AsthmaPhase 3NCT00837967
Study to Investigate the Safety and Efficacy of High Dose of Symbicort® SMART in Japanese Patients
A Phase 3 study testing Symbicort Turbuhaler and Terbutaline Turbuhaler in people with Asthma, run by AstraZeneca at 2 sites in Japan.
Trial summary
The primary objective of the study is to compare the tolerability of Symbicort® Turbuhaler® 160/4.5 μg 10 inhalations with terbutaline Turbuhaler® 0.4 mg 10 inhalations for 3 days on top of Symbicort® Turbuhaler® 160/4.5 μg 1 inhalation twice a day (bid) in adult asthma patients. Read more about this study
- Who is it for?
- Ages 16 to 65 years
- Conditions the study is for
- Asthma
- What is being tested?
- Symbicort Turbuhaler and Terbutaline Turbuhaler
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 2 sitesJapan
- Study dates
- Jan 2009to Jul 2009
- 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 16 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Provision of informed consent prior to any study specific procedures
- A minimum of 6 months documented history of asthma according to the JGL2006/GINA2006 definition
- FEV1> 70% of predicted normal value pre-bronchodilator
Who cannot join
- Having a known or suspected allergy to study therapy (active drugs or additive)
- Having a known clinical history of hypertension, relevant arrhythmias or other heart disease, eg, ischemic heart disease, cardiomyopathy, valvular heart disease, or heart failure
- Having been treated with oral, parenteral or rectal glucocorticoids within 4 weeks, or with depot parenteral glucocorticoids within 3 months
- Respiratory infection significantly affecting the asthma, as judged by the investigator within 4 weeks
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: A Comparison of Tolerability of 10 Inhalations of Symbicort® Turbuhaler® 160/4.5 μg and 10 Inhalations of Terbutaline Turbuhaler® 0.4 mg on Top of Symbicort® Turbuhaler® 160/4.5 μg 1 Inhalation Bid, Randomized, Double-blind, Cross Over, Phase III Study in Japanese Adults Asthma Patients
The primary objective of the study is to compare the tolerability of Symbicort® Turbuhaler® 160/4.5 μg 10 inhalations with terbutaline Turbuhaler® 0.4 mg 10 inhalations for 3 days on top of Symbicort® Turbuhaler® 160/4.5 μg 1 inhalation twice a day (bid) in adult asthma patients.
- Conditions
- Asthma
- Being tested
- Symbicort Turbuhaler, Terbutaline Turbuhaler
- Keywords
- Asthma, Symbicort Turbuhaler
- 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
160/4.5μg for 3 days
Terbutaline TurbuhalerDrug
0.4 mg for 3 days
| Study group | Role | What they receive |
|---|---|---|
| First Symbicort, then Terbutaline | Experimental | Symbicort Turbuhaler 160/4.5μg for 3 days First , then Terbutaline Turbuhaler 0.4 mg for 3 days Receives: Drug: Symbicort Turbuhaler; Drug: Terbutaline Turbuhaler |
| First Turbuhaler, then Symbicort | Experimental | Terbutaline Turbuhaler 0.4 mg for 3 days First, then Symbicort Turbuhaler 160/4.5μg for 3 days, Receives: Drug: Symbicort Turbuhaler; Drug: Terbutaline Turbuhaler |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events
Total number of adverse events
Measured: 3 days
Serum Potassium - Average Concentration From Trapezoidal Area Under the Curve (AUC)
The mean AUC value was calculated as AUC (calculated using the trapezoidal method) divided by the length of the sampling period.
Measured: up to 740 min after start dosing for each treatment day
Blood Glucose - Average Concentration From Trapezoidal Area Under the Curve (AUC)
The mean AUC value was calculated as AUC (calculated using the trapezoidal method) divided by the length of the sampling period.
Measured: up to 140 min after start dosing for each treatment day
Electrocardiogram (ECG)- Average Trapezoidal Area Under the Curve (AUC)
The mean AUC of QTcF (ECG interval measured from the beginning of the Q wave to the end of the T wave, corrected for heart rate using Fridericia's formula)was calculated as AUC (calculated using the trapezoidal method) divided by the length of the sampling period.
Measured: up to 740 min after start dosing for each treatment day
Vital Sign (Blood Pressure)- Average Trapezoidal Area Under the Curve (AUC)
The mean AUC value was calculated as AUC (calculated using the trapezoidal method) divided by the length of the sampling period.
Measured: up to 740 min after start dosing for each treatment day
Vital Sign (Pulse Rate)- Average Trapezoidal Area Under the Curve (AUC)
The mean AUC value was calculated as AUC (calculated using the trapezoidal method) divided by the length of the sampling period.
Measured: up to 740 min after start dosing for each treatment day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2009 (estimated)
- Study startJan 2009
- Primary completionJul 2009
- Study completionJul 2009
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 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
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tomas Andersson, MD, Study director, AstraZeneca R&D Lund
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00837967
- Sponsor's protocol ID
- D589LC00003
- Status last verified
- Aug 2012
- First submitted
- 5 Feb 2009
- Last updated
- 29 Aug 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Saito T, Hasunuma T. Safety and tolerability of high-dose budesonide/formoterol via Turbuhaler(R) in Japanese patients with asthma: a randomized, double-blind, crossover, active comparator-controlled, phase III study. Clin Drug Investig. 2012 Jan 1;32(1):51-61. doi: 10.2165/11595440-000000000-00000.
