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Salmeterol/fluticasone propionate combination.

C M Spencer¹, B Jarvis

¹Adis International Limited, Mairangi Bay, Auckland, New Zealand. demail@adis.co.nz

|July 10, 1999

Summary

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Adding salmeterol (long-acting beta2-agonist) to inhaled corticosteroids improves persistent asthma symptoms more than increasing corticosteroid dosage. Fixed combination therapy is safe and effective for adults and children.

Area of Science:

Respiratory Medicine
Pharmacology

Background:

Persistent asthma requires effective long-term management.
Inhaled corticosteroids (ICS) are a cornerstone therapy.
Long-acting beta2-agonists (LABAs) offer bronchodilation.

Purpose of the Study:

To evaluate the efficacy and safety of fixed-combination salmeterol/fluticasone propionate (SFC) in persistent asthma.
To compare SFC to increasing ICS dosage and monotherapy.

Main Methods:

Clinical trials involving adults and children with persistent asthma.
Administration of SFC via Diskus powder inhaler in various strengths.
Assessment of pharmacodynamic, pharmacokinetic, and adverse effect profiles.

Main Results:

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SFC provides greater clinical benefit than doubling ICS dosage.
SFC shows improved lung function compared to monotherapy.
No adverse interactions affecting drug profiles or cortisol levels observed.
Efficacy comparable to separate inhalers and superior to budesonide in preliminary reports.

Conclusions:

Fixed-combination SFC is a safe and effective treatment for persistent asthma in adults and children.
SFC offers superior efficacy compared to increasing ICS dosage and is non-inferior to separate inhalers.
Common adverse effects include oropharyngeal candidiasis and hoarseness, occurring in <5% of patients.