REALITY: Physician and Patient Perception of Adjustable Maintenance Dosing of Symbicort Turbuhaler

• Sponsor: AstraZeneca (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00812682
• Collaborator: (none)
• Enrollment: 217
• Duration (Months): 11

Study Details

Study Description

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	Phase
Perception of Physicians & Patients of AMD	Drug: Symbicort

Study Design

• 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: Sep 1, 2006
• Actual Study Completion Date: Aug 1, 2007

Outcome Measures

Primary Outcome Measures

1. Patient satisfaction with the adjustable maintenance dosing schedule [Throughout the study]

2. Physicians' satisfaction with the adjustable maintenance dosing schedule [Throughout the study]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 12 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

No locations specified.

Sponsors and Collaborators

• AstraZeneca

Investigators

• Study Director: Panagiotis Pontikis, MD, Medical & Regulatory Affairs Director, AstraZeneca Greece: 4

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00812682
• Other Study ID Numbers: D5890L00021
• First Posted: Dec 22, 2008
• Last Update Posted: Jan 24, 2011
• Last Verified: Jan 1, 2011

• Keywords provided by , ,: SYMBICORT AMD
• Additional relevant MeSH terms: Budesonide, Formoterol Fumarate Drug Combination

Study Results

No Results Posted as of Jan 24, 2011