of Severe Exacerbations
Severe asthma exacerbation is defined as deterioration in asthma leading to at least one of Hospitalization/Emergency room (or equivalent) treatment due to asthma or Oral (GCS) treatment for at least 3 days.
Measured: Baseline up to 6 months
Mean Use of as Needed Medication
Mean use of as needed medication during the treatment period
Measured: Baseline up to 6 months
Use of Inhaled Steroids
Mean micrograms/day of inhaled steroids (beclomethasone dipropionate equivalents)
Measured: Baseline up to 6 months
Change in the Asthma Control Questionnaire(ACQ) Score
The ACQ is a 7-point scale with scores ranging from 0 (very well controlled) to 6 (very badly controlled)
Measured: Daily 14 days prior to each of visit 2-4
Peak Expiratory Flow (PEF)
Peak expiratory flow (PEF)
Measured: 6 months (end of the study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2006 (estimated)
- Study startSep 2006
- Study completionOct 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.
- Other trials for Asthma, BronchialStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 654 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Carlos Barcina, MD, Study director, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00385593
- Sponsor's protocol ID
- D5890L00010
- Other IDs
- 2005-005974-64, SPAIN, 2005
- Status last verified
- Nov 2010
- First submitted
- 6 Oct 2006
- Last updated
- 16 Dec 2010
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Symbicort Single Inhaler Therapy (Symbicort Turbuhaler 160/4.5 Micrograms, 1 Inhalation b.i.d. Plus as Needed) and Conventional Best Practice for the Treatment of Persistent Asthma in Adults - a 26-week, Randomised, Open-label, Parallel-group, Multicentre Study. Study SPAIN
- ClinicalTrials.gov ID
- NCT00385593
- Acronym / sponsor ID
- D5890L00010
- Conditions
- Asthma, Bronchial
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 654 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Sep 2006
- Study completion
- Oct 2008 (actual)
- First posted
- 9 Oct 2006 (estimated)
- Results
- Posted 17 Nov 2009
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 intended to extend the knowledge of Symbicort Single Inhaler Therapy into a more general setting in order to assess the real-life impact of introducing this new treatment concept. The study will compare the Symbicort Single Inhaler Therapy concept with a conventional stepwise treatment regimen according to the investigator's judgement in patients who present with symptoms on inhaled glucocorticosteroids (GCS) treatment or who require and are already on treatment with a combination of inhaled and long-acting B2 agonists (LABA).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Minimum of 3 months history of asthma, diagnosed according to the American Thoracic Society (ATS) definition (9).
- Prescribed inhaled GCS at a dose of 400μg/day of budesonide (or equivalents)and within the approved label for the relevant drug during the last 3 months prior to Visit 1.
- Either daily maintenance treatment with both inhaled GCS and LABA or daily treatment with inhaled GCS alone (i.e. without LABA)
- A history of suboptimal asthma control the month prior to enrolment as judged by the investigator
- Use of ≥3 inhalations of as needed medication for symptom relief during the last 7 days before enrolment
Key exclusion criteria (5 listed)
- Previous treatment with Symbicort Single Inhaler;
- Use of any b-blocking agent, including eye-drops and oral GCS as maintenance treatment.
- Known or suspected hypersensitivity to study therapy or excipients.
- A history of smoking ≥ 10 pack years.
- Asthma exacerbation requiring change in asthma treatment during the last 14 days prior to or at Visit 1.
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 (budesonide/formoterol) Turbuhaler | Drug | – |
| Conventional treatment | Drug | – |
Primary outcome
Time to First Severe Asthma Exacerbation
Time frame: Baseline up to 6 months
Severe asthma exacerbation is defined as deterioration in asthma leading to at least one of Hospitalization/Emergency room (or equivalent) treatment due to asthma or Oral Glucocorticosteroids (GCS) treatment for at least 3 days.
5 secondary outcomes
Total Number of Severe Exacerbations
Time frame: Baseline up to 6 months
Mean Use of as Needed Medication
Time frame: Baseline up to 6 months
Use of Inhaled Steroids
Time frame: Baseline up to 6 months
Change in the Asthma Control Questionnaire(ACQ) Score
Time frame: Daily 14 days prior to each of visit 2-4
Peak Expiratory Flow (PEF)
Time frame: 6 months (end of the study)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2010.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Carlos Barcina, MD study director
AstraZeneca
52 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Symbicort (budesonide/formoterol) Turbuhaler and Conventional treatment in people with Asthma, Bronchial, run by AstraZeneca at 52 sites in Spain.
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 5 inclusion and 5 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: stopped early, as of the sponsor's last update on 16 Dec 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 52 sites in Spain. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 17 Nov 2009). 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?
Time to First Severe Asthma Exacerbation (time frame: Baseline up to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Dec 2010.