Source: International Congress 2015 – New data on established treatments for asthma, COPD and bronchiectasis
Disease area: Airway diseases

Abstract

Objectives: The aim of the studies was to assess the bioequivalence of two DPIs containing budesonide and formoterol, being delivered via Elpenhaler^® and Turbuhaler^®, respectively. Two PK studies were conducted.Methods: The first study had an open, randomized, two-sequence, two-period, crossover, single dose design in 100 asthmatic patients under fasting conditions. Equivalence was assessed after single inhalation of each treatment with concomitant oral administration of activated charcoal to prevent GI absorption of the drugs. The second study had a two-stages, two sequences, four period, crossover, randomized, controlled, fully replicate design in 48 healthy volunteers.Primary PK parameters estimated, the area under the curve (AUC_0-t) and the maximum drug concentration in plasma (C_max). Equivalence was concluded since the 90% CI for the T/R ratio of AUC_0-t and C_max, is within the limits 0.80 to 1.25 as shown in the Tables below

Table 1: Bioequivalence comparison after the administration of activated charcoal

	BUDESONIDE		FORMOTEROL
	T/R	CI	T/R	CI
AUC (0-t)	88.05	81.25 to 95.41	96.07	92.63 to 99.64
AUC (0-inf)	88.69	82.43 to 95.42	99.17	95.51 to 102.98
Cmax	88.32	81.09 to 96.21	97.68	90.66 to 105.24

 

Table 2: Bioequivalence comparison without the administration of activated charcoal

	BUDESONIDE		FORMOTEROL
	T/R	CI	T/R	CI
AUC (0-t)	102.60	90.84 to 114.89	102.99	85.58 to 123.95
AUC (0-inf)	102.49	91.49 to 114.81	104.52	89.38 to 122.27
Cmax	91.42	80.38 to 103.98	101.89	89.04 to 116.55

 

Conclusions: Both studies showed the formulations are bioequivalent regarding both to rate and extent of absorption. Both treatments were well tolerated by the subjects.


Rating:

Share or cite this content

Citations should be made in the following way:
Katerina Athanassiou (Pikermi, Greece), Katerina Athanassiou, Luigi Silvestro, Simona Rizea Savu. Pharmacokinetic studies for the estimation of bioequivalence of two DPIs containing budesonide and formoterol. Eur Respir J 2015; 46: Suppl. 59, 2967

Member's Comments

No comment yet.

Related content which might interest you: Dose-proportional lung bioavailability of beclometasone dipropionate and formoterol fumarate across three different dose strenghts of CHF1535 pMDI Source: Annual Congress 2013 –Asthma and COPD drugs: efficacy, safety and pharmacoeconomics Year: 2013 A single-dose double-blind study comparing efficacy of two dry powder inhalers containing budesonide and formoterol in asthmatic patients Source: International Congress 2016 – Asthma management Year: 2016 Pharmacokinetic and pharmacodynamic evaluation after administration of beclomethasone dipropionate and formoterol fumarate as fixed or free metered-dose inhaler combination in adolescent asthma Source: Annual Congress 2013 –Asthma drugs: new findings Year: 2013 Assessment of the bioequivalence of two DPIs containing fluticasone and salmeterol, in patients with controlled or partly controlled asthma Source: International Congress 2016 – Clinical characteristics of asthma Year: 2016 Comparative efficacy and costs of the treatment of moderate to severe persistent asthma with a new dry-powder inhaled beclomethasone dipropionate and formoterol combination Source: Annual Congress 2013 –Health economics of airway diseases Year: 2013 Comparison of the pharmacokinetics and pharmacodynamics of once daily tiotropium Respimat® and tiotropium HandiHaler® in COPD patients Source: Annual Congress 2013 –LAMA, LABA, ICS and their combinations for the treatment of asthma and COPD Year: 2013 24-h efficacy and pharmacokinetics of tiotropium Respimat® 5 μg in patients with asthma Source: International Congress 2015 – Immune mechanisms in the human lung Year: 2015 Pharmacokinetics (PK), safety and tolerability of abediterol and mometasone furoate fixed- and free-dose combinations in healthy subjects Source: International Congress 2014 – Novel approaches and evidence for drug development in respiratory diseases Year: 2014 Once-daily tiotropium and olodaterol fixed-dose combination via the respimat improves outcomes vs mono-components in COPD in two 1-year studies Source: International Congress 2014 – Bronchodilators for asthma and COPD Year: 2014 Once-daily tiotropium Respimat add-on to at least ICS in adult patients with symptomatic asthma: Pooled safety analysis Source: International Congress 2014 – Asthma and COPD management Year: 2014 In vitro validation of the use of a spacer with an extrafine beclomethasone/formoterol formulation Source: International Congress 2016 – Pulmonary drug delivery Year: 2016 Tiotropium respimat: Comparison of bronchodilator efficacy of 5 and 2.5 µg doses Source: International Congress 2014 – Asthma and COPD devices and treatments Year: 2014 Once-daily tiotropium respimat add-on to ICS±LABA improves control across asthma severities Source: International Congress 2014 – Bronchodilators for asthma and COPD Year: 2014 Mixed treatment analysis comparing tiotropium HandiHaler® and Respimat® Source: International Congress 2014 – Asthma and COPD devices and treatments Year: 2014 Cost-effectiveness of formoterol turbuhaler versus salbutamol as reliever therapy in asthma: results from the RELIEF worldwide randomised effectiveness study Source: Eur Respir J 2002; 20: Suppl. 38, 43s Year: 2002 High dose extrafine beclomethasone/formoterol via metered dose inhaler is effective and safe in asthmatics not controlled on medium-high dose of inhaled corticosteroids Source: International Congress 2014 – Asthma and COPD management Year: 2014 Efficacy of once-daily tiotropium Respimat in adults with asthma based on GINA Steps 2–5 Source: International Congress 2017 – Bronchial asthma management Year: 2017 Pharmacokinetic interaction of glycopyrronium bromide pMDI and formoterol pMDI: A randomized, open-label, single-dose, 4-way cross-over study Source: International Congress 2015 – New data on established treatments for asthma, COPD and bronchiectasis Year: 2015 Efficacy and safety of umeclidinium/vilanterol compared with umeclidinium or tiotropium in COPD Source: Annual Congress 2013 –Asthma and COPD management: novel clinical findings Year: 2013 Effect of interval between actuations of albuterol HFA inhalers on their aerosol characteristics Source: International Congress 2016 – Paediatric asthma: recurrent, persistent, or severe obstruction and lung function techniques Year: 2016