AsthmaPhase 3NCT00252785
Efficacy & Safety of Symbicort® TURBUHALER® 160/4.5 µg Twice Daily & Pulmicort® TURBUHALER® 200 µg Twice Daily + Theolong® Tablet 200 mg Twice Daily in Japanese Asthmatic Patients
A Phase 3 study testing Budesonide/Formoterol, Budesonide and Theophylline in people with Asthma, run by AstraZeneca at 43 sites in Japan.
Trial summary
The primary objective of this study is to confirm the efficacy (superiority) of Symbicort® Turbuhaler® 160/4.5 µg twice daily for 8 weeks in comparison to Pulmicort® Turbuhaler® 200 µg twice daily + Theolong® tablet 200 mg twice daily. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Asthma
- What is being tested?
- Budesonide/Formoterol, Budesonide and Theophylline
- How many people
- 340 participants
- Where
- 43 sitesJapan
- Study dates
- Oct 2005to Nov 2006
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 with a documented history of at least 6 months duration prior to Visit 1
- Prescribed daily use of an IGCS for >=12 weeks prior to Visit 1. The dose of IGCS must be 400 to 800 µg/day of Pulmicort® Turbuhaler® or corresponding dose of IGCS. The prescribed dose of IGCS should be constant for at least 4 weeks prior to Visit 1
- Prescribed daily use of sustained release theophylline for at least 8 weeks prior to Visit 1, or confirmed steady-state blood theophylline concentrations within the effective range (5-15 µg/mL) during 8 weeks prior to Visit 1. The prescribed dose of theophylline should be constant (400 mg/day) for at least 4 weeks prior to Visit 1
Who cannot join
- Any significant disease or disorder that may jeopardize the safety of the patient
- Respiratory infection, judged by the investigator(s) as an infection affecting the asthma, within 4 weeks prior to Visit 1
- Treatment with oral, parenteral or rectal GCS within 4 weeks prior to Visit 1
- Additional inclusion and exclusion criteria will be evaluated by the Investigator
Trial locations and contacts
43 sites in 1 country.
43 sites in 1 country
Japan43 sites
Research Site
Arakawa City, Tokyo
Research Site
Asahi, Chiba
Research Site
Beppu, Ohita
Research Site
Chitose, Hokkaido
Research Site
Chiyoda City, Tokyo
Research Site
Gifu, Gifu
Research Site
Hiroshima, Hiroshima
Research Site
Isesaki, Gunma
Research Site
Kagoshima, Kagoshima-ken
Research Site
Kishiwada, Osaka
Research Site
Kitahiroshima, Hokkaido
Research Site
Kodaira, Tokyo
Research Site
Komaki, Aichi-ken
Research Site
Koshigaya, Saitama
Research Site
Kyoto, Kyoto
Research Site
Maebashi, Gunma
Research Site
Minamisaitama, Saitama
Research Site
Miyaodai, Fukuoka
Research Site
Morioka, Iwate
Research Site
Nakano-ku, Tokyo
Research Site
Noda, Chiba
Research Site
Obihiro, Hokkaido
Research Site
Ōita, Oita Prefecture
Research Site
Okayama, Okayama-ken
Research Site
Osaka, Osaka
Research Site
Oskasayama, Osaka
Research Site
Ōta, Gunma
Research Site
Ōta-ku, Tokyo
Research Site
Ōwa, Gunma
Research Site
Sapporo, Hokkaido
Research Site
Sendai, Miyagi
Research Site
Seto, Aichi-ken
Research Site
Shinagawa-ku, Tokyo
Research Site
Sumida City, Tokyo
Research Site
tabashi City, Tokyo
Research Site
Takamatsu, Kagawa-ken
Research Site
Takatsuiki, Osaka
Research Site
Tochigi
Research Site
Tomakomai, Hokkaido
Research Site
Touon, Ehime
Research Site
Toyama, Toyama
Research Site
Tsukubo, Okayama-ken
Research Site
Ube, Yamaguchi
About this study
Official title: An 8-week, Randomised, Double Blind, Parallel-group, Multi-centre, Phase III Study Comparing the Efficacy and Safety of Symbicort® Turbuhaler® 160/4.5 µg Twice Daily and Pulmicort® Turbuhaler® 200 µg Twice Daily + Theolong® Tablet 200 mg Twice Daily in Japanese Patients With Asthma
The primary objective of this study is to confirm the efficacy (superiority) of Symbicort® Turbuhaler® 160/4.5 µg twice daily for 8 weeks in comparison to Pulmicort® Turbuhaler® 200 µg twice daily + Theolong® tablet 200 mg twice daily.
