AsthmaPhase 4STARTNCT00641914
Inhaled Steroid Treatment as Regular Therapy in Early Asthma
A Phase 4 study testing budesonide in people with Asthma, run by AstraZeneca.
Trial summary
A study of the effect of the early treatment with Pulmicort of newly diagnosed asthma. Patients will receive either Pulmicort or a non-active treatment for three years. Neither patients or investigators will be aware of the treatment received. Read more about this study
- Who is it for?
- Ages 6 to 60 years
- Conditions the study is for
- Asthma
- What is being tested?
- budesonide
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 6,800 participants
- Where
- No sites listed yet
- Study dates
- Oct 1996to Feb 2003
- Phase
- Phase 4
- 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 6 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Male or female patients aged between 6 and 60 years
- diagnosed with asthma within 2 years of starting the study
- Ability to use a Turbuhaler
Who cannot join
- Symptoms indicating asthma (e.g. wheezing) for more than two years prior to starting the study
- A history of the use of treatments like Pulmicort for more than 30 days per year in the two years before starting the study
- Regular daily treatment for asthma for more than two years before starting the study
About this study
Official title: Inhaled Steroid Treatment As Regular Therapy in Early Asthma. A Study on the Effect of Early Intervention With Long-Term Inhaled Budesonide (Pulmicort Turbuhaler ® ) in Newly Diagnosed Asthma.
A study of the effect of the early treatment with Pulmicort of newly diagnosed asthma. Patients will receive either Pulmicort or a non-active treatment for three years. Neither patients or investigators will be aware of the treatment received. After three years of treatment all patients will receive Pulmicort for 2 further years.
- Conditions
- Asthma
- Being tested
- budesonide, Placebo
- Keywords
- Asthma, Pulmicort, budesonide
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
budesonideDrug
Also called Pulmicort
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: budesonide |
| 2 | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severe asthma related events (SARE) (part A); post-bronchodilator FEV1 % of predicted normal (part B)
Measured: At week 6 and12, and every 3 months thereafter
Secondary outcomes (3)
Pre-bronchodilator FEV1 % of predicted normal
Measured: At week 6 and12, and every 3 months thereafter
HE: Asthma related events and health care utilisation, and symptom free days (SFD)
Measured: At week 6 and12, and every 3 months thereafter
Post-bronchodilator FVC % of predicted
Measured: At week 6 and12, and every 3 months thereafter
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2008 (estimated)
- Study startOct 1996
- Primary completionFeb 2003
- Study completionFeb 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 6,800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Romain Pauwels, Study chair, Steering Committee ChairmanWilliam Busse, Study chair, Steering Committee Chairman
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00641914
- Sponsor's protocol ID
- SD-004-0111
- Other IDs
- D5254C00111
- Acronym
- START
- Status last verified
- Mar 2009
- First submitted
- 18 Mar 2008
- Last updated
- 25 Mar 2009
- Results posted
- No
Publications
O'Byrne PM, Pedersen S, Lamm CJ, Tan WC, Busse WW; START Investigators Group. Severe exacerbations and decline in lung function in asthma. Am J Respir Crit Care Med. 2009 Jan 1;179(1):19-24. doi: 10.1164/rccm.200807-1126OC. Epub 2008 Oct 31.
PubMed 18990678
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inhaled Steroid Treatment As Regular Therapy in Early Asthma. A Study on the Effect of Early Intervention With Long-Term Inhaled Budesonide (Pulmicort Turbuhaler ® ) in Newly Diagnosed Asthma.
- ClinicalTrials.gov ID
- NCT00641914
- Acronym / sponsor ID
- START / SD-004-0111
- Conditions
- Asthma
- Keywords
- Asthma, Pulmicort, budesonide
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6,800 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Oct 1996
- Primary completion
- Feb 2003 (actual)
- Study completion
- Feb 2003 (actual)
- First posted
- 24 Mar 2008 (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.
A study of the effect of the early treatment with Pulmicort of newly diagnosed asthma. Patients will receive either Pulmicort or a non-active treatment for three years. Neither patients or investigators will be aware of the treatment received. After three years of treatment all patients will receive Pulmicort for 2 further years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: budesonide |
| 2 | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 6 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Male or female patients aged between 6 and 60 years
- diagnosed with asthma within 2 years of starting the study
- Ability to use a Turbuhaler
Key exclusion criteria (3 listed)
- Symptoms indicating asthma (e.g. wheezing) for more than two years prior to starting the study
- A history of the use of treatments like Pulmicort for more than 30 days per year in the two years before starting the study
- Regular daily treatment for asthma for more than two years before starting the study
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 |
|---|---|---|
| budesonideAlso: Pulmicort | Drug | 1 |
| Placebo | Drug | 2 |
Primary outcome
Severe asthma related events (SARE) (part A); post-bronchodilator FEV1 % of predicted normal (part B)
Time frame: At week 6 and12, and every 3 months thereafter
3 secondary outcomes
Pre-bronchodilator FEV1 % of predicted normal
Time frame: At week 6 and12, and every 3 months thereafter
HE: Asthma related events and health care utilisation, and symptom free days (SFD)
Time frame: At week 6 and12, and every 3 months thereafter
Post-bronchodilator FVC % of predicted
Time frame: At week 6 and12, and every 3 months thereafter
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 25 Mar 2009.
- Derived from this study: PubMed 18990678O'Byrne PM, Pedersen S, Lamm CJ, Tan WC, Busse WW; START Investigators Group. Severe exacerbations and decline in lung function in asthma. Am J Respir Crit Care Med. 2009 Jan 1;179(1):19-24. doi: 10.1164/rccm.200807-1126OC. Epub 2008 Oct 31.
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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.
Romain Pauwels study chair
Steering Committee Chairman
William Busse study chair
Steering Committee Chairman
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing budesonide in people with Asthma, run by AstraZeneca.
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 3 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 25 Mar 2009. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Severe asthma related events (SARE) (part A); post-bronchodilator FEV1 % of predicted normal (part B) (time frame: At week 6 and12, and every 3 months thereafter). 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 NCT00641914, 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 25 Mar 2009.