Perception of Physicians & Patients of AMDREALITYNCT00812682
Physician and Patient Perception of Adjustable Maintenance Dosing of Symbicort Turbuhaler
An observational study of Perception of Physicians & Patients of AMD, run by AstraZeneca.
Trial summary
This study will evaluate the perception of the physicians and the patients about the approved adjustable dosing of Symbicort® 160/4,5. Symbicort maintenance dose will be adjusted up and down within the approved dose range of 1x2 - 4x2 inhalations per day, to the level of asthma symptoms. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Perception of Physicians & Patients of AMD
- What is being tested?
- Symbicort
- How many people
- 217 participants
- Where
- No sites listed yet
- Study dates
- Sep 2006to Aug 2007
- 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Primary Care
Who may be able to join
- Minimum of 6 months history of asthma and treatment with an inhaled corticosteroids for at least 3 months prior to visit 1 and/or a history of short term variation in airway function and asthma symptoms responding promptly to convent
- Patients where use of a combination (inhaled corticosteroid and long acting beta2-agonist is appropriate, i.e. not controlled on inhaled corticosteroids alone).
Who cannot join
- Asthma exacerbation requiring oral corticosteroid treatment in the four weeks prior to visit 1
- Upper Respiratory Tract Infection in the previous four weeks
- Severe cardiovascular disease or other significant concomitant disease, which may interfere with the conduct of the study.
- Women enrolled in the trial should not be planning pregnancy and should be taking adequate contraceptive measures where appropriate.
- Previous enrollment in a clinical study
- Known or suspected hypersensitivity to budesonide, formoterol or inhaled lactose
About this study
This study will evaluate the perception of the physicians and the patients about the approved adjustable dosing of Symbicort® 160/4,5. Symbicort maintenance dose will be adjusted up and down within the approved dose range of 1x2 - 4x2 inhalations per day, to the level of asthma symptoms. Patients and physicians perception of this new dosing schedule will be evaluated by means of questionnaires completion and direct questioning.
- Being tested
- Symbicort
- Keywords
- SYMBICORT AMD
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SymbicortDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient satisfaction with the adjustable maintenance dosing schedule
Measured: Throughout the study
Physicians' satisfaction with the adjustable maintenance dosing schedule
Measured: Throughout the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2008 (estimated)
- Study startSep 2006
- Study completionAug 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perception of Physicians & Patients of AMDStudies 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
- 217 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Panagiotis Pontikis, MD, Study director, Medical & Regulatory Affairs Director, AstraZeneca Greece: 4
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00812682
- Sponsor's protocol ID
- D5890L00021
- Acronym
- REALITY
- Status last verified
- Jan 2011
- First submitted
- 19 Dec 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
- Physician and Patient Perception of Adjustable Maintenance Dosing of Symbicort Turbuhaler
- ClinicalTrials.gov ID
- NCT00812682
- Acronym / sponsor ID
- REALITY / D5890L00021
- Keywords
- SYMBICORT AMD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 217 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Sep 2006
- Study completion
- Aug 2007 (actual)
- First posted
- 22 Dec 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.
This study will evaluate the perception of the physicians and the patients about the approved adjustable dosing of Symbicort® 160/4,5. Symbicort maintenance dose will be adjusted up and down within the approved dose range of 1x2 - 4x2 inhalations per day, to the level of asthma symptoms. Patients and physicians perception of this new dosing schedule will be evaluated by means of questionnaires completion and direct questioning.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Primary Care
Key inclusion criteria (2 listed)
- Minimum of 6 months history of asthma and treatment with an inhaled corticosteroids for at least 3 months prior to visit 1 and/or a history of short term variation in airway function and asthma symptoms responding promptly to convent
- Patients where use of a combination (inhaled corticosteroid and long acting beta2-agonist is appropriate, i.e. not controlled on inhaled corticosteroids alone).
Key exclusion criteria (6 listed)
- Asthma exacerbation requiring oral corticosteroid treatment in the four weeks prior to visit 1
- Upper Respiratory Tract Infection in the previous four weeks
- Severe cardiovascular disease or other significant concomitant disease, which may interfere with the conduct of the study.
- Women enrolled in the trial should not be planning pregnancy and should be taking adequate contraceptive measures where appropriate.
- Previous enrollment in a clinical 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 |
|---|---|---|
| Symbicort | Drug | – |
Primary outcome
Patient satisfaction with the adjustable maintenance dosing schedule
Time frame: Throughout the study
Physicians' satisfaction with the adjustable maintenance dosing schedule
Time frame: Throughout the study
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.
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.
Panagiotis Pontikis, MD study director
Medical & Regulatory Affairs Director, AstraZeneca Greece: 4
Questions about this trial
What is this clinical trial studying?
An observational study of Perception of Physicians & Patients of AMD, 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 2 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.
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?
Patient satisfaction with the adjustable maintenance dosing schedule (time frame: Throughout the study). The study lists 2 primary outcomes in all. 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.