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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00812682
First received: December 19, 2008
Last updated: January 21, 2011
Last verified: January 2011
  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

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Patient satisfaction with the adjustable maintenance dosing schedule [ Time Frame: Throughout the study ] [ Designated as safety issue: No ]
  • Physicians' satisfaction with the adjustable maintenance dosing schedule [ Time Frame: Throughout the study ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00812682

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

No publications provided

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
Study First Received: December 19, 2008
Last Updated: January 21, 2011
Health Authority: Greece: National Organization of Medicines

Keywords provided by AstraZeneca:
SYMBICORT AMD

Additional relevant MeSH terms:
Symbicort
Budesonide
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Pharmacologic Actions
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on April 15, 2014