Study

Intervention

Side effects

Comments

Dolor 2001

Fluticasone propionate 2 puffs ‐ total dose 200 µg or placebo nasal spray once daily in addition to 250 mg cefuroxime axetil orally twice daily and 2 puffs of xylometazoline hydrochloride twice daily

Headache, bloody nose, vaginal itching, yeast infection, nausea, stomach irritation, diarrhoea, increased congestion, hay fever, light‐headed, sore throat, thirsty, itching, rash, cough, fatigue, metallic taste, felt dried out, nasal tissue felt inflamed

No serious unexpected adverse events reported

Any adverse event ‐ 37% in the fluticasone group versus 20% in the placebo group (P value = 0.7) no statistical significant difference

Adverse events could be attributed also to the co‐treatment

Nayak 2002

Amoxicillin‐clavulanate potassium 875 mg
twice daily orally and MFNS 200, 400 µg or placebo nasal spray twice daily

Epistaxis was the most frequently reported adverse event
Nasal burning, irritation and headache occurred in less than 2% of any treatment group

Treatment well‐tolerated, adverse events similar for all 3 arms of mild/moderate intensity: 12%, 15%, 15% in the MFNS 400, 800 µg and placebo arms

50 patients discontinued treatment because of adverse events, most commonly diarrhoea and nausea due to the antibiotic and were equally distributed among groups. Epistaxis, nasal burning, irritation or infection were not a cause for discontinuation of treatment

Barlan 1997

Budesonide 50 µg or placebo nasal spray to each nostril bid in addition to amoxicillin clavulanate potassium 40 mg/kg/day tid

Rash after 1 week attributed to the antibiotic in 1 subject that was switched to cefaclor

No specific adverse events related to the INCS use were reported

Meltzer 2005

MFNS 200 µg once daily or twice daily nasal spray
Amoxicillin 500 mg tid
Placebo nasal spray and capsules

Headache and epistaxis were most common reported

Most adverse events were mild or moderate with a similar incidence among treatment groups: 36.2%,
35.4%, 33.5% and 38.1% with MFNS 200 µg, 400 µg,
amoxicillin and placebo
1%, 3%, 2% and 2% of participants discontinued treatment because of adverse events in the 200 µg, 400 µg INCS, antibiotic and placebo arms