AsthmaPhase 3SAKURANCT00839800

Study to Investigate the Efficacy of Symbicort® SMART.

A Phase 3 study testing Symbicort Turbuhaler and Terbutaline Turbuhaler in people with Asthma, run by AstraZeneca at 109 sites in 12 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The primary objective of this study is to compare the efficacy of Symbicort SMART (Symbicort Turbuhaler 160/4.5μg, one inhalation twice daily plus as needed) with Symbicort Turbuhaler 160/4.5μg, one inhalation twice daily plus terbutaline Turbuhaler 0.4 mg as needed, as asthma therapy Read more about this study

Who is it for?: Ages 16 years and older
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: 2,091 participants
Where: 109 sitesin 12 countries
Study dates: Feb 2009to Feb 2011
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 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Diagnosis of asthma according to the Global Initiative for Asthma guidelines (GINA) 2007 with a documented history of at least 6 months duration.
Reversible airway obstruction, defined as an increase in FEV1 ≥12% relative to baseline for all patients 15-30 minutes after inhalation of in total 2 x 0.4 mg terbutaline Turbuhaler
Prescribed use of inhaled glucocorticoid steroid (GCS) (any brand) for at least 12 weeks.

Who cannot join

Respiratory infection affecting the asthma, as judged by the investigator, within 4 weeks.
Intake of oral, rectal or parenteral GCS within 4 weeks and/or depot parenteral GCS within 12 weeks.

Trial locations and contacts

109 sites in 12 countries.

Country

City, postcode or hospital

109 sites in 12 countries

Japan45 sites

Research Site
Ako, Hyōgo
Research Site
Asahi, Chiba
Research Site
Asahikawa, Hokkaido
Research Site
Beppu, Oita Prefecture
Research Site
Chitose, Hokkaido
Research Site
Chūō, Tokyo
Research Site
Fukuoka, Fukuoka
Research Site
Fukuyama, Hiroshima
Research Site
Himeji, Hyōgo
Research Site
Hiroshima, Hiroshima
Research Site
Hitachi, Ibaraki
Research Site
Isesaki, Gunma
Research Site
Kagoshima, Kagoshima-ken
Research Site
Kawasaki, Kanagawa
Research Site
Kawasaki-shi, Kanagawa
Research Site
Kitakyushu, Fukuoka
Research Site
Kobe, Hyōgo
Research Site
Kochi, Kochi
Research Site
Kodaira, Tokyo
Research Site
Kokubunji, Tokyo
Research Site
Komaki, Aichi-ken
Research Site
Kurashiki, Okayama-ken
Research Site
Kyoto, Kyoto
Research Site
Machida, Tokyo
Research Site
Matsue, Shimane
Research Site
Matsuyama, Ehime
Research Site
Morioka, Iwate
Research Site
Nagaoka, Niigata
Research Site
Naka-gun, Ibaraki
Research Site
Nakano-ku, Tokyo
Research Site
Niigata, Niigata
Research Site
Ōita, Oita Prefecture
Research Site
Okayama, Okayama-ken
Research Site
Ōwa, Gunma
Research Site
Sakai, Osaka
Research Site
Sakaidechō, Kagawa-ken
Research Site
Sapporo, Hokkaido
Research Site
Sendai, Miyagi
Research Site
Seto, Aichi-ken
Research Site
tabashi City, Tokyo
Research Site
Tomakomai, Hokkaido
Research Site
Toshima-ku, Tokyo
Research Site
Utsunomiya, Tochigi
Research Site
Yanagawa, Fukuoka
Research Site
Yokohama, Kanagawa

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India10 sites

Research Site
Bangalore, Karnataka
Research Site
Coimabatore, Tamil Nadu
Research Site
Jaipur, Rajasthan
Research Site
Mangalore, Karnataka
Research Site
Mumbai, Maharashtra
Research Site
Mysore, Karnataka
Research Site
Nagpur, Maharashtra
Research Site
Noida
Research Site
Pune, Maharashtra
Research Site
Trivandrum, Kerala

