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

NCT ID: NCT00858286

Last Updated: 2014-08-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-02-28

Study Completion Date

2010-04-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Asthma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Spirometry, PEF measurements and diary cards to evaluate control of Asthma

Intervention Type OTHER

No intervention is made with the existing therapy, but patient will perform spirometry and PEF evaluations together with a registration of control of asthma in diary cards and health economic parameters in questionnaires

Maintenance treatment with SYMBICORT and SYMBICORT as needed

Maintenance treatment with SYMBICORT and using the same inhaler with SYMBICORT as needed

Group Type EXPERIMENTAL

Spirometry, PEF measurements and diary cards to evaluate control of Asthma

Intervention Type OTHER

No intervention is made with the existing therapy, but patient will perform spirometry and PEF evaluations together with a registration of control of asthma in diary cards and health economic parameters in questionnaires

Interventions

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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 together with a registration of control of asthma in diary cards and health economic parameters in questionnaires

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Stockholm, , Sweden

Site Status

Countries

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Sweden

Other Identifiers

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109780

Identifier Type: -

Identifier Source: org_study_id

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