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

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 4

Conditions: Asthma

Treatments: Drug: Salbutamol 100 mcg; Drug: Salmeterol/Fluticasone 50/250 mcg; Device: DISKUS™ powder inhalers

Study type: Interventional

Funder types: Industry

Identifiers

NCT00363480

SAM 106538

Details and patient eligibility

About

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.

Enrollment: 221 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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221 participants in 1 patient group

SFC 50/250 mcg

Experimental group

Description:

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.

Treatment:

Device: DISKUS™ powder inhalers

Drug: Salbutamol 100 mcg

Drug: Salmeterol/Fluticasone 50/250 mcg