AsthmaPhase 3NCT00242775
Comparison of the Efficacy/Safety of Symbicort® Turbuhaler®,Seretide™ Diskus™ 50/500 µg & Terbutaline Turbuhaler® 0.4 mg
A Phase 3 study testing Budesonide/formoterol Turbuhaler and Salmeterol/fluticasone Diskus in people with Asthma, run by AstraZeneca at 143 sites in 17 countries.
Trial summary
The purpose of this study is to compare the efficacy and safety of a variable dose of Symbicort with a high fixed maintenance dose of another asthma medication, Seretide, in the treatment of asthma. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Asthma
- What is being tested?
- Budesonide/formoterol Turbuhaler and Salmeterol/fluticasone Diskus
- How many people
- 2,100 participants
- Where
- 143 sitesin 17 countries
- Study dates
- May 2005to May 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Diagnosed with asthma since at least 6 months prior to first visit
- Prescribed daily use of glucocorticosteroids for at least 3 months prior to first visit
- At least one asthma exacerbation more than one but less than twelve months prior to first visit
Who cannot join
- Respiratory infection affecting asthma within 30 days before first visit
- Use of oral, rectal, or parenteral glucocorticosteroids for within 30 days before first visit
- Any significant disease or disorder that may jeopardize the safety of the patient
- Additional inclusion and exclusion criteria will be evaluated by the Investigator.
Trial locations and contacts
143 sites in 17 countries.
143 sites in 17 countries
France24 sites
Research Site
Angers
Research Site
Bernay
Research Site
Béthune
Research Site
Chamalières
Research Site
Férolles-Attilly
Research Site
Grasse
Research Site
Hénin-Beaumont
Research Site
La Rochelle
Research Site
Laon
Research Site
Le Havre
Research Site
Lille
Research Site
Lorient
Research Site
Marseille
Research Site
Montereau-Fault-Yonne
Research Site
Montpellier
Research Site
Nantes
Research Site
Nîmes
Research Site
Paris
Research Site
Saint-Denis
Research Site
Saint-Laurent-du-Var
Research Site
Sélestat
Research Site
Toulouse
Research Site
Villebon-sur-Yvette
Research Site
Villejuif
Germany21 sites
Research Site
Bad Segeberg, Schleswig-Holstein
Research Site
Berlin, State of Berlin
Research Site
Bonn
Research Site
Cottbus, Brandenburg
Research Site
Düsseldorf, North Rhine-Westphalia
Research Site
Düsseldorf
Research Site
Erfurt
Research Site
Frankfurt am Main, Hesse
Research Site
Geesthacht
Research Site
Großhansdorf
Research Site
Hagen
Research Site
Hamburg, Free and Hanseatic City of Hamburg
Research Site
Jena-Maua, Thuringia
Research Site
Kassel
Research Site
Koblenz
Research Site
Lübeck
Research Site
Marburg
Research Site
Münster, North Rhine-Westphalia
Research Site
Neuruppin
Research Site
Sonneberg
Research Site
Witten
Canada15 sites
Research Site
Edmonton, Alberta
Research Site
Hamilton, Ontario
Research Site
London, Ontario
Research Site
Mississauga, Ontario
Research Site
Montreal, Quebec
Research Site
Mount Pearl, Newfoundland and Labrador
Research Site
North York, Ontario
Research Site
Ottawa, Ontario
Research Site
Québec, Quebec
Research Site
Saint-Léonard, Quebec
Research Site
Saskatoon, Saskatchewan
Research Site
Ste-Foy, Quebec
Research Site
Toronto, Ontario
Research Site
Trois-Rivières, Quebec
Research Site
Winnipeg, Manitoba
South Africa15 sites
Research Site
Bellville
Research Site
Bloemfontein
Research Site
Bryanston, Gauteng
Research Site
Cape Town
Research Site
Durban
Research Site
eMkhomazi
Research Site
Florida Park, Gauteng
Research Site
Hillcrest, Pretoria
Research Site
Johannesburg
Research Site
Lenasia, Gauteng
Research Site
Linksfield, Gauteng
Research Site
Lyttelton Manor
Research Site
Pretoria
Research Site
Sandton, Gauteng
Research Site
Witbank, Gauteng
Australia14 sites
Research Site
Ashford, South Australia
Research Site
Bankstown, New South Wales
Research Site
Box Hill, Victoria
Research Site
Bundaberg, Queensland
Research Site
