AsthmaPhase 3NCT00288379
SMILDA - Symbicort®Turbuhaler® Allergan Challenge Study in Allergic Patients With Mild Asthma
A Phase 3 study testing formoterol and budesonide/formoterol in people with Asthma, run by AstraZeneca at 1 site in Sweden.
Trial summary
To compare the effects of formoterol alone (Oxis® TurbuhalerÒ) and the fixed combination of formoterol and budesonide (Symbicort® TurbuhalerÒ) on airway responsiveness as a marker of inflammation, induced by repeated low-dose allergen challenge in allergic patients with mild asthma Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Asthma
- What is being tested?
- formoterol and budesonide/formoterol
- How many people
- 16 participants
- Where
- 1 siteSweden
- Study dates
- Oct 2004to 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 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- A diagnosed history of asthma for at least 6 months
- Mild and stable asthma, only using β2-agonists as needed for the last 4 weeks.
- FEV1 >70% of predicted normal value (post-bronchodilator value).
- Skin prick test positive to pollen, animal dander or house dust mite.
Who cannot join
- Any significant respiratory disease, other than asthma.
- Upper or lower respiratory tract infection within 4 weeks before inclusion.
- Use of:
- inhaled glucocorticosteroid treatment for the last 8 weeks prior to inclusion or ever used oral glucocorticoid treatment for asthma.
- inhaled long-acting or oral b2-agonists, anticholinergic bronchodilators, cromones, antihistamines, theophyllines and anti-leukotrienes within 2 weeks of screening.
- regular NSAIDs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparative, Placebo-controlled, Double Blind, Double Dummy, Cross-over, Single Centre, Phase IIIb Study Between Formoterol Alone (Oxis® Turbuhaler® 4.5 µg) and the Fixed Combination of Formoterol and Budesonide (Symbicort® Turbuhaler®160/4.5 µg) on Airway Responsiveness and Airway Inflammation Induced by Repeated Low-dose Allergen Challenge in Allergic Patients With Mild Asthma
To compare the effects of formoterol alone (Oxis® TurbuhalerÒ) and the fixed combination of formoterol and budesonide (Symbicort® TurbuhalerÒ) on airway responsiveness as a marker of inflammation, induced by repeated low-dose allergen challenge in allergic patients with mild asthma
- Conditions
- Asthma
- Being tested
- formoterol, budesonide/formoterol
- Keywords
- Asthma, allergen challenge, airway responsiveness, airway inflammation, Symbicort®
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
formoterolDrug
budesonide/formoterolDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
PD20 methacholine (measured as the change using the measurement before and after each treatment period).
Secondary outcomes (6)
eNO (ppb).
Forced Expiratory Volume in one second (FEV1 ) - Induced sputum:
Total and differential blood cell count
Different Biomarkers
Safety endpoints will be incidence of Serious Adverse Events (SAEs)
Discontinuation due to Adverse Events (DAEs).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2006 (estimated)
- Study startOct 2004
- Study completionMay 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
- Crossover
- Masking
- Double blind
- Enrolment
- 16 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
- NCT00288379
- Sponsor's protocol ID
- D5890L00007
- Other IDs
- EudraCT No 2004-000211-26
- Status last verified
- Jan 2011
- First submitted
- 7 Feb 2006
- 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
- A Comparative, Placebo-controlled, Double Blind, Double Dummy, Cross-over, Single Centre, Phase IIIb Study Between Formoterol Alone (Oxis® Turbuhaler® 4.5 µg) and the Fixed Combination of Formoterol and Budesonide (Symbicort® Turbuhaler®160/4.5 µg) on Airway Responsiveness and Airway Inflammation Induced by Repeated Low-dose Allergen Challenge in Allergic Patients With Mild Asthma
- ClinicalTrials.gov ID
- NCT00288379
- Acronym / sponsor ID
- D5890L00007
- Conditions
- Asthma
- Keywords
- Asthma, allergen challenge, airway responsiveness, airway inflammation, Symbicort®
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Oct 2004
- Study completion
- May 2006 (actual)
- First posted
- 8 Feb 2006 (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.
To compare the effects of formoterol alone (Oxis® TurbuhalerÒ) and the fixed combination of formoterol and budesonide (Symbicort® TurbuhalerÒ) on airway responsiveness as a marker of inflammation, induced by repeated low-dose allergen challenge in allergic patients with mild asthma
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- A diagnosed history of asthma for at least 6 months
- Mild and stable asthma, only using β2-agonists as needed for the last 4 weeks.
- FEV1 >70% of predicted normal value (post-bronchodilator value).
- Skin prick test positive to pollen, animal dander or house dust mite.
Key exclusion criteria (6 listed)
- Any significant respiratory disease, other than asthma.
- Upper or lower respiratory tract infection within 4 weeks before inclusion.
- Use of:
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 |
|---|---|---|
| formoterol | Drug | – |
| budesonide/formoterol | Drug | – |
Primary outcome
PD20 methacholine (measured as the change using the measurement before and after each treatment period).
6 secondary outcomes
eNO (ppb).
Forced Expiratory Volume in one second (FEV1 ) - Induced sputum:
Total and differential blood cell count
Different Biomarkers
Safety endpoints will be incidence of Serious Adverse Events (SAEs)
Discontinuation due to Adverse Events (DAEs).
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing formoterol and budesonide/formoterol in people with Asthma, run by AstraZeneca at 1 site in Sweden.
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 4 inclusion and 6 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 1 site in Sweden. 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?
PD20 methacholine (measured as the change using the measurement before and after each treatment period).. 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.