AsthmaPhase 3NCT00642122
Adults With Moderate to Severe Asthma
A Phase 3 study testing Budesonide in people with Asthma, run by AstraZeneca.
Trial summary
A study to compare the safety and effectiveness of 5 different ways of taking Pulmicort when given to asthma patients aged 12 years and above. 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
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 900 participants
- Where
- No sites listed yet
- Study dates
- Apr 2003to Dec 2004
- 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
- Male or female aged 12 or over who have asthma
- Ability to properly use an electronic diary
- Able and willing to nebulize for up to 20 minutes every morning and evening
Who cannot join
- Hospitalised at least one once or required emergency treatment due to asthma in the previous 6 months
- Planned hospitalisation during the study
- pregnant women or women planning to become pregnant
About this study
Official title: A Randomized, Blinded, Multicenter, Parallel Study Comparing the Efficacy and Safety of Pulmicort Respules at 0.5mg QD, 1.0mg QD, 1.0mg Bid, 2.0mg Bid and Pulmicort Turbuhaler at 4.00mcg Bid on Adolescents (12 Yrs of Age and Older) With Adults With Moderate to Severe Asthma.
A study to compare the safety and effectiveness of 5 different ways of taking Pulmicort when given to asthma patients aged 12 years and above.
- Conditions
- Asthma
- Being tested
- Budesonide
- Keywords
- Asthma, Pulmicort, budesonide, respules, turbuhaler
- 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 RESPULES
0.5mg once daily
BudesonideDrug
Also called Pulmicort RESPULES
1mg once daily
BudesonideDrug
Also called Pulmicort RESPULES
1mg twice daily
BudesonideDrug
Also called Pulmicort RESPULES
2mg once daily
BudesonideDrug
Also called Pulmicort TURBUHALER
4.00mcg twice daily
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Pulmicort RESPULES Receives: Drug: Budesonide |
| 2 | Experimental | Pulmicort TURBUHALER Receives: Drug: Budesonide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Forced Expiratory Volume in 1 second in patients allocated treatment with Pulmicort REPSULES at 0.5mg and 2.0mg.
Measured: Day -14, 1, and every 28 days thereafter
Secondary outcomes (3)
Percentage of symptom free days
Measured: Day -14, 1, and every 28 days thereafter
Percentage of symptom free nights
Measured: Day -14, 1, and every 28 days thereafter
Percentage of symptom free 24-hours
Measured: Day -14, 1, and every 28 days 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 startApr 2003
- Primary completionDec 2004
- Study completionDec 2004
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
- Single blind
- Enrolment
- 900 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Bertil Andersson, Study director, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00642122
- Sponsor's protocol ID
- SD-004-0764
- Other IDs
- D5257L00012
- Status last verified
- Jan 2011
- First submitted
- 18 Mar 2008
- Last updated
- 24 Jan 2011
- Results posted
- No
- Data monitoring committee
- 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 Randomized, Blinded, Multicenter, Parallel Study Comparing the Efficacy and Safety of Pulmicort Respules at 0.5mg QD, 1.0mg QD, 1.0mg Bid, 2.0mg Bid and Pulmicort Turbuhaler at 4.00mcg Bid on Adolescents (12 Yrs of Age and Older) With Adults With Moderate to Severe Asthma.
- ClinicalTrials.gov ID
- NCT00642122
- Acronym / sponsor ID
- SD-004-0764
- Conditions
- Asthma
- Keywords
- Asthma, Pulmicort, budesonide, respules, turbuhaler
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 900 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Apr 2003
- Primary completion
- Dec 2004 (actual)
- Study completion
- Dec 2004 (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 to compare the safety and effectiveness of 5 different ways of taking Pulmicort when given to asthma patients aged 12 years and above.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: BudesonidePulmicort RESPULES |
| 2 | Experimental | Drug: BudesonidePulmicort TURBUHALER |
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)
- Male or female aged 12 or over who have asthma
- Ability to properly use an electronic diary
- Able and willing to nebulize for up to 20 minutes every morning and evening
Key exclusion criteria (3 listed)
- Hospitalised at least one once or required emergency treatment due to asthma in the previous 6 months
- Planned hospitalisation during the study
- pregnant women or women planning to become pregnant
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 RESPULES0.5mg once daily | Drug | 1 |
| BudesonideAlso: Pulmicort RESPULES1mg once daily | Drug | 1 |
| BudesonideAlso: Pulmicort RESPULES1mg twice daily | Drug | 1 |
| BudesonideAlso: Pulmicort RESPULES2mg once daily | Drug | 1 |
| BudesonideAlso: Pulmicort TURBUHALER4.00mcg twice daily | Drug | 2 |
Primary outcome
Forced Expiratory Volume in 1 second in patients allocated treatment with Pulmicort REPSULES at 0.5mg and 2.0mg.
Time frame: Day -14, 1, and every 28 days thereafter
3 secondary outcomes
Percentage of symptom free days
Time frame: Day -14, 1, and every 28 days thereafter
Percentage of symptom free nights
Time frame: Day -14, 1, and every 28 days thereafter
Percentage of symptom free 24-hours
Time frame: Day -14, 1, and every 28 days 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 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.
Bertil Andersson study director
AstraZeneca
Questions about this trial
What is this clinical trial studying?
A Phase 3 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 24 Jan 2011. 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. 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?
Forced Expiratory Volume in 1 second in patients allocated treatment with Pulmicort REPSULES at 0.5mg and 2.0mg. (time frame: Day -14, 1, and every 28 days thereafter). 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.