New Data Demonstrates SYMBICORT TURBUHALER SMART Reduces Exacerbations In Asthma Patients And Helps To Control The Disease

Main Category: Respiratory / Asthma
Article Date: 08 Oct 2008 - 4:00 PDT

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New data from the CHAMPION studies presented today at the European Respiratory Society (ERS) congress confirms that Symbicort (budesonide/formoterol) Turbuhaler Maintenance and Reliever Therapy (Symbicort Turbuhaler SMART) patients experience fewer asthma exacerbations and improved asthma control compared to local guideline-based conventional best practice (CBP).1 Additional new data showed that budesonide/formoterol maintenance and reliever therapy also reduces the risk of asthma exacerbations and rate of hospital/ER visits compared to a fixed higher dose of inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA) plus short-acting beta-agonist (SABA) in moderate/severe asthma.2 A further data analysis showed that achieving well-controlled asthma was at least as likely and the ability to prevent uncontrolled asthma was superior with budesonide/formoterol maintenance and reliever therapy compared to the comparator treatments (fixed higher dose ICS/LABA plus SABA).3

Budesonide/formoterol maintenance and reliever therapy is a patient focussed management approach for improving asthma control and reducing exacerbations. This treatment strategy provides daily maintenance therapy and symptom relief (as needed) in the same inhaler. In doing so, patients are able to treat or prevent the underlying inflammation of their airways with every inhalation, whether used for maintenance or symptom relief.

The analysis of the pooled CHAMPION studies,1 presented at ERS by Professor Pascal Demoly, showed that for patients in the budesonide/formoterol maintenance and reliever therapy group, the risk of first exacerbation (HR) versus conventional therapy was 0.86 (95% CI 0.74, 1.01; P=0.062). Also, those in the budesonide/formoterol maintenance and reliever therapy group experienced 15 percent fewer asthma exacerbations over the study period (0.20 vs. 0.24 patient/year; p=0.02) and fewer exacerbation days (totals 2753 vs. 3801; p<0.0001) compared to CBP.1 This analysis was based on studies conducted across several countries with varying local guideline-based CBP.

A higher proportion of the CHAMPION1 population achieved well controlled asthma with budesonide/formoterol maintenance and reliever therapy compared to CBP (45 percent vs. 41 percent respectively, p<0.01).1 The proportion of patients with uncontrolled asthma was also lower, 25 percent of the budesonide/formoterol maintenance and reliever therapy group vs. 29 percent in CBP (OR 0.81; p<0.01).1

"These findings indicate that whatever their local standard best practice asthma management strategy, patients may benefit from a positive change towards simpler and more effective treatments to reduce the incidence of asthma exacerbations," said Professor Pascal Demoly of the Allergy Department, University Hospital Montpellier and lead investigator for CHAMPION.

An additional pooled analysis presented by Professor Paul O'Byrne further demonstrated that budesonide/formoterol maintenance and reliever therapy reduces the rate of asthma exacerbations and the rate of hospital/ER visits compared with three alternative fixed-dose regimen plus SABA as comparators: versus higher maintenance ICS (annual rate/100 patients;19 vs. 34 for exacerbations; 2 vs. 3 for hospital/ER events), versus a similar maintenance dose of budesonide/formoterol (annual rate/100 patients 21 vs. 40 for exacerbations; 4 vs. 7 for hospital/ER events) and also versus higher maintenance dose of ICS/LABA (annual rate/100 patients; 28 vs. 39 exacerbations; 13 vs. 17 hospital/ER events).2

A further post hoc analysis presented by Professor Eric Bateman of the University of Cape Town Lung Institute, budesonide/formoterol maintenance and reliever therapy (compared to a fixed higher dose of inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA) plus short-acting beta-agonist (SABA)) reduced the risk of having an exacerbation (9% vs. 12%; p=0.001) while at the same time reducing the proportion of patients (previously symptomatic on moderate-to-high doses of ICS) whose asthma remained uncontrolled (26% vs. 30%; p=0.035) as defined using the Asthma Control Questionnaire.3 This was achieved with a lower mean dose of ICS (1000 μg/d vs. 1341 μg/d in BDP equivalents).3