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Argentina9 sites

Research Site
Buenos Aires, Argentina
Research Site
Capital Federal, Buenos Aires
Research Site
Ciudad de Buenos Aires
Research Site
Mar del Plata, Buenos Aires
Research Site
Monte Grande, Buenos Aires
Research Site
Quilmes, Buenos Aires
Research Site
Rosario, Santa Fe Province
Research Site
San Miguel de Tucumán, Tucumán Province
Research Site
Santa Fe, Santa Fe Province

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China8 sites

Research Site
Chongqing
Research Site
Guangzhou
Research Site
Hangzhou, Zhejiang
Research Site
Nanjing
Research Site
Qingdao
Research Site
Shanghai
Research Site
Shenyang, Liaoning
Research Site
Xi'an

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Brazil7 sites

Research Site
Belo Horizonte, Minas Gerais
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
Rio de Janeiro, Rio de Janeiro
Research Site
Santo André, São Paulo

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Hungary7 sites

Research Site
Budapest
Research Site
Cegléd
Research Site
Debrecen
Research Site
Deszk
Research Site
Gyula
Research Site
Nyíregyháza
Research Site
Százhalombatta

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Malaysia5 sites

Research Site
Batu Caves, Selangor
Research Site
George Town
Research Site
Kuala Lumpur
Research Site
Kuantan, Pahang
Research Site
Kubang Kerian, Kelantan

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Philippines5 sites

Research Site
Davao City, Philippines
Research Site
Iloilo City
Research Site
Lipa City, Batangas
Research Site
Manila
Research Site
Quezon City

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Thailand5 sites

Research Site
Bangkok, Thailand
Research Site
Bangkoknoi, Bangkok
Research Site
Hat Yai, Changwat Songkhla
Research Site
Khon Kaen
Research Site
Naimuang, Nakhonratchasima

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South Korea4 sites

Research Site
Bucheon-si
Research Site
Cheongju-si
Research Site
Seoul
Research Site
Suwon

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Costa Rica2 sites

Research Site
Barrio San Bosco, Provincia de San José
Research Site
Tres Ríos, Cartago Province

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Peru2 sites

Research Site
Lima, Lima Province
Research Site
Surco, Lima region

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About this study

Official title: A Comparison of Symbicort® SMART (160/4.5μg) and Symbicort® Turbuhaler 160/4.5 μg, Plus Terbutaline Turbuhaler 0.4 mg as Needed, for Treatment of Asthma - a 12-month, Randomized, Double-blind, Parallel Group, Active-controlled, Multinational Phase III Study in Asthmatic Patients From 16 Years

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
160/4.5 µg
Terbutaline TurbuhalerDrug
0.4 mg

Study groups in NCT00839800
Study group	Role	What they receive
1	Experimental	Symbicort Turbuhaler 160/4.5 µg one inhalation bid (twice daily) + Symbicort Turbuhaler 160/4.5 µg as needed Receives: Drug: Symbicort Turbuhaler
2	Active comparator	Symbicort Turbuhaler 160/4.5 µg one inhalation bid (twice daily) + terbutaline Turbuhaler 0.4 mg as needed Receives: Drug: Symbicort Turbuhaler; Drug: Terbutaline Turbuhaler

What is being measured

The primary outcome is the main question the study is designed to answer.

The Percentage of Participants Who Had Experienced Asthma Exacerbation(s) at the End of the Study
Asthma exacerbation was defined as deterioration in asthma leading to oral glucocorticosteroid [GCS] treatment, hospitalization, or emergency room [ER] treatment.
Measured: week 52

Secondary outcomes (12)

Number of Asthma Exacerbations
Asthma exacerbation was defined as deterioration in asthma leading to oral GCS treatment, hospitalization, or ER treatment. Number of asthma exacerbations during 52 weeks treatment was presented here.
Measured: up to 52 weeks
Morning Peak Expiratory Flow (PEF)
The mean value from a 52-week treatment period.
Measured: 52-week treatment period
Evening PEF
The mean value from a 52-week treatment period.
Measured: 2-week run-in period (14 - 18 days before randomization - week 0) and a 52-week treatment period
Forced Expiratory Volume in One Second (FEV1)
The mean value for Weeks 4, 12, 24, 36 and 52 was analysed.
Measured: 4, 12, 24, 36 and 52 weeks after randomization
Use of As-needed Medication
The mean value of total daily number of inhalations from the treatment period for use of as-needed medication (daytime, night-time).
Measured: 52-week treatment period
Asthma Symptom Score
The mean value from the treatment period for Total Asthma Symptom Score (total score: 0 is best - no asthma symptoms; 6 is worst).
Measured: 52-week treatment period
Nights With Awakening(s) Due to Asthma Symptoms
The mean value from the treatment period was presented here.
Measured: 52-week treatment period
The Percentage of Participants Who Had Experienced First Mild Asthma Exacerbations
Mild asthma exacerbation was defined as morning PEF ≥20% below baseline, daily as-needed medication use ≥2 inhalations above baseline, or a night with awakening due to asthma symptoms. The percentage of participants who had experienced mild asthma exacerbation(s) at the end of the study was presented here.
Measured: up to 52 weeks
Symptom-free Days (no Symptoms and no Awakenings)
A symptom-free day was defined as a day without daytime or night-time symptoms and without night-time awakenings due to asthma symptoms. The mean value was presented here.
Measured: 52-week treatment period
Percentage of As-needed-free Days
An as-needed-free day is defined as a night and day with no use of as-needed medication. The mean value from the treatment period was presented here.
Measured: 52-week treatment period
Percentage of Asthma-control Days (no Asthma Symptoms, no Awakenings, and no As-needed Use)
An asthma-control day was defined as a a night and day with no asthma symptoms, no awakenings due to asthma symptoms, and no as-needed medication use. The mean value from the treatment period was presented here.
Measured: 52-week treatment period
Asthma Control Questionnaire (ACQ)
The ACQ developed by Juniper and colleagues (Juniper et al 1999) was used without the FEV1 and Beta 2-agonist questions. The Asthma Control Questionnaire has 5 questions that are assessed on a 7-point scale from 0 to 6 where 0 represents good control and 6 represents poor control. The overall score is the mean of the five responses. At least 4 out of the 5 questions must have been answered to provide a value. The mean of the overall score for Weeks 4 to 52 was presented here.
Measured: 4, 12, 24, 36 and 52 weeks after randomization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2009Feb 2011

First posted10 Feb 2009 (estimated)
Study startFeb 2009
Primary completionFeb 2011
Study completionFeb 2011

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: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 2,091 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00839800
Sponsor's protocol ID: D589LC00001
Acronym: SAKURA
Status last verified: Nov 2012
First submitted: 4 Feb 2009
Last updated: 30 Nov 2012
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Zhang O, Minku LL, Gonem S. Detecting asthma exacerbations using daily home monitoring and machine learning. J Asthma. 2021 Nov;58(11):1518-1527. doi: 10.1080/02770903.2020.1802746. Epub 2020 Aug 14.
PubMed 32718193

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 30 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Comparison of Symbicort® SMART (160/4.5μg) and Symbicort® Turbuhaler 160/4.5 μg, Plus Terbutaline Turbuhaler 0.4 mg as Needed, for Treatment of Asthma - a 12-month, Randomized, Double-blind, Parallel Group, Active-controlled, Multinational Phase III Study in Asthmatic Patients From 16 Years
ClinicalTrials.gov ID: NCT00839800
Acronym / sponsor ID: SAKURA / D589LC00001
Conditions: Asthma
Keywords: Asthma, Symbicort Turbuhaler
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 2,091 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: Feb 2009
Primary completion: Feb 2011 (actual)
Study completion: Feb 2011 (actual)
First posted: 10 Feb 2009 (estimated)
Results: Posted 30 Nov 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
1	Experimental	Drug: Symbicort TurbuhalerSymbicort Turbuhaler 160/4.5 µg one inhalation bid (twice daily) + Symbicort Turbuhaler 160/4.5 µg as needed
2	Active comparator	Drug: Symbicort Turbuhaler, Drug: Terbutaline TurbuhalerSymbicort Turbuhaler 160/4.5 µg one inhalation bid (twice daily) + terbutaline Turbuhaler 0.4 mg as needed

