natgillin/translations-raw huggingface dataset:
The extent of the adrenal impairment may require specialist advice before elective procedures. 
Raspon adrenalnih oštećenja može zahtijevati savjet stručnjaka prije elektivnih zahvata.
There is also an increased risk of systemic side effects when combining fluticasone propionate with other potent CYP3A inhibitors (see section 4.5). 
Postoji i povećani rizik od sustavnih nuspojava prilikom kombiniranja flutikazon propionata s drugim snažnim inhibitorima CYP3A (vidi odlomak 4.5.).
There was an increased reporting of lower respiratory tract infections (particularly pneumonia and bronchitis) in the TORCH study in patients with COPD receiving salmeterol/ fluticasone propionate compared with placebo (see section 4.8 and 5.1). 
Povećao se broj prijava infekcija donjeg respiratornog trakta (osobito pneumonija i bronhitisa) u TORCH ispitivanju u bolesnika s KOPB-om koji primaju salmeterol/flutikazon pripionat u usporedbi s placebom (vidi odlomak 4.8. i 5.1.).
In TORCH, older patients, patients with a lower body mass index (<;25kg/m2) and patients with very severe disease (FEV1<;30% predicted) were at greatest risk of developing pneumonia regardless of treatment. 
U TORCH-u, stariji bolesnici, bolesnici s nižim indeksom tjelesne težine (<; 25kg/m2) i bolesnici s vrlo teškom bolešću (FEV<; 30% predviđenog) imali su veći rizik od razvijanja pneumonije neovisno o liječenju.
Physicians should remain vigilant for the possible development of pneumonia and other lower respiratory tract infections in patients with COPD as the clinical features of such infections and exacerbation frequently overlap. 
Liječnici moraju biti na oprezu radi mogućeg razvoja pneumonije i drugih infekcija donjeg respiratornog trakta kod bolesnika s KOPB-om jer se klinički simptomi takvih infekcija i egzacerbacija često preklapaju.
If a patient with severe COPD has experienced pneumonia the treatment with salmeterol/ fluticasone propionate should be re-evaluated. 
Ako su bolesnici s teškim KOPB-om imali pneumoniju, mora se ponovo procijeniti liječenje salmeterol/flutikazon propionatom.
Data from a large clinical trial (the Salmeterol Multi-Center Asthma Research Trial, SMART) suggested African-American patients were at increased risk of serious respiratory-related events or deaths when using salmeterol compared with placebo (see section 5.1). 
Podaci velikog kliničkog ispitivanja (Multicentrično ispitivanje salmeterola u astmi, engl. SMART, the Salmeterol Multi-Center Asthma Research Trial) pokazuju da su bolesnici koji su afroamerikanci imali povećani rizik od teških štetnih događaja povezanih s disanjem ili od smrti tijekom uporabe salmeterola u usporedbi s placebom (vidi odlomak 5.1.).
It is not known if this was due to pharmacogenetic or other factors. 
Nije poznato jesu li uzrok tome farmakogenetski ili drugi čimbenici.
Patients of black African or Afro-Caribbean ancestry should therefore be asked to continue treatment but to seek medical advice if asthma symptoms remained uncontrolled or worsen whilst using salmeterol/ fluticasone propionate. 
Stoga, bolesnici crnačkog afričkog ili afrokaripskog podrijetla moraju nastaviti liječenje, ali potražiti savjet liječnika ako simptomi astme nisu pod kontrolom ili se pogoršaju tijekom uzimanja salmeterol/flutikazon propionata.
Concomitant treatment with ketoconazole or other potent CYP3A4 inhibitors should therefore be avoided unless the benefits outweigh the potentially increased risk of systemic side effects of salmeterol treatment (see section 4.5). 
Stoga, treba izbjegavati istovremeno liječenje ketokonazolom ili drugim snažnim inhibitorom CYP3A4 osim ako prednosti premašuju potencijalni povećani rizik od sustavnih nuspojava liječenja salmeterolom (vidi odlomak 4.5.).
Under normal circumstances, low plasma concentrations of fluticasone propionate are achieved after inhaled dosing, due to extensive first pass metabolism and high systemic clearance mediated by cytochrome P450 3A4 in the gut and liver. 
U normalnim okolnostima, nakon doziranja inhalacijom postižu se niske koncentracije flutikazon propionata u plazmi uslijed opsežnog metaboliziranja prilikom prvog prolaza i visokog sustavnog klirensa koji posreduje citokrom P450 3A4 u crijevu i jetri.
