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

August 11, 2014 updated by: GlaxoSmithKline

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

56

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 together 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 together with a registration of control of asthma in diary cards and health economic parameters in questionnaires

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
asthma control based on GINA guidelines from 2007.
Time Frame: 3 months
3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Quality of Life, Health economics and exacerbations
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2009

Primary Completion (Actual)

April 1, 2010

Study Completion (Actual)

April 1, 2010

Study Registration Dates

First Submitted

February 19, 2009

First Submitted That Met QC Criteria

March 5, 2009

First Posted (Estimate)

March 9, 2009

Study Record Updates

Last Update Posted (Estimate)

August 13, 2014

Last Update Submitted That Met QC Criteria

August 11, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 109780

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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