AsthmaINVOLVENCT00577265
An Observational Study to Investigate How Patients Experience the Ability to Adjust Their Asthma Maintenance Medication
An observational study of Asthma, run by AstraZeneca.
Trial summary
An observational study to investigate how patients experience the ability to adjust their asthma maintenance medication according to instructions received from their physician. The primary aim is to create an insight in the perception of the patient when he has the ability to adjust his own maintenance treatment and… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Asthma
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Nov 2004to 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: patients
Who may be able to join
- Inclusion Criteria: patients with prescription of budesonide/formoterol Turbuhaler 200/6 (adjustable maintenance dosing) and whom received instructions from their physician to adjust their asthma maintenance medication.
Who cannot join
None listed.
About this study
Official title: An Observational Study to Investigate How Patients Experience the Ability to Adjust Their Asthma Maintenance Medication According to Instructions Received From Their Physician (AMD).
An observational study to investigate how patients experience the ability to adjust their asthma maintenance medication according to instructions received from their physician. The primary aim is to create an insight in the perception of the patient when he has the ability to adjust his own maintenance treatment and how the patient exercises this in the daily practice.
- Conditions
- Asthma
- Keywords
- Asthma Control
- Medical subject headings
- Asthma
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary aim is to create an insight in the perception of the patient when he has the ability to adjust his own maintenance treatment and how the patient exercises this in the daily practice.
Secondary outcomes (1)
The secondary goal is to investigate the efficacy of the treatment with budesonide/formoterol AMD on the patients asthma control measured with the ACQ.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2007 (estimated)
- Study startNov 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
- Observational
- Time perspective
- Prospective
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Hannie de Munnik, Study director, AstraZenecaMonique Scholtes, Study chair, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00577265
- Sponsor's protocol ID
- S43
- Acronym
- INVOLVE
- Status last verified
- Jan 2011
- First submitted
- 18 Dec 2007
- Last updated
- 28 Jan 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Study to Investigate How Patients Experience the Ability to Adjust Their Asthma Maintenance Medication According to Instructions Received From Their Physician (AMD).
- ClinicalTrials.gov ID
- NCT00577265
- Acronym / sponsor ID
- INVOLVE / S43
- Conditions
- Asthma
- Keywords
- Asthma Control
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Nov 2004
- First posted
- 20 Dec 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.
An observational study to investigate how patients experience the ability to adjust their asthma maintenance medication according to instructions received from their physician. The primary aim is to create an insight in the perception of the patient when he has the ability to adjust his own maintenance treatment and how the patient exercises this in the daily practice.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- patients
Key inclusion criteria (1 listed)
- Inclusion Criteria: patients with prescription of budesonide/formoterol Turbuhaler 200/6 (adjustable maintenance dosing) and whom received instructions from their physician to adjust their asthma maintenance medication.
Key exclusion criteria (0 listed)
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
The primary aim is to create an insight in the perception of the patient when he has the ability to adjust his own maintenance treatment and how the patient exercises this in the daily practice.
1 secondary outcome
The secondary goal is to investigate the efficacy of the treatment with budesonide/formoterol AMD on the patients asthma control measured with the ACQ.
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 28 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.
Hannie de Munnik study director
AstraZeneca
Monique Scholtes study chair
AstraZeneca
Questions about this trial
What is this clinical trial studying?
An observational study of 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 1 inclusion and 0 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 28 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.
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?
The primary aim is to create an insight in the perception of the patient when he has the ability to adjust his own maintenance treatment and how the patient exercises this in the daily practice.. 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 28 Jan 2011.