Carina Heights, Queensland
Research Site
Mackay, Queensland
Research Site
Malvern, Victoria
Research Site
Nedlands, Western Australia
Research Site
Prahran, Victoria
Research Site
Rosebud, Victoria
Research Site
Sydney, New South Wales
Research Site
Toorak Gardens, South Australia
Research Site
Westmead, New South Wales
Research Site
Woodville South, South Australia
Spain11 sites
Research Site
Barcelona, Barcelona
Research Site
El Palmar, Murcia
Research Site
Granada, Granada
Research Site
Jaén, Jaén
Research Site
Madrid, Madrid
Research Site
San Sebastián, Guipuzcoa
Research Site
Santander, Cantabria
Research Site
Seville, Sevilla
Research Site
Seville
Research Site
Vitoria-Gasteiz, Vitoria
Research Site
Zaragoza, Zaragoza
Brazil8 sites
Research Site
Curitiba
Research Site
Florianópolis, Santa Catarina
Research Site
Juiz de Fora, Minas Gerais
Research Site
Recife, Pernambuco
Research Site
Rio de Janeiro, Rio de Janeiro
Research Site
Salvador, Estado de Bahia
Research Site
São Paulo, São Paulo
Research Site
São Paulo
Argentina7 sites
Research Site
Buenos Aires
Research Site
Córdoba, Córdoba Province
Research Site
Mar del Plata, Buenos Aires
Research Site
Monte Grande, Buenos Aires
Research Site
San Miguel de Tucumán, Tucumán Province
Research Site
San Miguel de Tucumán
Research Site
Santa Fe, Santa Fe Province
China6 sites
Research Site
Beijing
Research Site
Guangzhou
Research Site
Nanjin
Research Site
Shanghai
Research Site
Shanxi
Research Site
Shenyang
Indonesia6 sites
Research Site
Bandung
Research Site
Jakarta
Research Site
Jakarta Timur, Jakarta - Indonesia
Research Site
Jakarta Timur
Research Site
Semarang, Central Java
Research Site
Solo
India4 sites
Research Site
Coimbatore
Research Site
Hyderbad
Research Site
Mumbai
Research Site
Noida
Mexico3 sites
Research Site
México
Research Site
Villahermosa, Tabasco
Research Site
Zapopan, Jalisco
Philippines3 sites
Research Site
Cebu City
Research Site
Iloilo City
Research Site
Quezon City
About this study
Official title: Efficacy and Safety of Symbicort ®Turbuhaler® 160/4.5 µg/Inhalation, Two Inhalations Twice Daily Plus As-needed Compared With Seretide™ Diskus™ 50/500 µg/Inhalation, One Inhalation Twice Daily Plus Terbutaline Turbuhaler 0.4 mg/Inhalation As-needed - a 6-month, Randomised, Double-blind, Parallel-group, Active Controlled, Multinational Phase IIIB Study in Adult and Adolescent Patients With Persistent Asthma (AHEAD).
The purpose of this study is to compare the efficacy and safety of a variable dose of Symbicort with a high fixed maintenance dose of another asthma medication, Seretide, in the treatment of asthma.
- Conditions
- Asthma
- Being tested
- Budesonide/formoterol Turbuhaler, Salmeterol/fluticasone Diskus
- 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/formoterol TurbuhalerDrug
Also called Symbicort
Salmeterol/fluticasone DiskusDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to first severe asthma exacerbation
Secondary outcomes (7)
Number of severe asthma exacerbations
Mild asthma exacerbations
FEV1
Patient-reported outcomes regarding disease status (inlc. PEF), collected via questionnaires and diaries
Healthcare utilization
Safety (adverse events)
- all variables assessed over the 6 months treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2005 (estimated)
- Study startMay 2005
- Study completionMay 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Double blind
- Enrolment
- 2,100 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
- NCT00242775
- Sponsor's protocol ID
- D5890C00002
- Other IDs
- EurodraCT No. 2004-004905-11, AHEAD
- Status last verified
- Jan 2011
- First submitted
- 20 Oct 2005
- Last updated
- 24 Jan 2011
- Results posted
- No
Publications
Lin JT, Chen P, Zhou X, Sun TY, Xie CM, Xiu QY, Yao WZ, Yang L, Yin KS, Zhang YM. Budesonide/formoterol maintenance and reliever therapy in Chinese patients with asthma. Chin Med J (Engl). 2012 Sep;125(17):2994-3001.
