AsthmaNCT00514787
Be SMART NIS, Moderate to Servere Asthma Patient Observation
An observational study of Asthma, run by AstraZeneca at 1 site in Austria.
Trial summary
Screen for moderate to severe asthma patients with suboptimal asthma control (as defined by GINA-Guidelines). Document current asthma control status. Re-evaluate asthma therapy and document new therapy if applicable. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Asthma
- How many people
- 900 participants
- Where
- 1 siteAustria
- Study dates
- Start not givento not given
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Moderate to severe asthma with suboptimal control
Who cannot join
- Intermittent or mild asthma, patient with good asthma control
Trial locations and contacts
1 site in 1 country.
About this study
Screen for moderate to severe asthma patients with suboptimal asthma control (as defined by GINA-Guidelines). Document current asthma control status. Re-evaluate asthma therapy and document new therapy if applicable.
- Conditions
- Asthma
- Keywords
- Asthma, NIS
- Medical subject headings
- Asthma
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2007 (estimated)
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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 900 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Wolfgang Pohl, PHD, Study chair, Executive Board OGP (Austria Society of Pneumology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00514787
- Sponsor's protocol ID
- NIS-RAT-SYM-2007/1
- Status last verified
- Mar 2009
- First submitted
- 9 Aug 2007
- Last updated
- 27 Mar 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Be SMART NIS, Moderate to Servere Asthma Patient Observation
- ClinicalTrials.gov ID
- NCT00514787
- Acronym / sponsor ID
- NIS-RAT-SYM-2007/1
- Conditions
- Asthma
- Keywords
- Asthma, NIS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 900 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- First posted
- 10 Aug 2007 (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.
Screen for moderate to severe asthma patients with suboptimal asthma control (as defined by GINA-Guidelines). Document current asthma control status. Re-evaluate asthma therapy and document new therapy if applicable.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Moderate to severe asthma with suboptimal control
Key exclusion criteria (1 listed)
- Intermittent or mild asthma, patient with good asthma control
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 27 Mar 2009.
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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.
Wolfgang Pohl, PHD study chair
Executive Board OGP (Austria Society of Pneumology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma, run by AstraZeneca at 1 site in Austria.
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 1 inclusion and 1 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 27 Mar 2009. 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 Austria. 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.
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.
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 27 Mar 2009.