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SYMBICORT, SYMBICORT SMART AND TURBUHALER are trade marks of the AstraZeneca group of companies

Demoly et al data (CHAMPION)1

- The CHAMPION study was conducted to examine the efficacy of budesonide/formoterol maintenance and reliever therapy compared to local guideline-based conventional best practice (CBP)

- The pooled analysis examined clinical control and risk of exacerbations in asthmatics (≥ 12 years) during 6-month open-label studies in 6 studies performed in several countries, performed to the same core protocol

- CBP included ICS or ICS/LABA at any dose with our without other agents such as leukotriene agonists and as needed SABA

Results showed that:

- Exacerbations that were defined by oral steroid use were 0.146 per year with budesonide/formoterol maintenance and reliever therapy compared to 0.179 per year with CBP (p=0.01)

- The risk of a first exacerbation (primary variable) was not significantly reduced with budesonide/formoterol maintenance and reliever therapy (HR 0.86; 95% CI 0.74, 1.01;p=0.062)

- Patients treated with budesonide/formoterol maintenance and reliever therapy experienced 15 percent fewer exacerbations, 0.20 vs. 0.24 patient per year (p=0.02)

- A lower incident of exacerbation days were seen in patients treated with budesonide/formoterol maintenance and reliever therapy (totals 2753 vs. 3801; p<0.0001)

- Budesonide/formoterol maintenance and reliever therapy was associated with a higher percentage of patients achieving well controlled asthma compared to patients treated by conventional best practice (45% vs. 41%; p<0.01)

- Budesonide/formoterol maintenance and reliever therapy is more effective at reducing uncontrolled asthma (25 percent vs. 29 percent, OR 0.81; p<0.01)

O'Byrne et al data2

- The O'Byrne et al study looked to compare budesonide/formoterol maintenance and reliever therapy with 2 to 4 fold higher maintenance therapy (ICS), maintenance budesonide/formoterol at the same dose (but with a separate SABA), and higher maintenance ICS/LABA (budesonide/formoterol or salmeterol/fluticasone)

- All comparators used SABA as needed

- The pooled analysis looked at six double blind studies of equal or more than six months duration and assessed the rate of asthma exacerbations and hospital/ER visits

- Exacerbations requiring oral steroids and/or hospitalisation/emergency room (H/ER) visits were analysed and the number needed to treat (NNT) to prevent one of each type of exacerbation was estimated

Results showed that:

- Budesonide/formoterol maintenance and reliever therapy reduced the rate of asthma exacerbations and hospital/emergency room visits compared with traditional fixed dose regimen plus SABA comparators

- When budesonide/formoterol maintenance and reliever therapy is compared with a higher dose of ICS, per 100 patients, the rate of exacerbation was 19 versus 34 in the comparator group

- In the same group, those on budesonide/formoterol maintenance and reliever therapy showed a reduction in hospitalisation/emergency room visits, with 2 visits versus 3 for the patients on higher doses of ICS

- When budesonide/formoterol maintenance and reliever therapy is compared with maintenance budesonide/formoterol at the same dose but with a separate SABA, per 100 patients, the rate of exacerbations was significantly reduced at 21 versus 40 in the comparator group

- Hospitalisation/emergency room visits were also reduced on budesonide/formoterol maintenance and reliever therapy, with 4 visits versus 7 visits seen in the patient group taking budesonide/formoterol maintenance and separate reliever therapy (LABA)

- When compared with higher maintenance ICS/LABA (budesonide/formoterol or salmeterol/fluticasone), budesonide/formoterol maintenance and reliever therapy showed a reduction in the rate of exacerbations of 28 versus 39, per 100 patients

