Bronchial AsthmaPhase 3ESTHERNCT00536731
Symbicort Rapihaler Therapeutic Equivalence Study
A Phase 3 study testing Symbicort Turbuhaler, Symbicort pMDI and Pulmicort Turbuhaler in people with Bronchial Asthma, run by AstraZeneca at 48 sites in 4 countries.
Trial summary
The purpose of the this study is to evaluate the efficacy and safety of 2 actuations Symbicort®pMDI® 40/2.25 μg twice daily compared with1 inhalation Symbicort Turbuhaler® 80/4.5 μg twice daily and 1 inhalation Pulmicort®Turbuhaler® 100 μg twice daily for 6 weeks. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Bronchial Asthma
- What is being tested?
- Symbicort Turbuhaler, Symbicort pMDI and Pulmicort Turbuhaler
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 742 participants
- Where
- 48 sitesin 4 countries
- Study dates
- Sep 2007to Apr 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Asthma clinically diagnosed since at least 6 months.
- Lung function values measured ≥ 50% and ≤ 90% of predicted normal.
- Patients with reversible airway obstruction Daily use of inhaled steroids (any brand) for >3 months.
Who cannot join
- Use of oral, rectal or parenteral steroids within 30 days prior to start of study.
- Respiratory infection affecting the asthma, as judged by the investigator, within 30 days prior to start of randomised treatment.
- Any significant disease or disorder which, in the opinion of the investigator, may either put the patient at risk because of participation in the study, or may influence the results of the study or the patient's ability to participate in the study.
Trial locations and contacts
48 sites in 4 countries.
48 sites in 4 countries
Poland18 sites
Research Site
Bialystok
Research Site
Bielsko-Biala
Research Site
Bydgoszcz
Research Site
Chodzież
Research Site
Chrzanów
Research Site
Karpacz
Research Site
Krakow
Research Site
Lodz
Research Site
Łomża
Research Site
Lublin
Research Site
Ostrów Wielkopolski
Research Site
Poznan
Research Site
Skierniewice
Research Site
Szczecin
Research Site
Tarnów
Research Site
Turek
Research Site
Wodzisław Śląski
Research Site
Wroclaw
Hungary13 sites
Research Site
Balassagyarmat
Research Site
Budapest
Research Site
Cegléd
Research Site
Debrecen
Research Site
Deszk
Research Site
Győr
Research Site
Gyula
Research Site
Kaposvár
Research Site
Nyíregyháza
Research Site
Szarvas
Research Site
Százhalombatta
Research Site
Szeged
Research Site
Törökbálint
Czechia12 sites
Research Site
Benesov U Prahy
Research Site
Hradec Králové
Research Site
Jihlava
Research Site
Kladno
Research Site
Kolín
Research Site
Kutná Hora
Research Site
Litoměřice
Research Site
Neratovice
Research Site
Pardubice
Research Site
Prague
Research Site
Rokycany
Research Site
Strakonice
Bulgaria5 sites
Research Site
Pleven
Research Site
Plovdiv
Research Site
Rousse
Research Site
Sofia
Research Site
Varna
About this study
Official title: A 6-week, Phase III, Double-blind, Randomized, Multi-centre, Parallel-group Study Evaluating the Efficacy and Safety of 2 Actuations Symbicort®pMDI® 40/2.25 μg Twice Daily Compared With 1 Inhalation Symbicort Turbuhaler® 80/4.5 μg Twice Daily and 1 Inhalation Pulmicort®Turbuhaler® 100 μg Twice Daily
The purpose of the this study is to evaluate the efficacy and safety of 2 actuations Symbicort®pMDI® 40/2.25 μg twice daily compared with1 inhalation Symbicort Turbuhaler® 80/4.5 μg twice daily and 1 inhalation Pulmicort®Turbuhaler® 100 μg twice daily for 6 weeks.
- Conditions
- Bronchial Asthma
- Being tested
- Symbicort Turbuhaler, Symbicort pMDI, Pulmicort Turbuhaler
- Keywords
- Asthma, Symbicort
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Symbicort TurbuhalerDrug
Symbicort Turbuhaler® 80/4.5 μg 1 Inhalation Twice Daily
Symbicort pMDIDrug
Symbicort®pMDI® 40/2.25 μg 2 Actuations Twice Daily
Pulmicort TurbuhalerDrug
Pulmicort®Turbuhaler® 100 μg 1 Inhalation Twice Daily
| Study group | Role | What they receive |
|---|---|---|
| Symbicort pMDI | Active comparator | Symbicort®pMDI® 40/2.25 μg 2 Actuations Twice Daily Receives: Drug: Symbicort pMDI |
| Symbicort Turbuhaler | Active comparator | Symbicort Turbuhaler® 80/4.5 μg 1 Inhalation Twice Daily Receives: Drug: Symbicort Turbuhaler |
| Pulmicort Turbuhaler | Active comparator | Pulmicort®Turbuhaler® 100 μg 1 Inhalation Twice Daily Receives: Drug: Pulmicort Turbuhaler |
What is being measured
The primary outcome is the main question the study is designed to answer.