PubMed 22932169Bousquet J, Boulet LP, Peters MJ, Magnussen H, Quiralte J, Martinez-Aguilar NE, Carlsheimer A. Budesonide/formoterol for maintenance and relief in uncontrolled asthma vs. high-dose salmeterol/fluticasone. Respir Med. 2007 Dec;101(12):2437-46. doi: 10.1016/j.rmed.2007.07.014. Epub 2007 Oct 1.
PubMed 17905575
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
- Efficacy and Safety of Symbicort ®Turbuhaler® 160/4.5 µg/Inhalation, Two Inhalations Twice Daily Plus As-needed Compared With Seretide™ Diskus™ 50/500 µg/Inhalation, One Inhalation Twice Daily Plus Terbutaline Turbuhaler 0.4 mg/Inhalation As-needed - a 6-month, Randomised, Double-blind, Parallel-group, Active Controlled, Multinational Phase IIIB Study in Adult and Adolescent Patients With Persistent Asthma (AHEAD).
- ClinicalTrials.gov ID
- NCT00242775
- Acronym / sponsor ID
- D5890C00002
- Conditions
- Asthma
- Keywords
- Asthma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,100 participants
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- May 2005
- Study completion
- May 2006 (actual)
- First posted
- 21 Oct 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 purpose of this study is to compare the efficacy and safety of a variable dose of Symbicort with a high fixed maintenance dose of another asthma medication, Seretide, in the treatment of asthma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
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)
- Diagnosed with asthma since at least 6 months prior to first visit
- Prescribed daily use of glucocorticosteroids for at least 3 months prior to first visit
- At least one asthma exacerbation more than one but less than twelve months prior to first visit
Key exclusion criteria (4 listed)
- Respiratory infection affecting asthma within 30 days before first visit
- Use of oral, rectal, or parenteral glucocorticosteroids for within 30 days before first visit
- Any significant disease or disorder that may jeopardize the safety of the patient
- 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/formoterol TurbuhalerAlso: Symbicort | Drug | – |
| Salmeterol/fluticasone Diskus | Drug | – |
Primary outcome
Time to first severe asthma exacerbation
7 secondary outcomes
Number of severe asthma exacerbations
Mild asthma exacerbations
FEV1
Patient-reported outcomes regarding disease status (inlc. PEF), collected via questionnaires and diaries
Healthcare utilization
Safety (adverse events)
- all variables assessed over the 6 months 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.
- Derived from this study: PubMed 22932169Lin JT, Chen P, Zhou X, Sun TY, Xie CM, Xiu QY, Yao WZ, Yang L, Yin KS, Zhang YM. Budesonide/formoterol maintenance and reliever therapy in Chinese patients with asthma. Chin Med J (Engl). 2012 Sep;125(17):2994-3001.
- Derived from this study: PubMed 17905575Bousquet J, Boulet LP, Peters MJ, Magnussen H, Quiralte J, Martinez-Aguilar NE, Carlsheimer A. Budesonide/formoterol for maintenance and relief in uncontrolled asthma vs. high-dose salmeterol/fluticasone. Respir Med. 2007 Dec;101(12):2437-46. doi: 10.1016/j.rmed.2007.07.014. Epub 2007 Oct 1.
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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
143 sites in 17 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Budesonide/formoterol Turbuhaler and Salmeterol/fluticasone Diskus in people with Asthma, run by AstraZeneca at 143 sites in 17 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 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 143 sites in France, Germany, Canada, South Africa, Australia and 12 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?
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?
Time to first severe asthma exacerbation. 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 NCT00242775, which also lists 2 linked publications.
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.