Hence, clinically significant drug interactions mediated by fluticasone propionate are unlikely. 
Stoga, nisu vjerojatne klinički značajne interakcije lijekova posredovane flutikazon propionatom.
In an interaction study in healthy subjects with intranasal fluticasone propionate, ritonavir (a highly potent cytochrome P450 3A4 inhibitor) 100 mg b.i.d. increased the fluticasone propionate plasma concentrations several hundred fold, resulting in markedly reduced serum cortisol concentrations. 
U ispitivanju interakcija na zdravim ispitanicima s intranazalnim flutikazon propionatom, ritonavir (visoko potentan inhibitor citokroma P450 3A4) 100 mg b.i.b. povećao je koncentracije flutikazon propionata u plazmi nekoliko stotina puta, što je dovelo do značajnog pada koncentracije kortizola u serumu.
Information about this interaction is lacking for inhaled fluticasone propionate, but a marked increase in fluticasone propionate plasma levels is expected. 
Informacije o ovim interakcijama manjkave su za inhalacijski flutikazon propionat, no očekuje se značajni porast razina flutikazon propionata u plazmi.
Cases of Cushing's syndrome and adrenal suppression have been reported. 
Prijavljeni su slučajevi Cushingovog sindroma i adrenalne supresije.
In a small study in healthy volunteers, the slightly less potent CYP3A inhibitor ketoconazole increased the exposure of fluticasone propionate after a single inhalation by 150%. 
U malom ispitivanju na zdravim dobrovoljcima, ketokonazol, nešto slabiji inhibitor CYP3A, povećao je izloženost flutikazon propionatu za 15% nakon jedne inhalacije.
Caution is recommended and long-term treatment with such drugs should if possible be avoided. 
Preporučuje se oprez i treba izbjegavati dugoročno liječenje takvim lijekovima.
Co-administration of ketoconazole (400 mg orally once daily) and salmeterol (50 mcg inhaled twice daily) in 15 healthy subjects for 7 days resulted in a significant increase in plasma salmeterol exposure (1.4-fold Cmax and 15-fold AUC). 
Istovremena uporaba ketokonazola (400 mg oralno jednom dnevno) i salmeterola (50 mikrograma inhalacijski dva puta dnevno) u 15 zdravih dobrovoljaca kroz 7 dana dovela je do značajnog povećanja izloženosti plazmatskom salmeterolu (1,4 puta Cmax i 15 puta PIK).
This may lead to an increase in the incidence of other systemic effects of salmeterol treatment (e.g. prolongation of QTc interval and palpitations) compared with salmeterol or ketoconazole treatment alone (see Section 4.4). 
To može dovesti do povećane incidencije drugih sustavnih nuspojava liječenja salmeterolom (npr. produženje QTc intervala i palpitacije) u usporedbi sa samostalnim liječenjem salmeterolom ili ketokonazolom (vidi odlomak 4.4.).
Co-administration with ketoconazole did not increase the elimination half-life of salmeterol or increase salmeterol accumulation with repeat dosing. 
Istovremena uporaba s ketokonazolom nije povećala vrijeme eliminacijskog poluživota salmeterola ili nakupljanje salmeterola s ponavljanim doziranjem.
Co-administration of erythromycin (500mg orally three times a day) and salmeterol (50mcg inhaled twice daily) in 15 healthy subjects for 6 days resulted in a small but non-statistically significant increase in salmeterol exposure (1.4-fold Cmax and 1.2-fold AUC). 
Istovremena uporaba eritromicina (500 mg oralno tri puta dnevno) i salmeterola (50 mikrograma inhalacijski dva puta dnevno) u 15 zdravih dobrovoljaca kroz 6 dana dovela je do malog, ali ne i statistički značajnog povećanja izloženosti salmeterolu (1,4 puta Cmax i 1,2 puta PIK).
4.6 Fertility, pregnancy and lactation 
4.6. Plodnost, trudnoća i dojenje
However, animal studies showed no effects of salmeterol or fluticasone propionate on fertility. 
No, ispitivanja na životinjama pokazala su da salmeterol i flutikazon nemaju utjecaj na plodnost.
A moderate amount of data on pregnant women (between 300-1000 pregnancy outcomes) indicate no malformative or feto/neonatal toxicity of salmeterol and fluticasone propionate. 
