None listed
Conditions
Brief summary
Asthma is a common condition which can cause significant disruptions to everyday life. There are many different drugs to treat asthma including inhaled corticosteroids (ICS) and long-acting beta-agonists (LABAs). A key problem in treating asthma is that patients sometimes do not take their medication as prescribed. This is commonly seen with ICS as they are not perceived to provide immediate relief. Combination ICS/LABA inhalers have been developed, which could be expected to improve a patient’s ability to adhere to their prescription as fewer doses and inhalers are needed, compared with separate inhaler medication. The purpose of this study is to assess whether a combined ICS/LABA inhaler (Seretide) has any effect on adherence to prescribed dose compared with single dose inhalers containing Flixotide (fluticasone propionate) and Serevent (salmeterol). The study will involve a treatment period of 24 weeks and patients will attend the clinic at 6 weekly intervals. Patients will be randomly allocated to receive treatment by either combination or separate inhalers.
Interventions
Randomised, single-blind, parallel group, single centre study. Patients will receive fluticasone propionate (FP) and salmeterol, either as combination inhaler therapy or as separate inhalers. Participants will be advised to take their metered dose inhalers (2 puffs) twice daily, resulting in a daily dose of 500µg FP and 100µg salmeterol with both regimens. Adherence will be assessed by covert adherence monitors incorporated into all inhaler devices used. Treatment will be twice daily for 24 we
Randomised, single-blind, parallel group, single centre study. Patients will receive fluticasone propionate (FP) and salmeterol, either as combination inhaler therapy or as separate inhalers. Participants will be advised to take their metered dose inhalers (2 puffs) twice daily, resulting in a daily dose of 500µg FP and 100µg salmeterol with both regimens. Adherence will be assessed by covert adherence monitors incorporated into all inhaler devices used. Treatment will be twice daily for 24 weeks.
Sponsors
GlaxoSmithKline
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
16 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
Doctor diagnosis of asthma, Currently prescribed inhaled corticosteroids (ICS), Steady dose of ICS for at least one month, No exacerbation in the previous month requiring a GP or hospital visit, No exacerbation in the run-in period.
Exclusion criteria
History of clinically significant disease which may affect the outcome of the study, Currently prescribed combination therapy (inhaled corticosteroid and long acting beta agonist in combined inhaler), No known sensitivity to beta-agonists, salmeterol or any of its ingredients.
Outcome results
None listed