- Conditions
- Asthma
- Being tested
- Budesonide/Formoterol, Budesonide, Theophylline
- Keywords
- Asthma
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Budesonide/FormoterolDrug
Also called Symbicort
BudesonideDrug
TheophyllineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Morning peak expiratory flow (mPEF)
Secondary outcomes (7)
Patient reported outcomes regarding disease status (incl. evening PEF), collected via diaries
Forced expiratory volume in one second (FEV1)
Safety:
Adverse events (nature, incidence and severity)
Haematology, clinical chemistry and urinalysis
12-lead ECGs, blood pressure, pulse rate
- all variables assessed over the 8 week treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2005 (estimated)
- Study startOct 2005
- Study completionNov 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Double blind
- Enrolment
- 340 participants
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- AstraZeneca Symbicort Medical Science Director, MD, Study director, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00252785
- Sponsor's protocol ID
- D5890C00010
- Status last verified
- Jan 2011
- First submitted
- 11 Nov 2005
- Last updated
- 24 Jan 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An 8-week, Randomised, Double Blind, Parallel-group, Multi-centre, Phase III Study Comparing the Efficacy and Safety of Symbicort® Turbuhaler® 160/4.5 µg Twice Daily and Pulmicort® Turbuhaler® 200 µg Twice Daily + Theolong® Tablet 200 mg Twice Daily in Japanese Patients With Asthma
- ClinicalTrials.gov ID
- NCT00252785
- Acronym / sponsor ID
- D5890C00010
- Conditions
- Asthma
- Keywords
- Asthma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 340 participants
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Oct 2005
- Study completion
- Nov 2006 (actual)
- First posted
- 15 Nov 2005 (estimated)
- Results
- Not posted in the source record
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 this study is to confirm the efficacy (superiority) of Symbicort® Turbuhaler® 160/4.5 µg twice daily for 8 weeks in comparison to Pulmicort® Turbuhaler® 200 µg twice daily + Theolong® tablet 200 mg twice daily.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
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 with a documented history of at least 6 months duration prior to Visit 1
- Prescribed daily use of an IGCS for >=12 weeks prior to Visit 1. The dose of IGCS must be 400 to 800 µg/day of Pulmicort® Turbuhaler® or corresponding dose of IGCS. The prescribed dose of IGCS should be constant for at least 4 weeks prior to Visit 1
- Prescribed daily use of sustained release theophylline for at least 8 weeks prior to Visit 1, or confirmed steady-state blood theophylline concentrations within the effective range (5-15 µg/mL) during 8 weeks prior to Visit 1. The prescribed dose of theophylline should be constant (400 mg/day) for at least 4 weeks prior to Visit 1
Key exclusion criteria (4 listed)
- Any significant disease or disorder that may jeopardize the safety of the patient
- Respiratory infection, judged by the investigator(s) as an infection affecting the asthma, within 4 weeks prior to Visit 1
- Treatment with oral, parenteral or rectal GCS within 4 weeks prior to Visit 1
- Additional inclusion and exclusion criteria will be evaluated by the Investigator
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 |
|---|---|---|
| Budesonide/FormoterolAlso: Symbicort | Drug | – |
| Budesonide | Drug | – |
| Theophylline | Drug | – |
Primary outcome
Morning peak expiratory flow (mPEF)
7 secondary outcomes
Patient reported outcomes regarding disease status (incl. evening PEF), collected via diaries
Forced expiratory volume in one second (FEV1)
Safety:
Adverse events (nature, incidence and severity)
Haematology, clinical chemistry and urinalysis
12-lead ECGs, blood pressure, pulse rate
- all variables assessed over the 8 week treatment period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2011.
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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.
AstraZeneca Symbicort Medical Science Director, MD study director
AstraZeneca
43 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 Budesonide/Formoterol, Budesonide and Theophylline in people with Asthma, run by AstraZeneca at 43 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 24 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 43 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 (mPEF). 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 24 Jan 2011.