Umjerena količina podataka o trudnicama (između 300 - 1000 ishoda trudnoće) ne pokazuje malformacijsku ili feto/neonatalnu toksičnost salmeterola i flutikazon propionata.
Animal studies have shown reproductive toxicity after administration of beta-2-adrenoreceptor agonists and glucocorticosteroids (see section 5.3). 
Ispitivanja na životinjama pokazala su reproduktivnu toksičnost nakon primjene agonista beta-2-adrenoreceptora i glukokortikoida (vidi odlomak 5.3.).
Administration of Salmeterol/Fluticasone Pharos to pregnant women should only be considered if the expected benefit to the mother is greater than any possible risk to the foetus. 
Davanje lijeka Salmeterol/Fluticasone Pharos trudnicama dolazi u obzir ako je očekivana prednost za majku veća od svih mogućih rizika za fetus.
Studies have shown that salmeterol and fluticasone propionate, and their metabolites, are excreted into the milk of lactating rats. 
Ispitivanja su pokazala da se salmeterol i flutikazon te njihovi metaboliti izlučuju u mlijeko štakora.
A decision must be made whether to discontinue breast-feeding or to discontinue Salmeterol/Fluticasone Pharos therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman. 
Mora se odlučiti hoće li se prekinuti dojenje ili prestati uzimati Salmeterol/Fluticasone Pharos, uzimajući u obzir prednosti dojenja za dijete i prednosti liječenja za majku.
4.7 Effects on ability to drive and use machines 
4.7. Utjecaj na sposobnost upravljanja vozilima i strojevima
4.8 Undesirable effects 
4.8. Nuspojave
As Salmeterol/Fluticasone Pharos contains salmeterol and fluticasone propionate, the type and severity of adverse reactions associated with each of the compounds may be expected. 
S obzirom na to da Salmeterol/Fluticasone Pharos sadrži salmeterol i flutikazon propionat, može se očekivati tip i težina štetnih reakcija koje su povezane sa svakom od sastavnica.
Adverse events which have been associated with salmeterol/fluticasone propionate are given below, listed by system organ class and frequency. 
U nastavku su navedeni štetni događaji koji su povezani sa salmeterol/flutikazon propionatom, popisani po razredu prema organskim sustavima i učestalosti:
Frequencies are defined as: very common (≥1/10), common (≥1/100 and <;1/10), uncommon (≥1/1000 and <;1/100), rare (≥1/10,000 to <;1/1000), and very rare (<;1/10,000) including isolated reports. 
Učestalosti su određene kao: vrlo česte (>; 1/10), česte (≥ 1/100 i <; 1/10), manje česte (≥ 1/1000 i <; 1/100), rijetke (≥ 1/10,000 do <; 1/1000) i vrlo rijetke (<; 1/10,000), uključujući izolirana izvješća.
Very common, common and uncommon events were derived from clinical trial data. 
Vrlo česti, česti i manje česti događaji dobiveni su iz podataka kliničkih ispitivanja.
Very rare events were derived from post-marketing spontaneous data. 
Vrlo rijetki događaji izvedeni su iz podataka spontano dobivenih nakon stavljanja lijeka na tržište.
System Organ Class 
Razred organskog sustava
Angioedema (mainly facial and oropharyngeal oedema), Respiratory symptoms (dyspnoea and/or bronchospasm), Anaphylactic reactions including anaphylactic shock 
Angioedem (uglavnom lica i orofarinksa), respiratorni simptomi (dispneja i/ili bronhospazam), anafilaktičke reakcije, uključujući anafilaktički šok
Cushing's syndrome, Cushingoid features, Adrenal suppression, Growth retardation in children and adolescents, Decreased bone mineral density 
Cushingov sindrom, Cushingoidni simptomi, adrenalna supresija, usporavanje rasta u djece i adolescenata, smanjena mineralna gustoća kostiju
Psychomotor hyperactivity, sleep disorders, anxiety, depression, aggression and behavioural changes, (predominantly in children) 
Psihomotorna hiperaktivnost, poremećaji spavanja, anksioznost, depresija, agresija i promjene ponašanja (uglavnom u djece)
3Reported over 3 years in a COPD study 
3Prijavljene tijekom 3 godine ispitivanja KOPB-a
4See section 4.4 
4Vidi odlomak 4.4.
The pharmacological side effects of beta-2-agonist treatment, such as tremor, palpitations and headache, have been reported, but tend to be transient and reduce with regular therapy. 
