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Trial record 89 of 183 for:    Foradil Combi OR symbicort OR (Budesonide AND formeterol)

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

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ClinicalTrials.gov Identifier: NCT00858286
Recruitment Status : Completed
First Posted : March 9, 2009
Last Update Posted : August 13, 2014
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Brief 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.

Condition or disease Intervention/treatment Phase
Asthma Other: Spirometry, PEF measurements and diary cards to evaluate control of Asthma Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (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.
Study Start Date : February 2009
Actual Primary Completion Date : April 2010
Actual Study Completion Date : April 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

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




Primary Outcome Measures :
  1. asthma control based on GINA guidelines from 2007. [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. Quality of Life, Health economics and exacerbations [ Time Frame: 3 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00858286


Locations
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Sweden
GSK Investigational Site
Stockholm, Sweden, SE-171 77
Sponsors and Collaborators
GlaxoSmithKline
Investigators
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Study Director: GSK Clinical Trials GlaxoSmithKline

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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00858286     History of Changes
Other Study ID Numbers: 109780
First Posted: March 9, 2009    Key Record Dates
Last Update Posted: August 13, 2014
Last Verified: August 2014

Additional relevant MeSH terms:
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Budesonide, Formoterol Fumarate Drug Combination
Fluticasone-Salmeterol Drug Combination
Anti-Asthmatic Agents
Respiratory System Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Sympathomimetics