Physician and Patient Perception of Adjustable Maintenance Dosing of Symbicort Turbuhaler - Full Text View

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00812682

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

Drug Information available for: Symbicort

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case-Only, 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 ]

Biospecimen Retention: None Retained

Biospecimen Description:

Enrollment:	217
Study Start Date:	August 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

Responsible Party:	AstraZeneca S.A., Greece ( Panagiotis Pontikis, MD, Medical & Regulatory Affairs Director, AstraZeneca Greece )
Study ID Numbers:	D5890L00021
Study First Received:	December 19, 2008
Last Updated:	December 19, 2008
ClinicalTrials.gov Identifier:	NCT00812682
Health Authority:	Greece: National Organization of Medicines

Keywords provided by AstraZeneca:

SYMBICORT AMD

Study placed in the following topic categories:

Symbicort

Additional relevant MeSH terms:

Respiratory System Agents
Therapeutic Uses
Anti-Asthmatic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 13, 2009