Prijavljene su farmakološke nuspojave liječenja beta-2-agonistima, kao što su tremor, palpitacije i glavobolja, no uglavnom su prolazne i smanjuju se redovnom terapijom.
Due to the fluticasone propionate component, hoarseness and candidiasis (thrush) of the mouth and throat can occur in some patients. 
Zbog djelatne tvari flutikazon propionata, u nekih se bolesnika mogu javiti promuklost i kandidijaza usta i grla.
Both hoarseness and incidence of candidiasis may be relieved by gargling with water after using the product. 
I promuklost i incidencija kandidijaze mogu se smanjiti grgljanjem vode nakon uporabe lijeka.
Symptomatic candidiasis can be treated with topical anti-fungal therapy whilst still continuing with the Salmeterol/Fluticasone Pharos. 
Simptomatska kandidijaza može se liječiti topikalnim antifungalnim liječenjem uz daljnju uporabu lijeka Salmeterol/Fluticasone Pharos.
Pneumonia was reported in studies of patients with COPD (see section 5.1). 
Pneumonija je prijavljena u ispitivanjima bolesnika s KOPB-om (vidi odlomak 5.1.).
Possible systemic effects include Cushing's syndrome, Cushingoid features, adrenal suppression, growth retardation in children and adolescents, decrease in bone mineral density, cataract and glaucoma (see section 4.4). 
Mogući sustavni učinci uključuju Cushingov sindrom, Cushingoidne simptome, adrenalnu supresiju, usporavanje rasta u djece i adolescenata, smanjenje mineralne gustoće kostiju, kataraktu i glaukom (vidi odlomak 4.4.).
There have been very rare reports of hyperglycaemia (see section 4.4). 
Postoje rijetki izvještaji o hiperglikemiji (vidi odlomak 4.4.).
As with other inhalation therapy, paradoxical bronchospasm may occur (see section 4.4). 
Kao i s drugom inhalacijskom terapijom, mogu se javiti paradoksalni bronhospazmi (vidi odlomak 4.4.).
4.9 Overdose 
4.9. Predoziranje
There are no data available from clinical trials on overdose with salmeterol/ fluticasone propionate however data on overdose with both drugs are given below: 
Ne postoje dostupni podaci iz kliničkih ispitivanja o predoziranju salmeterol/flutikazon propionatom, no u nastavku su navedeni podaci o predoziranju s oba lijeka:
The preferred antidotes are cardioselective beta-blocking agents, which should be used with caution in patients with a history of bronchospasm. 
Preferirani antidoti su kardioselektivni beta-blokatori koji se moraju oprezno koristiti u bolesnika s brohnospazmom u anamnezi.
If Salmeterol/Fluticasone Pharos therapy has to be withdrawn due to overdose of the beta agonist component of the drug, provision of appropriate replacement steroid therapy should be considered. 
Ako se mora prekinuti liječenje Salmeterol/Fluticasone Pharosom uslijed predoziranja beta-agonistočkom sastavnicom lijeka, u obzir se mora uzeti davanje prikladnog zamjenskog liječenja steroidima.
Acute: 
Akutno:
Refer to section 4.4: risk of adrenal suppression: 
Pogledati odlomak 4.4.: rizici adrenalne supresije:
In cases of fluticasone propionate overdose Salmeterol/Fluticasone Pharos therapy may still be continued at a suitable dosage for symptom control. 
U slučajevima predoziranja flutikazon propionatom, može se i dalje nastaviti liječenje dozama Salmeterol/Fluticasone Pharosa koje su prikladne za kontrolu simptoma.
5.1 Pharmacodynamic properties 
5.1 Farmakodinamička svojstva
ATC Code: 
ATC (anatomsko-terapijsko-kemijski razred, engl. Anatomical Therapeutic Chemical Class) šifra:
A twelve month study (Gaining Optimal Asthma ControL, GOAL), in 3416 adult and adolescent patients with persistent asthma, compared the safety and efficacy of Salmeterol/Fluticasone propionate versus inhaled corticosteroid, ICS (Fluticasone Propionate) alone to determine whether the goals of asthma management were achievable. 
Ispitivanje u trajanju od dvanaest mjeseci (Postizanje optimalne kontrole astme, engl. GOAL, Gaining Optimal Asthma ControL) na 3416 odraslih i adolescentnih bolesnika s trajnom astmom uspoređivalo je podnošljivost i učinkovitost salmeterol/flutikazon propionata u odnosu na samostalan inhalacijski kortikosteroid, IKS (flutikazon propionat) kako bi se odredilo mogu li se postići ciljevi kontrole astme.
Treatment was stepped up every 12 weeks until **Total control was achieved or the highest dose of study drug was reached. 
Liječenje se postupno pojačavalo svakih 12 tjedana sve dok **nije uspostavljena potpuno kontrola ili dosegnuta najveća doza ispitivanog lijeka.
GOAL showed more patients treated with salmeterol/fluticasone propionate achieved asthma control than patients treated with ICS alone and this control was attained at a lower corticosteroid dose. 
GOAL je pokazao da je više bolesnika liječeno salmeterol/flutikazon propionatom postiglo kontrolu astme od bolesnika liječenih samostalnim IKS-om i da je ta kontrola postignuta s nižom dozom kortikosteroida.
Well Controlled asthma was achieved more rapidly with salmeterol/fluticasone propionate than with ICS alone. 
Dobra kontrola astme brže je postignuta sa salmeterol/flutikazon propionatom nego sa samostalnim IKS-om.
The time on treatment for 50% of subjects to achieve a first individual Well Controlled week was 16 days for salmeterol/fluticasone propionate compared to 37 days for the ICS group. 
Vrijeme liječenja potrebno da 50% ispitanika postigne prvi pojedinačni Dobro kontrolirani tjedan bilo je 16 dana sa salmeterol/flutikazon propionatom u usporedbi s 37 dana za skupinu s IKS-om.
In the subset of steroid naive asthmatics the time to an individual Well Controlled week was 16 days in the salmeterol/fluticasone propionate treatment compared to 23 days following treatment with ICS. 
U podskupini ispitanika s astmom koji ranije nisu koristili steroidne lijekove, vrijeme za postizanje pojedinačnog Dobro kontroliranog tjedna bilo je 16 dana u liječenju sa salmeterol/flutikazon propionatom u usporedbi s 23 dana u liječenju s IKS-om.
No ICS (SABA alone) 
Bez IKS-a (samo KDBA - kratkodjelujući beta-agonisti)
Low dose ICS (≤500mcg BDP or equivalent/day) 
Niska doza IKS-a (≤ 500mikrograma BDP-a (beklometazon dipropionat) ili ekvivalent/dan)
Medium dose ICS (500-1000 mcg 
Srednja doza IKS-a (500 - 1000 mikrograma
Pooled results across the 3 treatment levels 
Ukupni rezultati za sve 3 razine liječenja
*Well controlled asthma; occasional symptoms or SABA use or less than 80% predicted lung function plus no night-time awakenings, no exacerbations and no side effects enforcing a change in therapy 
*Dobro kontrolirana astma; povremeni simptomi ili uporaba KDBA-a ili manje od 80% predviđene plućne funkcije bez noćnih buđenja, bez egzacerbacija i bez nuspojava koje zahtijevaju promjenu liječenja
The results of this study suggest that salmeterol/fluticasone propionate 50/100mcg bd may be considered as initial maintenance therapy in patients with moderate persistent asthma for whom rapid control of asthma is deemed essential (see section 4.2). 
Rezultati ovog ispitivanja pokazuju da se salmeterol/flutikazon propionat 50/100 mikrograma b.i.b. može uzeti u obzir kao početna terapija održavanja u bolesnika s umjerenom trajnom astmom za koje je presudna brza kontrola astme (vidi odlomak 4.2.).
A double-blind, randomised, parallel group study in 318 patients with persistent asthma aged 18 years evaluated the safety and tolerability of administering two inhalations twice daily (double dose) of salmeterol/fluticasone propionate for two weeks. 
Dvostruko slijepo, randomizirano ispitivanje usporednih skupina s 318 ispitanika s trajnom astmom u dobi od 18 godina procijenilo je sigurnost i podnošljivost primjene dvije inhalacije dva puta dnevno (dvostruka doza) salmeterol/flutikazon propionata tijekom dva tjedna.
The study showed that doubling the inhalations of each strength of salmeterol/fluticasone propionate for up to 14 days resulted in a small increase in beta-agonist-related adverse events (tremor; 1 patient [1%] vs 0, palpitations; 6 [3%] vs 1 [<;1%], muscle cramps; 6[3%] vs 1 [<;1%]) and a similar incidence of inhaled corticosteroid related adverse events (e.g. oral candidiasis; 6 [6%] vs 16 [8%], hoarseness; 2 [2%] vs 4 [2%]) compared to one inhalation twice daily. 