PubMed 22024920
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Tolerability of 10 Inhalations of Symbicort® Turbuhaler® 160/4.5 μg and 10 Inhalations of Terbutaline Turbuhaler® 0.4 mg on Top of Symbicort® Turbuhaler® 160/4.5 μg 1 Inhalation Bid, Randomized, Double-blind, Cross Over, Phase III Study in Japanese Adults Asthma Patients
- ClinicalTrials.gov ID
- NCT00837967
- Acronym / sponsor ID
- D589LC00003
- Conditions
- Asthma
- Keywords
- Asthma, Symbicort Turbuhaler
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Jan 2009
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 6 Feb 2009 (estimated)
- Results
- Posted 29 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 primary objective of the study is to compare the tolerability of Symbicort® Turbuhaler® 160/4.5 μg 10 inhalations with terbutaline Turbuhaler® 0.4 mg 10 inhalations for 3 days on top of Symbicort® Turbuhaler® 160/4.5 μg 1 inhalation twice a day (bid) in adult asthma patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| First Symbicort, then Terbutaline | Experimental | Drug: Symbicort Turbuhaler, Drug: Terbutaline TurbuhalerSymbicort Turbuhaler 160/4.5μg for 3 days First , then Terbutaline Turbuhaler 0.4 mg for 3 days |
| First Turbuhaler, then Symbicort | Experimental | Drug: Symbicort Turbuhaler, Drug: Terbutaline TurbuhalerTerbutaline Turbuhaler 0.4 mg for 3 days First, then Symbicort Turbuhaler 160/4.5μg for 3 days, |
Who may qualify
- Ages
- 16 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Provision of informed consent prior to any study specific procedures
- A minimum of 6 months documented history of asthma according to the JGL2006/GINA2006 definition
- FEV1> 70% of predicted normal value pre-bronchodilator
Key exclusion criteria (4 listed)
- Having a known or suspected allergy to study therapy (active drugs or additive)
- Having a known clinical history of hypertension, relevant arrhythmias or other heart disease, eg, ischemic heart disease, cardiomyopathy, valvular heart disease, or heart failure
- Having been treated with oral, parenteral or rectal glucocorticoids within 4 weeks, or with depot parenteral glucocorticoids within 3 months
- Respiratory infection significantly affecting the asthma, as judged by the investigator within 4 weeks
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 Turbuhaler160/4.5μg for 3 days | Drug | First Symbicort, then Terbutaline, First Turbuhaler, then Symbicort |
| Terbutaline Turbuhaler0.4 mg for 3 days | Drug | First Symbicort, then Terbutaline, First Turbuhaler, then Symbicort |
Primary outcome
Adverse Events
Time frame: 3 days
Total number of adverse events
Serum Potassium - Average Concentration From Trapezoidal Area Under the Curve (AUC)
Time frame: up to 740 min after start dosing for each treatment day
The mean AUC value was calculated as AUC (calculated using the trapezoidal method) divided by the length of the sampling period.
Blood Glucose - Average Concentration From Trapezoidal Area Under the Curve (AUC)
Time frame: up to 140 min after start dosing for each treatment day
The mean AUC value was calculated as AUC (calculated using the trapezoidal method) divided by the length of the sampling period.
Electrocardiogram (ECG)- Average Trapezoidal Area Under the Curve (AUC)
Time frame: up to 740 min after start dosing for each treatment day
The mean AUC of QTcF (ECG interval measured from the beginning of the Q wave to the end of the T wave, corrected for heart rate using Fridericia's formula)was calculated as AUC (calculated using the trapezoidal method) divided by the length of the sampling period.
Vital Sign (Blood Pressure)- Average Trapezoidal Area Under the Curve (AUC)
Time frame: up to 740 min after start dosing for each treatment day
The mean AUC value was calculated as AUC (calculated using the trapezoidal method) divided by the length of the sampling period.
Vital Sign (Pulse Rate)- Average Trapezoidal Area Under the Curve (AUC)
Time frame: up to 740 min after start dosing for each treatment day
The mean AUC value was calculated as AUC (calculated using the trapezoidal method) divided by the length of the sampling period.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 22024920Saito T, Hasunuma T. Safety and tolerability of high-dose budesonide/formoterol via Turbuhaler(R) in Japanese patients with asthma: a randomized, double-blind, crossover, active comparator-controlled, phase III study. Clin Drug Investig. 2012 Jan 1;32(1):51-61. doi: 10.2165/11595440-000000000-00000.
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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 R&D Lund
2 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 Turbuhaler and Terbutaline Turbuhaler in people with Asthma, run by AstraZeneca at 2 sites in Japan.
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 4 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 29 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 2 sites in Japan. 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 29 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?
Adverse Events (time frame: 3 days). The study lists 6 primary outcomes in all. 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 NCT00837967, 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 29 Aug 2012.