Results Of Patient Rated Asthma Control Test In Comparison To Diary Card Data - Full Text View

Purpose

The majority of asthma patients are not well controlled, despite the availability of asthma medication that could effectively treat the disease. In this study uncontrolled patients who are steroid-naive or on low dose inhaled corticosteroids will be treated with Salmeterol/Fluticasone combination (SFC) 50/250 µg bd. The asthma control test (ACT) will be used to detect differences in the level of asthma control during treatment. The study aims to show a correlation between improvements of ACT und the level of asthma control which will be reached by the patients.

The aim of the study is to show that most of symptomatic asthma patients can reach 'well controlled asthma' with SFC. We get information about ACT in daily practice and physicians are trained to use the asthma control test as a screening tool and for follow up of asthma management. Correlations are expected between the improvements in ACT, Quality of Life and asthma control according to the Gaining Optimal Asthma controL (GOAL) criteria.

Condition	Intervention	Phase
Asthma	Drug: Fluticasone propionate/salmeterol(50/250µg)	Phase IV

MedlinePlus related topics:

Asthma

ChemIDplus related topics:

Corticosteroids Fluticasone propionate Fluticasone Salmeterol Salmeterol xinafoate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Official Title:	Reaching Asthma Control With Salmeterol/Fluticasone 50/250 µg bd Combination in Steroid Naive or Low Dose Inhaled Corticoid Steroid Patients by Using Asthma Control Test (ACT) Comparison of Patient Self Rating With Diary Card Data.

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Number of well controlled patients according to GOAL criteria after 12 week treatment with SFC 50/250 µg bd compared to number of patients achieving an ACT score of 20-25 for the last 4 weeks of treatment period.

Secondary Outcome Measures:

Change of number of patients achieving an ACT score 20-25 after end of treatment compared to Visit 3
Change in Forced Expiratory Volume (FEV1)
Change in morning Peak Expiratory Volume (PEF)

Estimated Enrollment:	250
Study Start Date:	May 2006

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion criteria:

Diagnosis of asthma
Reversibility >12% after inhalation of 200 µg Salbutamol
willingness and ability to complete daily record card on daily basis and to measure morning PEF on daily basis
80% compliance in diary card completion asthma control status: Uncontrolled based on the GOAL criteria

Exclusion criteria:

Change of asthma medication during the last 4 weeks
Asthma exacerbation characterized by use of oral corticoids during the last 3 months Pretreatment with inhaled corticosteroids more than 500 mcg Beclometasondipropionat or equivalent per day or other controller therapy during the last 3 months
upper or lower respiratory tract infection during the RUN-IN period moderate or severe asthma exacerbation during the RUN-IN period
Non compliance with use of Discus, PEF-meter and incomplete diary card data

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00363480

Locations


Germany
	GSK Clinical Trials Call Center
	Munchen, Germany, 80339
	GSK Clinical Trials Call Center
	Munchen, Germany, 80339

Sponsors and Collaborators

GlaxoSmithKline

Investigators


Study Director:	GSK Clinical Trials, MD	GlaxoSmithKline

More Information

Study ID Numbers:	SAM 106538, VIA-CONTROL
First Received:	August 10, 2006
Last Updated:	November 9, 2007
ClinicalTrials.gov Identifier:	NCT00363480
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by GlaxoSmithKline:

Asthma

Asthma Control Test

SERETIDE

Study placed in the following topic categories:

Hypersensitivity

Lung Diseases, Obstructive

Salmeterol

Respiratory Tract Diseases

Lung Diseases

Hypersensitivity, Immediate

Fluticasone

Asthma

Respiratory Hypersensitivity

Additional relevant MeSH terms:

Anti-Inflammatory Agents

Respiratory System Agents

Neurotransmitter Agents

Bronchial Diseases

Immune System Diseases

Adrenergic beta-Agonists

Adrenergic Agents

Molecular Mechanisms of Pharmacological Action

Physiological Effects of Drugs

Anti-Asthmatic Agents

Anti-Allergic Agents

Adrenergic Agonists

Pharmacologic Actions

Autonomic Agents

Therapeutic Uses

Peripheral Nervous System Agents

Dermatologic Agents

Bronchodilator Agents

ClinicalTrials.gov processed this record on October 10, 2008

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00363480