- The same group of patients saw a reduction in hospitalisation/emergency room visits of 13 versus 17 on budesonide/formoterol maintenance and reliever therapy compared with the comparator group on maintenance ICS/LABA (budesonide/formoterol or salmeterol/fluticasone), per 100 patients

Bateman et al data3

- The Bateman et al study looked to compare current clinical control and reduction in the future risk of exacerbations with moderate-to-high dose ICS/LABAs or budesonide/formoterol maintenance and reliever therapy in patients symptomatic on moderate-to-high dose ICS

- The percentage of patients with one or more exacerbation (hospitalisation/emergency room visits or oral steroid use) and percentage of controlled and uncontrolled asthma patients was assessed by a validation questionnaire

Results showed that:

- Budesonide/formoterol maintenance and reliever therapy reduces the risk of exacerbations and uncontrolled asthma with a similar probability of achieving clinical control versus fixed high dose ICS/LABA plus SABA in moderate/severe asthma

- Of the patients treated with budesonide/formoterol maintenance and reliever therapy 9 percent experienced ≥1 exacerbation (p=0.001) and 12 percent of patients treated with higher fixed dose-ICS/LABA plus SABA experienced ≥1 exacerbation

- Budesonide/formoterol maintenance and reliever therapy shows a similar probability of achieving clinical control as higher fixed dose-ICS/LABA plus SABA, with 44 percent and 43 percent of patients achieving asthma control respectively

- Budesonide/formoterol maintenance and reliever therapy reduced the percentage of patients with uncontrolled asthma; 26 percent compared to 30 percent of patients treated with higher fixed dose-ICS/LABA plus SABA (p=0.035)

Budesonide/Formoterol Maintenance and Reliever Therapy (Symbicort Turbuhaler SMART)

- Budesonide/formoterol maintenance and reliever therapy is a patient focussed management approach for improving asthma control and reducing future risk of exacerbations, in line with the practical realities for both the patient and the prescribing physicians

- Budesonide/formoterol maintenance and reliever therapy is the first treatment approach to provide patients with both asthma maintenance and reliever therapy together in one inhaler.

- This treatment approach is given an Evidence A rating in the most recent Global Initiative for Asthma's (GINA) guidance: Global Strategy for Asthma Management and Prevention4

- Patients prescribed budesonide/formoterol maintenance and reliever therapy take a maintenance dose of budesonide/formoterol everyday in line with normal practice to establish asthma control and take additional inhalations 'as needed' of budesonide/formoterol if symptoms occur, giving patients a unique opportunity to improve overall asthma control

- Budesonide/formoterol maintenance and reliever therapy successfully completed the European Union Mutual Recognition procedure (MRP) in October 2006 and it is currently approved in over 90 countries worldwide (outside US)

GINA: Global strategy for asthma management and prevention 20074

Updated in December 2007 the Global strategy for asthma management and prevention is evidence-based guidelines for asthma management and prevention, with citations from the scientific literature. Evidence is from endpoints of well designed randomised controlled trials (RCTs) that provide a consistent pattern of findings in the population for which the recommendation is made. Category A, the highest category, requires substantial numbers of studies involving substantial numbers of participants to provide a rich body of data.

SYMBICORT, SYMBICORT SMART AND TURBUHALER are trade marks of the AstraZeneca group of companies

References

1. Demoly P, Louis R, Søes-Petersen U et al; Overall asthma control with budesonide/formoterol maintenance and relief vs. conventional best practice. Abstract presented at ERS 2008.

2. O'Byrne PM and Bateman E; Preventing asthma exacerbations with budesonide/formoterol maintenance and relief: A pooled analysis. Abstract presented at ERS 2008.

3. Bateman E and O'Byrne P; Assessing overall asthma control with budesonide/formoterol maintenance and relief in moderate/severe asthma. Abstract presented at ERS 2008

4. Global Initiative for Asthma. Global strategy for asthma management and prevention 2007. Available from http://www.ginasthma.org Accessed September 8th, 2008.

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