Ease-of-use, preference, confidence, and satisfaction with Revolizer ® , a novel dry powder inhaler, in an Indian population

Context: While prescribing an inhaler device, it is important to take into account the usability, preference, confidence, and satisfaction of the patients. Aims: The present study assessed these parameters with Revolizer ® , a novel dry powder inhaler (DPI), in patients with obstructive airway diseases and in device-naïve healthy participants. Settings and Design: In this open-label, prospective, multicentre study with 100 participants [n = 50 healthy participants, n = 45 mild asthma patients, and n = 5 mild chronic obstructive pulmonary disease (COPD) patients], all participants were instructed and trained on the use of Revolizer and then the participants subsequently demonstrated the inhalation technique at two visits. Materials and Methods: The average time required to execute three correct consecutive attempts and the number of errors (including critical errors) were recorded. Participants were asked about the ease of use, preference, confidence, and satisfaction by means of a questionnaire at each visit. Results: The average time required by the participants to achieve three correct consecutive attempts at visit 1 was 3.75 ± 2.10 min, which significantly reduced at visit 2 (3.07 ± 1.32 min, P < 0.01). The number of errors decreased from visit 1 to visit 2. More than 85% participants found the Revolizer easy to use, and it was preferred by more than 75% participants. Revolizer scored high on the confidence and satisfaction of all participants at both visits. Conclusions: Revolizer is an easy-to-use and a preferred device in patients with mild asthma and COPD, as well as in healthy participants with no previous experience of using inhalation devices. The participants felt confident and satisfied using the Revolizer

A randomized, double-blind study comparing the efficacy and safety of a combination of formoterol and ciclesonide with ciclesonide alone in asthma subjects with moderate-to-severe airflow limitation

Context: The combination of inhaled corticosteroids (ICS) and long-acting beta-agonists (LABA) is widely used in the treatment of moderate-to-severe asthma uncontrolled by ICS alone. Aims: To evaluate the efficacy and safety of a new ICS-LABA combination inhaler containing Formoterol (F) and Ciclesonide (C). Settings and Design: A double-blind, double-dummy, parallel group fashion, multi-centric study. Subjects and Methods: A total of 169 asthma patients received Ciclesonide 80 μg once daily during a 4-week run-in period, after which, they were randomized to receive either C (80 μg) or a combination of F (4.5 μg) and C (80 μg) (FC) both delivered through a hydro-fluro-alkane pressurized-metered-dose inhaler as 1 puff twice daily, for 6 weeks. Statistical Analysis Used: Inter-group differences were compared using t-test for independent samples at a significance level of 5%. Results: From baseline, the improvements in forced expiratory volume in 1 s at 1, 3, and 6 weeks was significantly higher in the FC group compared to Group C (110 ml vs. 40 ml, 140 ml vs. 20 ml, and 110 ml vs. 40 ml, respectively, all P < 0.05). From baseline, the improvements in mean morning peak expiratory flow at 1, 3, and 6 weeks was significantly higher in the FC group compared to Group C (17 L/min vs.−3 L/min, 22 L/min vs. 3 L/min, and 30 ml vs. 8 L/min respectively, all P < 0.05). The changes in symptom scores were similar in both the groups. The adverse events in the FC group were not significantly different from those in the C group. Conclusions: FC provides better improvement than C alone in terms of lung function and symptoms without increased risk of adverse events in asthma patients

Scientific Rationale for Determining the Bioequivalence of Inhaled Drugs.

In recent years, pathways for the development and approval of bioequivalent inhaled products have been established for regulated markets, including the European Union (EU), and a number of orally inhaled products (OIPs) have been approved in the EU solely on the basis of in vitro and pharmacokinetic data. This review describes how these development pathways are structured and their implications for the treatment of airway diseases such as asthma. The EU guidance follows a stepwise approach that includes in vitro criteria as the first step. If all in vitro criteria are not met, the second step is based on pharmacokinetic evaluations, which include assessments of lung and systemic bioavailability. If all pharmacokinetic criteria are not met, the third step is based on clinical endpoint studies. In this review, the scientific rationale of the European Medicines Agency guidance for the development of bioequivalent OIPs is reviewed with the focus on the development of bioequivalent OIPs in the EU. Indeed, we discuss the advantages and disadvantages of the weight-of-evidence and stepwise approaches. The evidence indicates that the EU guidance is robust and, unlike clinical endpoint studies, the pharmacokinetic studies are far more sensitive to measure the minor differences, i.e. deposition and absorption rates, in drug delivery from the test and reference products and, thus, should be best suited for assessing bioequivalence. The acceptance range of the 90% confidence intervals for pharmacokinetic bioequivalence (i.e. 80-125% for both the area under the plasma concentration-time curve and maximum plasma concentration) represent appropriately conservative margins for ensuring equivalent safety and efficacy of the test and reference products