Physician and Patient Perception of Adjustable Maintenance Dosing of Symbicort Turbuhaler
Overview[ - collapse ][ - ]
| Purpose | 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. |
|---|---|
| Condition | Perception of Physicians & Patients of AMD |
| Intervention | Drug: Symbicort |
| Phase | N/A |
| Sponsor | AstraZeneca |
| Responsible Party | AstraZeneca |
| ClinicalTrials.gov Identifier | NCT00812682 |
| First Received | December 19, 2008 |
| Last Updated | January 21, 2011 |
| Last verified | January 2011 |
Tracking Information[ + expand ][ + ]
| First Received Date | December 19, 2008 |
|---|---|
| Last Updated Date | January 21, 2011 |
| Start Date | September 2006 |
| Estimated Primary Completion Date | August 2007 |
| Current Primary Outcome Measures |
|
| Current Secondary Outcome Measures | Not Provided |
Descriptive Information[ + expand ][ + ]
| Brief Title | Physician and Patient Perception of Adjustable Maintenance Dosing of Symbicort Turbuhaler |
|---|---|
| Official Title | Physician and Patient Perception of Adjustable Maintenance Dosing of Symbicort Turbuhaler |
| Brief 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. Patients and physicians perception of this new dosing schedule will be evaluated by means of questionnaires completion and direct questioning. |
| Detailed Description | Not Provided |
| Study Type | Observational |
| Study Phase | N/A |
| Study Design | Observational Model: Case-Only, Time Perspective: Prospective |
| Condition | Perception of Physicians & Patients of AMD |
| Intervention | Drug: Symbicort |
| Study Arm (s) | Not Provided |
Recruitment Information[ + expand ][ + ]
| Recruitment Status | Completed |
|---|---|
| Estimated Enrollment | 217 |
| Estimated Completion Date | August 2007 |
| Estimated Primary Completion Date | Not Provided |
| Eligibility Criteria | Inclusion Criteria: - 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). Exclusion Criteria: - 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 |
| Gender | Both |
| Ages | 12 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Not Provided |
| Location Countries | Not Provided |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT00812682 |
|---|---|
| Other Study ID Numbers | D5890L00021 |
| Has Data Monitoring Committee | No |
| Information Provided By | AstraZeneca |
| Study Sponsor | AstraZeneca |
| Collaborators | Not Provided |
| Investigators | Study Director: Panagiotis Pontikis, MD Medical & Regulatory Affairs Director, AstraZeneca Greece: 4 |
| Verification Date | January 2011 |