Real-world Effectiveness and Cost-effectiveness of HFA-beclometasone Compared With ICS/LABA Combination Therapy

• Status: Completed
• Trial end date: 2010-02-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will compare the effectiveness, cost-effectiveness and direct healthcare costs of asthma management in patients with evidence of persistent asthma following an increase in asthma therapy in the form of either an increased dose of inhaled glucocorticosteroids (ICS) using extrafine hydrofluoroalkane-beclometasone dipropionate (HFA-BDP) via pressurised metered-dose inhaler (pMDI) or breath-actuated inhaler (BAI), or a change to combination ICS plus long-acting bronchodilator (LABA) therapy using fixed combinations (fluticasone propionate / salmeterol [FP/SAL] or budesonide / formoterol [BUD/FOR]) or separate pMDIs and BAIs.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Research in Real-Life Ltd
• Collaborators: Teva Branded Pharmaceutical Products R&D, Inc.; Teva Pharmaceutical Industries
• Treatments: Beclomethasone

Criteria

Inclusion Criteria:

• Aged: 4-60 years:

• Paediatric cohort (aged 4-11 years), and

• Adult cohort (aged 12-60 years)

• Aged 61-80 years and never smoked for an additional elderly cohort;

• Evidence of asthma: i.e. a diagnostic code of asthma or at least 2 asthma prescriptions, including one ICS prescription, at different points in time during the year prior to IPD (the baseline year)

• Be on current asthma therapy: i.e. at least 1 asthma prescription in the year prior to IPD, and at least 1 other asthma prescription during the same period

• Have at least one year of up-to-standard (UTS) baseline data (prior to the IPD) and at least one year of UTS outcome data (following the IPD).

Exclusion Criteria:

• had a diagnostic read code for chronic obstructive pulmonary disease (COPD) at any time

• had a diagnostic read code for chronic respiratory disease at any time (other than asthma)

• any patients receiving a combination inhaler in addition to their separate ICS inhaler in the baseline year