Who may qualify

Ages: 16 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (3 listed)

Diagnosis of asthma according to the Global Initiative for Asthma guidelines (GINA) 2007 with a documented history of at least 6 months duration.
Reversible airway obstruction, defined as an increase in FEV1 ≥12% relative to baseline for all patients 15-30 minutes after inhalation of in total 2 x 0.4 mg terbutaline Turbuhaler
Prescribed use of inhaled glucocorticoid steroid (GCS) (any brand) for at least 12 weeks.

Key exclusion criteria (2 listed)

Respiratory infection affecting the asthma, as judged by the investigator, within 4 weeks.
Intake of oral, rectal or parenteral GCS within 4 weeks and/or depot parenteral GCS within 12 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 Turbuhaler160/4.5 µg	Drug	1, 2
Terbutaline Turbuhaler0.4 mg	Drug	2

Primary outcome

The Percentage of Participants Who Had Experienced Asthma Exacerbation(s) at the End of the Study
Time frame: week 52
Asthma exacerbation was defined as deterioration in asthma leading to oral glucocorticosteroid [GCS] treatment, hospitalization, or emergency room [ER] treatment.

12 secondary outcomes

Number of Asthma Exacerbations
Time frame: up to 52 weeks
Morning Peak Expiratory Flow (PEF)
Time frame: 52-week treatment period
Evening PEF
Time frame: 2-week run-in period (14 - 18 days before randomization - week 0) and a 52-week treatment period
Forced Expiratory Volume in One Second (FEV1)
Time frame: 4, 12, 24, 36 and 52 weeks after randomization
Use of As-needed Medication
Time frame: 52-week treatment period
Asthma Symptom Score
Time frame: 52-week treatment period
Nights With Awakening(s) Due to Asthma Symptoms
Time frame: 52-week treatment period
The Percentage of Participants Who Had Experienced First Mild Asthma Exacerbations
Time frame: up to 52 weeks
Symptom-free Days (no Symptoms and no Awakenings)
Time frame: 52-week treatment period
Percentage of As-needed-free Days
Time frame: 52-week treatment period
Percentage of Asthma-control Days (no Asthma Symptoms, no Awakenings, and no As-needed Use)
Time frame: 52-week treatment period
Asthma Control Questionnaire (ACQ)
Time frame: 4, 12, 24, 36 and 52 weeks after randomization

Results and safety

Results posted to the registry on 30 Nov 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Symbicort SMART	1,049	956
Symbicort+Terbutaline As Needed	1,042	932

Primary outcome: The Percentage of Participants Who Had Experienced Asthma Exacerbation(s) at the End of the Study

Time frame: week 52. Number. Unit: percentage of participants

Measure	Symbicort SMART n = 1049	Symbicort+Terbutaline As Needed n = 1042
Value	16	22

Population analysed: The analysis set for efficacy was based on the full analysis set (FAS) in line with the ICH E9 guideline.

12 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Symbicort SMART	41 of 1,049 (3.9%)	279 of 1,049 (26.6%)	Not reported
Symbicort+Terbutaline As Needed	74 of 1,042 (7.1%)	293 of 1,042 (28.1%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 32718193Zhang O, Minku LL, Gonem S. Detecting asthma exacerbations using daily home monitoring and machine learning. J Asthma. 2021 Nov;58(11):1518-1527. doi: 10.1080/02770903.2020.1802746. Epub 2020 Aug 14.

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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

Tito Atienza, M.D. principal investigator

Mary Mediatrix Medical Center, Lipa City, Philippines

109 sites in 12 countries: 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 109 sites in 12 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 2 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 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 109 sites in Japan, India, Argentina, China, Brazil and 7 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 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 30 Nov 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?

The Percentage of Participants Who Had Experienced Asthma Exacerbation(s) at the End of the Study (time frame: week 52). 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 NCT00839800, 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 Nov 2012.