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

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ClinicalTrials.gov Identifier: NCT00812682
Recruitment Status : Completed
First Posted : December 22, 2008
Last Update Posted : January 24, 2011
Sponsor:
Information provided by:
AstraZeneca

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.

Condition or disease Intervention/treatment
Perception of Physicians & Patients of AMD Drug: Symbicort

Study Type : Observational
Actual Enrollment : 217 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Physician and Patient Perception of Adjustable Maintenance Dosing of Symbicort Turbuhaler
Study Start Date : September 2006
Actual Study Completion Date : August 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. Patient satisfaction with the adjustable maintenance dosing schedule [ Time Frame: Throughout the study ]
  2. Physicians' satisfaction with the adjustable maintenance dosing schedule [ Time Frame: Throughout the study ]


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

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

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 Posted: December 22, 2008    Key Record Dates
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