A Follow-up Survey to Compare Stable Dosing (SERETIDE) With SYMBICORT, SMART, Maintenance and Reliever Therapy in One Inhaler in Moderate and Severe Asthmatics. - Full Text View

Sponsor:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00858286

Purpose

The purpose with this study is to describe in detail the control or lack of control of asthma, based on two different dosing strategies, regular treatment with SERETIDE in a stable dosing with short acting beta-2 agonists as needed, or maintenance treatment with SYMBICORT and using the same inhaler with SYMBICORT as needed.

Condition	Intervention	Phase
Asthma	Other: Spirometry, PEF measurements and diary cards to evaluate control of Asthma	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Follow-up Survey to Compare Stable Dosing (SERETIDE) With SYMBICORT SMART, Maintenance and Reliever Therapy in One Inhaler in Moderate and Severe Asthmatics.

Resource links provided by NLM:

MedlinePlus related topics: Asthma

Drug Information available for: Symbicort

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

asthma control based on GINA guidelines from 2007. [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Quality of Life, Health economics and exacerbations [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Enrollment:	56
Study Start Date:	February 2009
Study Completion Date:	April 2010
Primary Completion Date:	April 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Stable dosing with SERETIDE, short acting B-2agonist as needed Regular treatment with SERETIDE in a stable dosing with short acting beta-2 agonists as needed	Other: Spirometry, PEF measurements and diary cards to evaluate control of Asthma No intervention is made with the existing therapy, but patient will perform spirometry and PEF evaluations togehter with a registration of control of asthma in diary cards and health economic parameters in questionnaires
Experimental: Maintenance treatment with SYMBICORT and SYMBICORT as needed Maintenance treatment with SYMBICORT and using the same inhaler with SYMBICORT as needed	Other: Spirometry, PEF measurements and diary cards to evaluate control of Asthma No intervention is made with the existing therapy, but patient will perform spirometry and PEF evaluations togehter with a registration of control of asthma in diary cards and health economic parameters in questionnaires

Detailed Description:

The purpose with this study is to describe in detail the control or lack of control of asthma, based on two different dosing strategies. No therapy intervention is made with existing prescribed medications (SERETIDE or SYMBICORT), but evaluations outside standard care is made by avluations with diary cards, questionnaires, PEF evaluations and spirometry which is regarded as the intervention by the Swedish Authorities.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

written informed consent
18 years or above
able to fill in questionnaires and perform PEF measurements
asthma diagnosis and prescribed SERETIDE or SYMBICORT, either regular tretament using SERETIDE in a stable dosing and short acting B2 agonists as needed, or maintenance treatment with SYMBICORT but also using same inhaler SYMBICORT as needed

Exclusion Criteria:

no other lung disease
neurological disease with psycological handicap
cerebro-vascular disease with handicap
un-stable cancer
known or planned pregnancy during the time ofthe study
subjects who have serious uncontrolled disease

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00858286

Locations

Sweden
GSK Investigational Site
Stockholm, Sweden, SE-171 77

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier:	NCT00858286 History of Changes
Other Study ID Numbers:	109780
Study First Received:	February 19, 2009
Last Updated:	July 14, 2011
Health Authority:	Sweden: Medical Products Agency

Additional relevant MeSH terms:

Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Symbicort
Fluticasone, salmeterol drug combination

Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Pharmacologic Actions
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on February 09, 2012