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

Information source: GlaxoSmithKline
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Asthma

Intervention: Spirometry, PEF measurements and diary cards to evaluate control of Asthma (Other)

Phase: Phase 4

Status: Completed

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
GSK Clinical Trials, Study Director, Affiliation: GlaxoSmithKline

Summary

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.

Clinical Details

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.

Study design: Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: asthma control based on GINA guidelines from 2007.

Secondary outcome: Quality of Life, Health economics and exacerbations

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 evluations with diary cards, questionnaires, PEF evaluations and spirometry which is regarded as the intervention by the Swedish Authorities.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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 treatment 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 psychological handicap

- cerebro-vascular disease with handicap

- un-stable cancer

- known or planned pregnancy during the time of the study

- subjects who have serious uncontrolled disease

Locations and Contacts

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

Starting date: February 2009
Last updated: August 11, 2014

Page last updated: August 23, 2015

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