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Physician and Patient Perception of Adjustable Maintenance Dosing of Symbicort Turbuhaler (REALITY)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00812682
First Posted: December 22, 2008
Last Update Posted: January 24, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
AstraZeneca
  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 Intervention
Perception of Physicians & Patients of AMD Drug: Symbicort

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Physician and Patient Perception of Adjustable Maintenance Dosing of Symbicort Turbuhaler

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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 ]

Enrollment: 217
Study Start Date: September 2006
Study Completion Date: August 2007
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Primary Care
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00812682


Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Panagiotis Pontikis, MD Medical & Regulatory Affairs Director, AstraZeneca Greece: 4
  More Information

Responsible Party: Panagiotis Pontikis, MD, Medical & Regulatory Affairs Director, AstraZeneca Greece, AstraZeneca S.A., Greece
ClinicalTrials.gov Identifier: NCT00812682     History of Changes
Other Study ID Numbers: D5890L00021
First Submitted: December 19, 2008
First Posted: December 22, 2008
Last Update Posted: January 24, 2011
Last Verified: January 2011

Keywords provided by AstraZeneca:
SYMBICORT AMD

Additional relevant MeSH terms:
Budesonide, Formoterol Fumarate Drug Combination
Anti-Asthmatic Agents
Respiratory System Agents