Conditions: Asthma
Keywords: Asthma Asthma Control Test SERETIDE
Allocation: NON_RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 221
Healthy volunteers: no

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 Seretide (salmeterol/fluticasone combination, SFC) 50/250 µg twice daily. 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:

Arms:
arm 1: Participants received the combination product, fluticasone 250 microgram (mcg) plus salmeterol 50 mcg (SFC 50/250 mcg) for 12 weeks. Study treatment was received using DISKUS™ powder inhalers, one dose in morning and evening. Study medication was dispensed at visits 3, 4, and 5 for 30 days each. The participants were provided with salbutamol rescue medication if they developed acute asthmatic symptoms. This medication was provided in metered dose inhalers containing at least 200 puffs of 100 mcg salbutamol. Use of rescue medications was recorded in the participant's asthma diaries. Stable dosages of other concomitant medications were allowed if they had no impact on the outcome criteria.

Interventions: intervention 1: Salmeterol/Fluticasone 50/250 mcg intervention 2: Salbutamol 100 mcg intervention 3: DISKUS™ powder inhalers
Intervention descriptions: intervention 1: Participant received salmeterol/fluticasone combination 50/250 mcg using DISKUS™ powder inhalers. intervention 2: This medication was provided in metered dose inhalers containing at least 200 puffs of 100 mcg salbutamol. intervention 3: Participant received salmeterol and fluticasone using DISKUS™ powder inhalers.

Protocol document: