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Fluticasone – oral inhalation

Classification: A

Drug products: Aerivio Spiromax, Airflusal Forspiro, Atemur Diskus, Brisomax Diskus, Brisomax Diskus forte, Flixotide Diskus, Flixotide Evohaler, Flixotide Evohaler 250 micrograms, Flixotide® Diskus®, Fluticasone Cipla, Flutide Diskus, Flutide Evohaler, Flutide® Diskus®, Flutide® Evohaler®, Flutiform, Flutiform K-haler, Icsori, Novucaeli, Relanio, RELVAR ELLIPTA, Salflumix Easyhaler, Salmeterol/Fluticasone Abacus Medicine, Salmeterol/Fluticasone Cipla, Salmeterol/Fluticasone Neutec, Salmeterol/Flutikason 2care4, Salmeterol/Flutikason Ebb, Salmex, Seretaide Diskus, Seretide Diskus, Seretide Diskus forte, Seretide Diskus mite, Seretide Diskus Mite, Seretide Evohaler, Seretide Evohaler forte, Seretide® Diskus®, Seretide® Diskus® forte, Seretide® Diskus® mite, Seretide® Evohaler®, Seretide® Evohaler® forte, Seretide® Evohaler® mite, Trelegy Ellipta, Veraspir Diskus

ATC code: R03AK06, R03AK10, R03AK11, R03AL08, R03BA05


There are some studies with analyses of sex differences in effect and safety of fluticasone but the results are contradictory and the clinical relevance is unclear.

Additional information

Pharmacokinetics and dosing

Both men and women have been included in most of the pharmacokinetic studies of fluticasone. However, no analysis of sex differences have been found and sex-divided data is lacking [5].


Difference between men and women in effects in the efficacy of fluticasone has been investigated in a post-hoc analysis of a large 1-year double-blind trial, TRISTAN where Chronic Obstructive Pulmonary Disease (COPD) patients (539 men, 180 women) were randomized to the salmeterol/fluticasone or placebo [6,7]. No differences between men and women was found for any study outcome; FEV improvement, a reduction in COPD exacerbation rate, a reduction in COPD exacerbation requiring treatment with oral corticosteroids and improvement in health status. The effect of fluticasone on airway responsiveness was investigated in a small 6 weeks randomized placebo-controlled study (10 men, 16 women in the fluticasone group) [8]. The multiple linear regression analysis found a greater effect of fluticasone in men than women (3.2 vs. 1.2 doublings, respectively, of the PD20 geometric mean). However, these findings may reflect the differences in airway responsiveness in general between men and women. The excess of bronchial hyperresponsiveness in women has also been reported [9].A post hoc-analysis to The TORCH study, a trial investigated the effect of fluticasone and/or salmeterol therapy (4631 men, 1481 women) over 3 years showed that women were 16% less likely to die over the period of the study compared to men [10]. However, correcting for important covariates, such as degree of airflow obstruction, body mass index, region of the world, and previous myocardial infarction, this difference was not statistically significant (HR 1.16). The causes of death were similar in men and women [11]. The ISOLDE study was a trial that randomized 752 patients with moderate to severe COPD to fluticasone or placebo for three years [12]. In a longer follow-up of >13 years of the subjects with moderate to severe COPD (280 men, 95 women), male sex was one of the factors, associated with higher mortality among other factors such as older age and more severe COPD [13].

Adverse effects

A study investigated hoarseness/dysphonia in 313 patients with bronchial asthma using the fluticasone dry powder inhalers, showed that women complain of hoarseness and dysphonia more frequently than men. The authors highlighted the importance of selecting the most suitable device in this group in order to enhance the adherence [14]. In a Chinese national pharmacy database (2191 men, 3313 women), men showed higher adherence to fluticasone treatment (23% in men vs. 21% in women) [15].

Reproductive health issues

Regarding teratogenic aspects, please consult Janusmed Drugs and Birth Defects (in Swedish, Janusmed fosterpåverkan).

Other information

In a study on inhalation technique using metered dose inhalers (33 men, 26 women), 75% of the participants had an incorrect inhalation technique, especially women, regardless of age. Only 4% of women and 43% of men had an acceptable inhalation technique. The authors speculate that this may add to the worse asthma prognosis in women, shown in a meta-analysis of six trials of randomly assigned asthma treatment [1].

