Reaching asthma control with salmeterol/fluticasone 50 / 250µg bd combination in steroid naive or low dose JCS patients by using the asthma control test (ACT) as measurement.

• Conditions: Asthma control

• Registration Number: EUCTR2006-000253-21-DE
• Lead Sponsor: GlaxoSmithKline GmbH & Co KG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-03-08
• Last Update Posted: 10 February 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

A patient must not be included in the clinical trial unless the following inclusion criteria are met at visit 1:
•The patient’s written consent statement for participation in the study is available.
•Male and female patients > 18 years of age with the diagnosis of perennial bronchial asthma.
•No prior treatment with oral steroids during the last 4 weeks preceding visit 1.
•In case of prior treatment with inhaled steroids during the last 4 weeks preceding visit 1, the following limits shall apply: BDP < 500 µg/d, fluticasone < 200 µg/d, budenoside < 400 µg/d, ciclesonide < 200 µg/d, and mometasone < 200 µg/d.
•No changes in the asthma medication during the last 4 weeks preceding visit 1.
•Reversibility testing: > 12% improvement in FEV1 from baseline after inhaling 200 µg salbutamol.
•The patient is prepared to replace his/her prior asthma medication during the treatment phase by the salmeterol/fluticasone combination preparation (50/250 µg) b.i.d from the Diskus® inhaler and use the CFC-free Sultanol® metered dose inhaler on a p.r.n. basis.
•P.r.n. use of short-acting beta-sympathomimetics or short-acting anticholinergics during the screening phase.
•The patient is prepared to perform daily PEF measurements and keep a diary.
•Women are only eligible for participation in the study if they
a.are not of childbearing potential
OR
b.are of childbearing potential, but have a negative (urine) pregnancy test at visit 1 and agree to use contraceptive measures (including abstinence) suitable to prevent pregnancy during the study.
Permissible methods of contraception are:
Complete abstinence from sexual intercourse for the duration of the study
Male partner who is sterile prior to the woman being included in the study and who is the patient’s only sexual partner
Levonorgestrel implant
Progesterone for injection
Oral contraceptives (either combined or progestin only)
Any IUD with published data showing a maximum expected failure rate of less than 1% per year
Other contraceptive method for which published data show a maximum expected failure rate of less than 1% per year
Barrier method if applied in combination with one of the above permissible methods
Prior to inclusion in the treatment phase (visit 3), the following criteria must be met in addition:
•Patients who failed to achieve the status of good control” according to the GOAL criteria during the screening phase (patients who achieved the status of good control” or were not assessable” will discontinue the study after the screening phase).
•No acute infection of the lower airways between visits 1 and 3.
•No asthma exacerbation requiring a change in asthma medication between visits 1 and 3.
•Women of childbearing potential must have a negative (urine) pregnancy test at visit 3.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

A patient must not be included in this clinical trial if one or several of the following exclusion criteria apply at visit 1:
•The patient participated in a clinical drug trial within the past 30 days or previously participated in this trial.
•The patient has a known fluticasone, salmeterol, or salbutamol intolerance.
•Female patients:
the patient is pregnant or breastfeeding,
the patient is of childbearing potential (i.e. physically capable of becoming pregnant) and does not use an adequate method of contraception.
•Treatment with an inhaled steroid within the 4 weeks immediately preceding visit 1 in one of the following dosages: BDP > 500 µg/d, fluticasone > 200 µg/d, budenoside > 400 µg/d, ciclesonide > 200 µg/d, and mometasone > 200 µg/d

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: This study is intended to test whether symptomatic asthma patients receiving no inhaled corticosteroid or low-dosed inhaled corticosteroids will achieve good” asthma control under treatment with the salmeterol/fluticasone 50/250 µg combination preparation applied twice daily with the Diskus® inhaler over a treatment period of 12 weeks and whether this improvement can be represented using the Asthma Control Test (ACT). ;Secondary Objective: In addition, the study will investigate if the treatment also results in an improvement of the Quality of life (AQLQ).;Primary end point(s): Number of patients having at least good” asthma control according to the GOAL criteria within the last 8 weeks of a 12 week therapy with the salmeterol/fluticasone 50/250 combination preparation applied twice daily as compared to the number of patients achieving an ACT score of 20 to 25 points over the last 4 weeks of the treatment period.