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

Condition(s) targeted: Asthma

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

Phase: Phase 4

Status: Completed

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
GSK Clinical Trials, MD, Study Director, Affiliation: GlaxoSmithKline

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.

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.

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

Primary outcome: 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:

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)

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

GSK Clinical Trials Call Center, Munchen 80339, Germany

GSK Clinical Trials Call Center, Munchen 80339, Germany

Starting date: May 2006
Last updated: November 9, 2007