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

Tracking Information

First Received Date ^ICMJE

August 10, 2006

Last Updated Date

May 15, 2009

Start Date ^ICMJE

May 2006

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00363480 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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)

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Results Of Patient Rated Asthma Control Test In Comparison To Diary Card Data

Official Title ^ICMJE

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.

Brief Summary

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.

Detailed Description

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study

Condition ^ICMJE

Asthma

Intervention ^ICMJE

Drug: Fluticasone propionate/salmeterol(50/250µg)

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

250

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Germany

Administrative Information

NCT ID ^ICMJE

NCT00363480

Responsible Party

Study Director, GSK

Study ID Numbers ^ICMJE

SAM 106538, VIA-CONTROL

Study Sponsor ^ICMJE

GlaxoSmithKline

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

Information Provided By

GlaxoSmithKline

Verification Date

May 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP