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CompletedNCT00858286Updated Aug 13, 2014

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

A Phase 4 interventional study of Spirometry, PEF measurements and diary cards to evaluate control of Asthma in Asthma, sponsored by GlaxoSmithKline. Completed at 1 site in Sweden. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-08-13.

Sponsored by GlaxoSmithKline · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
56
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Asthma

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03

In context

Asthma

3,921 studies on the registry are indexed under Asthma; 507 are open to participants now.

This study's enrollment of 56 is below the median of 83 across 2,752 interventional studies indexed under Asthma.

Browse Asthma studies →

Lead sponsor

GlaxoSmithKline is the lead sponsor of 3,562 studies on the registry; 117 are open to participants now.

Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
56 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • OtherSpirometry, 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

06

What researchers measure

Primary outcomes

  1. asthma control based on GINA guidelines from 2007.

    Time frame: 3 months

Secondary outcomes

  1. Quality of Life, Health economics and exacerbations

    Time frame: 3 months

07

Study locations

1 site
  • GSK Investigational Site
    Stockholm, SE-171 77, Sweden
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 13, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00858286
Lead sponsor
GlaxoSmithKline
Responsible party
Sponsor
First posted
Mar 9, 2009
Start date
Feb 2009
Primary completion
Apr 2010
Completion
Apr 2010
Last update
Aug 13, 2014

Study contacts

GSK Clinical Trials
study director · GlaxoSmithKline

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2014. You cannot join it, but the record below documents what was studied.

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