Several studies have shown worse prognosis for women with asthma. In an observational registry study (416 men, 498 women), women were found to have more asthmatic symptoms, worse quality of life and require more health care due to their asthma [2]. In a Danish prospective study on hospitalization due to asthma (6104 men of whom 2.5% had asthma, 7436 women of whom 2.2% had asthma), women had a 1.7 higher relative risk to be hospitalized [3]. An observational study from Singapore found hospitalization due to asthma to be more common in boys than girls aged 0-4 years (boys/girls ratio 1.69). In adults aged 35-64 years, women were more hospitalized (men/women ratio 0.81) [4].

Updated: 2020-08-28

Date of litterature search: 2016-12-05


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  2. Osborne ML, Vollmer WM, Linton KL, Buist AS. Characteristics of patients with asthma within a large HMO: a comparison by age and gender. Am J Respir Crit Care Med. 1998;157:123-8. PubMed
  3. Prescott E, Lange P, Vestbo J. Effect of gender on hospital admissions for asthma and prevalence of self-reported asthma: a prospective study based on a sample of the general population Copenhagen City Heart Study Group. Thorax. 1997;52:287-9. PubMed
  4. Ng TP, Niti M, Tan WC. Trends and ethnic differences in asthma hospitalization rates in Singapore, 1991 to 1998. Ann Allergy Asthma Immunol. 2003;90:51-5. PubMed
  5. Mehta R, Riddell K, Gupta A, Louey MD, Chan RH. Comparison of the Pharmacokinetics of Salmeterol and Fluticasone Propionate 50/100 µg Delivered in Combination as a Dry Powder Via a Capsule-Based Inhaler and a Multi-Dose Inhaler. Clin Drug Investig. 2015;35:319-26. PubMed
  6. Vestbo J, Soriano JB, Anderson JA, Calverley P, Pauwels R, Jones P et al. Gender does not influence the response to the combination of salmeterol and fluticasone propionate in COPD. Respir Med. 2004;98:1045-50. PubMed
  7. Calverley P, Pauwels R, Vestbo J, Jones P, Pride N, Gulsvik A et al. Combined salmeterol and fluticasone in the treatment of chronic obstructive pulmonary disease: a randomised controlled trial. Lancet. 2003;361:449-56. PubMed
  8. Convery RP, Leitch DN, Bromly C, Ward RJ, Bartlett G, Hendrick DJ. Effect of inhaled fluticasone propionate on airway responsiveness in treatment-naive individuals--a lesser benefit in females. Eur Respir J. 2000;15:19-24. PubMed
  9. Leynaert B, Bousquet J, Henry C, Liard R, Neukirch F. Is bronchial hyperresponsiveness more frequent in women than in men? A population-based study. Am J Respir Crit Care Med. 1997;156:1413-20. PubMed
  10. Ishizuka T, Hisada T, Aoki H, Yanagitani N, Kaira K, Utsugi M et al. Gender and age risks for hoarseness and dysphonia with use of a dry powder fluticasone propionate inhaler in asthma. Allergy Asthma Proc. 2007;28:550-6. PubMed
  11. Bender BG, Pedan A, Varasteh LT. Adherence and persistence with fluticasone propionate/salmeterol combination therapy. J Allergy Clin Immunol. 2006;118:899-904. PubMed
  12. Calverley PM, Anderson JA, Celli B, Ferguson GT, Jenkins C, Jones PW et al. Salmeterol and fluticasone propionate and survival in chronic obstructive pulmonary disease. N Engl J Med. 2007;356:775-89. PubMed
  13. Celli B, Vestbo J, Jenkins CR, Jones PW, Ferguson GT, Calverley PM et al. Sex differences in mortality and clinical expressions of patients with chronic obstructive pulmonary disease The TORCH experience. Am J Respir Crit Care Med. 2011;183:317-22. PubMed
  14. Burge PS, Calverley PM, Jones PW, Spencer S, Anderson JA, Maslen TK. Randomised, double blind, placebo controlled study of fluticasone propionate in patients with moderate to severe chronic obstructive pulmonary disease: the ISOLDE trial. BMJ. 2000;320:1297-303. PubMed
  15. Bale G, Martínez-Camblor P, Burge PS, Soriano JB. Long-term mortality follow-up of the ISOLDE participants: causes of death during 13 years after trial completion. Respir Med. 2008;102:1468-72. PubMed
  16. Statistikdatabas för läkemedel. Stockholm: Socialstyrelsen. 2019 [cited 2020-03-10.] länk

Authors: Alaa Falemban, Linnéa Karlsson Lind

Reviewed by: Mia von Euler

Approved by: Karin Schenck-Gustafsson