Ispitivanje je pokazalo da udvostručavanje inhalacija obje jačine salmeterol/flutikazon propionata tijekom 14 dana dovodi do malog povećanja štetnih događaja vezanih uz beta-agonist (tremor; 1 bolesnik [1%] u odnosu na 0, palpitacije; 6 [3%] u odnosu na 1 [<; 1%], mišični grčevi; 6 [3%] u odnosu na 1 [<; 1%]) i slična incindencija štetnih događaja vezanih uz kortikosteroid (npr. oralna kandidijaza 6 [6%] u odnosu na 16 [8%], promuklost; 2 [2%] u odnosu na 4 [2%] u usporedbi s jednom inhalacijom dva puta dnevno.
The small increase in beta-agonist-related adverse events should be taken into account if doubling the dose of salmeterol/fluticasone propionate is considered by the physician in adult patients requiring additional short-term (up to 14 days) inhaled corticosteroid therapy. 
Malo povećanje učestalosti štetnih događaja vezanih uz beta-agonist mora se uzeti u obzir ako liječnik razmatra udvostručavanje doze salmeterol/flutikazon propionata u odraslih bolesnika koji zahtijevaju dodatno kratkotrajno (do 14 dana) liječenje inhalacijskim kortikosteroidima.
TORCH was a 3-year study to assess the effect of treatment with salmeterol/fluticasone propionate 50/500mcg bd, salmeterol 50mcg bd, fluticasone propionate (FP) 500mcg bd or placebo on all-cause mortality in patients with COPD. 
TORCH je bilo 3-godišnje ispitivanje za procjenu učinka liječenja sa salmeterol/flutikazon propionatom 50/500 mikrograma b.i.d., salmeterolom 50 mikrograma b.i.d., flutikazon propionat (FP) 500 mikrograma ili placebo na sveukupnu smrtnost u bolesnika s KOPB-om.
COPD patients with a baseline (pre-bronchodilator) FEV1 <;60% of predicted normal were randomised to double-blind medication. 
KOPB bolesnici s početnim (prije bronhodilatatora) FEV1-om <; 60% predviđene normale nasumično su raspoređeni u dvostruko slijepo liječenje.
During the study, patients were permitted usual COPD therapy with the exception of other inhaled corticosteroids, long acting bronchodilators and long-term systemic corticosteroids. 
Tijekom ispitivanja ispitanicima je dozvoljeno uobičajeno liječenje KOPB-a, osim drugih inhalacijskih kortikosteroida, dugodjelujućih bronhodilatatora i duodjelujućih sustavnih kortikosteroida.
Survival status at 3 years was determined for all patients regardless of withdrawal from study medication. 
Određeno je preživljavanje nakon 3 godine za sve ispitanike, neovisno o prekidu uzimanja ispitivanog lijeka.
The primary endpoint was reduction in all cause mortality at 3 years for salmeterol/fluticasone propionate vs Placebo. 
Primarna krajnja točka bila je smanjenje ukupne smrtnosti u 3 godine za salmeterol/flutikazon propionat u odnosu na placebo.
There was a trend towards improved survival in subjects treated with salmeterol/fluticasone propionate compared with placebo over 3 years however this did not achieve the statistical significance level p≤0.05. 
Postojao je trend prema povećanom preživljavanju u ispitanika liječenih sa salmeterol/flutikazon propionatom u usporedbi s placebom kroz 3 godine, međutim to nije dostiglo statistički značajnu razinu p ≤ 0,05.
The mean number of moderate to severe exacerbations per year was significantly reduced with salmeterol/fluticasone propionate as compared with treatment with salmeterol, FP and placebo (mean rate in the salmeterol/fluticasone propionate group 0.85 compared with 0.97 in the salmeterol group, 0.93 in the FP group and 1.13 in the placebo). 
Srednji broj umjerenih do teških egzacerbacija po godini bio je značajno smanjen salmeterol/flutikazon propionatom u usporedbi s liječenjem salmeterolom, FP-om i placebom (srednja stopa u skupini sa salmeterol/flutikazon propionatom bila je 0,85 u uspredbi s 0,97 u skupini sa salmeterolom, 0,93 u FP skupini i 1,13 s placebom).