Morning Peak Expiratory Flow (PEF)
Change in the Morning PEF from baseline (calculated as a mean using all available data for the 10 last days of run-in period) to week 6 (calculated as a mean using all available data after randomisation). No imputation of missing data was performed
Measured: Baseline to 6 weeks
Secondary outcomes (12)
Evening Peak Expiratory Flow (PEF)
Change in the Evening PEF from baseline (calculated as a mean using all available data for the 10 last days of run-in period) to week 6 (calculated as a mean using all available data after randomisation). No imputation of missing data was performed
Measured: Baseline to 6 weeks
Asthma Symptom Score, Night
Change in the Asthma Symptom Score (Night) from baseline (calculated as a mean using all available data for the 10 last days of run-in period) to week 6 (calculated as a mean using all available data after randomization, with run-in values as covariate). No imputation of missing data was performed. Daily scale:0 = No symptoms; 1 = Mild symptoms; 2 = Moderate symptoms; 3 = Severe symptoms.
Measured: Baseline to 6 weeks
Asthma Symptom Score, Day
Change in the Asthma Symptom Score (Day) from baseline (calculated as a mean using all available data for the 10 last days of run-in period) to week 6 (calculated as a mean using all available data after randomization, with run-in values as covariate). No imputation of missing data was performed. Daily scale:0 = No symptoms; 1 = Mild symptoms; 2 = Moderate symptoms; 3 = Severe symptoms.
Measured: Baseline to 6 weeks
Asthma Symptom Score, Total
Change in the Asthma Symptom Score (Total) from baseline (calculated as a mean using all available data for the 10 last days of run-in period) to week 6 (calculated as a mean using all available data after randomization, with run-in values as covariate). No imputation of missing data was performed. Daily scale:0 = No symptoms; 1 = Mild symptoms; 2 = Moderate symptoms; 3 = Severe symptoms.
Measured: Baseline to 6 weeks
Percentage of Nights With Awakenings Due to Asthma
Change in the Percentage of Nights With Awakenings Due to Asthma from baseline (calculated as a mean using all available data for the 10 last days of run-in period) to week 6 (calculated as a mean using all available data after randomization, with run-in values as covariate). No imputation of missing data was performed. The participants answered "Yes" or "No" whether she/he woke up during the night due to asthma.
Measured: Baseline and 6 weeks
Use of Rescue Medication, Night
Change in the Use of Rescue Medication (Night) from baseline (calculated as a mean using all available data for the 10 last days of run-in period) to week 6 (calculated as a mean using all available data after randomization, with run-in values as covariate). No imputation of missing data was performed
Measured: Baseline to 6 weeks
Use of Rescue Medication, Day
Change in the Use of Rescue Medication (Day) from baseline (calculated as a mean using all available data for the 10 last days of run-in period) to week 6 (calculated as a mean using all available data after randomization, with run-in values as covariate). No imputation of missing data was performed
Measured: Baseline to 6 weeks
Use of Rescue Medication, Total
Change in the Use of Rescue Medication (Total) from baseline (calculated as a mean using all available data for the 10 last days of run-in period) to week 6 (calculated as a mean using all available data after randomization, with run-in values as covariate). No imputation of missing data was performed
Measured: Baseline to 6 weeks
Percentage of Symptom-free Days
Change in the Percentage of Symptom-free Days from baseline (calculated as a mean using all available data for the 10 last days of run-in period) to week 6 (calculated as a mean using all available data after randomization, with run-in values as covariate). No imputation of missing data was performed. Symptom-free Day: no symptoms (asthma symptom score=0) night and day, and no awakenings due to asthma.
Measured: Baseline to 6 weeks
Percentage of Asthma Control Days
Change in the Percentage of Symptom Control Days from baseline (calculated as a mean using all available data for the 10 last days of run-in period) to week 6 (calculated as a mean using all available data after randomization, with run-in values as covariate). No imputation of missing data was performed. Asthma Control Day: no symptoms (asthma symptom score=0) night and day, no awakenings due to asthma, no rescue medication.
Measured: Baseline to 6 weeks
Percentage of Rescue Free Days
Change in the Percentage of Rescue Free Days from baseline (calculated as a mean using all available data for the 10 last days of run-in period) to week 6 (calculated as a mean using all available data after randomization, with run-in values as covariate). No imputation of missing data was performed. Rescue-free Day defined as day and night with no use of rescue medication.
