Physician and Patient Perception of Adjustable Maintenance Dosing of Symbicort Turbuhaler

NCT00812682 | Completed

• 1 other identifier: D5890L00021
• Study Type: observational
• Target: 217
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Perception of Physicians & Patients of AMD

Keywords

SYMBICORT AMD

Outcome Measures

Primary Outcomes (2)

• Patient satisfaction with the adjustable maintenance dosing schedule

  Throughout the study

• Physicians' satisfaction with the adjustable maintenance dosing schedule

  Throughout the study

Interventions

Symbicort DRUG

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Primary Care

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• AstraZeneca: lead

MeSH Terms

Interventions

Budesonide, Formoterol Fumarate Drug Combination

Intervention Hierarchy (Ancestors)

Formoterol Fumarate; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Budesonide; Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Drug Combinations; Pharmaceutical Preparations

Study Officials

• Panagiotis Pontikis, MD

  Medical & Regulatory Affairs Director, AstraZeneca Greece: 4

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 19, 2008
• First Posted: December 22, 2008
• Study Start: September 1, 2006
• Study Completion: August 1, 2007
• Last Updated: January 24, 2011

Record last verified: 2011-01