Measured: Baseline to 6 weeks
Forced Expiratory Volume in 1 Second (FEV1)
Change in the FEV1from baseline to week 6 (calculated as a mean using all available data after randomization)
Measured: Baseline to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2007 (estimated)
- Study startSep 2007
- Primary completionApr 2008
- Study completionApr 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 Bronchial AsthmaStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 742 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tomas Andersson, Study director, AstraZenecaAkos Somoskovi, Principal investigator, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00536731
- Sponsor's protocol ID
- D5897C00003
- Acronym
- ESTHER
- Status last verified
- Aug 2012
- First submitted
- 27 Sep 2007
- Last updated
- 15 Aug 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 6-week, Phase III, Double-blind, Randomized, Multi-centre, Parallel-group Study Evaluating the Efficacy and Safety of 2 Actuations Symbicort®pMDI® 40/2.25 μg Twice Daily Compared With 1 Inhalation Symbicort Turbuhaler® 80/4.5 μg Twice Daily and 1 Inhalation Pulmicort®Turbuhaler® 100 μg Twice Daily
- ClinicalTrials.gov ID
- NCT00536731
- Acronym / sponsor ID
- ESTHER / D5897C00003
- Conditions
- Bronchial Asthma
- Keywords
- Asthma, Symbicort
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 742 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Sep 2007
- Primary completion
- Apr 2008 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 28 Sep 2007 (estimated)
- Results
- Posted 15 Aug 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the this study is to evaluate the efficacy and safety of 2 actuations Symbicort®pMDI® 40/2.25 μg twice daily compared with1 inhalation Symbicort Turbuhaler® 80/4.5 μg twice daily and 1 inhalation Pulmicort®Turbuhaler® 100 μg twice daily for 6 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Symbicort pMDI | Active comparator | Drug: Symbicort pMDISymbicort®pMDI® 40/2.25 μg 2 Actuations Twice Daily |
| Symbicort Turbuhaler | Active comparator | Drug: Symbicort TurbuhalerSymbicort Turbuhaler® 80/4.5 μg 1 Inhalation Twice Daily |
| Pulmicort Turbuhaler | Active comparator | Drug: Pulmicort TurbuhalerPulmicort®Turbuhaler® 100 μg 1 Inhalation Twice Daily |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Asthma clinically diagnosed since at least 6 months.
- Lung function values measured ≥ 50% and ≤ 90% of predicted normal.
- Patients with reversible airway obstruction Daily use of inhaled steroids (any brand) for >3 months.
Key exclusion criteria (3 listed)
- Use of oral, rectal or parenteral steroids within 30 days prior to start of study.
- Respiratory infection affecting the asthma, as judged by the investigator, within 30 days prior to start of randomised treatment.
- Any significant disease or disorder which, in the opinion of the investigator, may either put the patient at risk because of participation in the study, or may influence the results of the study or the patient's ability to participate in the study.
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 TurbuhalerSymbicort Turbuhaler® 80/4.5 μg 1 Inhalation Twice Daily | Drug | Symbicort Turbuhaler |
| Symbicort pMDISymbicort®pMDI® 40/2.25 μg 2 Actuations Twice Daily | Drug | Symbicort pMDI |
| Pulmicort TurbuhalerPulmicort®Turbuhaler® 100 μg 1 Inhalation Twice Daily | Drug | Pulmicort Turbuhaler |
Primary outcome
Morning Peak Expiratory Flow (PEF)
Time frame: Baseline to 6 weeks
Change in the Morning PEF from baseline (calculated as a mean using all available data for the 10 last days of run-in period) to week 6 (calculated as a mean using all available data after randomisation). No imputation of missing data was performed
12 secondary outcomes
Evening Peak Expiratory Flow (PEF)
Time frame: Baseline to 6 weeks
Asthma Symptom Score, Night
Time frame: Baseline to 6 weeks
Asthma Symptom Score, Day
Time frame: Baseline to 6 weeks
Asthma Symptom Score, Total
Time frame: Baseline to 6 weeks
Percentage of Nights With Awakenings Due to Asthma
Time frame: Baseline and 6 weeks
Use of Rescue Medication, Night
Time frame: Baseline to 6 weeks
Use of Rescue Medication, Day
Time frame: Baseline to 6 weeks
Use of Rescue Medication, Total
Time frame: Baseline to 6 weeks
Percentage of Symptom-free Days
Time frame: Baseline to 6 weeks
Percentage of Asthma Control Days
Time frame: Baseline to 6 weeks
Percentage of Rescue Free Days
Time frame: Baseline to 6 weeks
Forced Expiratory Volume in 1 Second (FEV1)
Time frame: Baseline to 6 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2012.
- 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.
Tomas Andersson study director
AstraZeneca
Akos Somoskovi principal investigator
AstraZeneca
48 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Symbicort Turbuhaler, Symbicort pMDI and Pulmicort Turbuhaler in people with Bronchial Asthma, run by AstraZeneca at 48 sites in 4 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 15 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 48 sites in Poland, Hungary, Czechia, Bulgaria. 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 15 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?
Morning Peak Expiratory Flow (PEF) (time frame: Baseline to 6 weeks). 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 15 Aug 2012.