Assessment of Symptoms Control, Pulmonary Function and Related Quality of Life in Asthmatic Patients Treated with Extrafine Beclomethasone Dipropionate/Formoterol Fumarate 100/6 μg pMDI: Results of a Multicenter Observational Study in Romania (ALFRESCO Study)

Abstract

Introduction

Asthma treatment guidelines advocate the use of long-acting beta2-agonists (LABA) in addition to inhaled corticosteroids (ICS) in patients whose asthma is uncontrolled by ICS alone. This is the first study done in Romania, which collected the real-world data on the effects of Foster^® (extrafine beclomethasone dipropionate/formoterol fumarate BDP/FF in a pressurized metered-dose inhaler pMDI 100/6 μg formulation) in adult asthmatic population.

Objective

We aimed to assess the asthma symptoms control, pulmonary function and quality of life parameters in a heterogeneous Romanian asthmatic adult outpatient population, treated with extrafine BDP/FF 100/6 μg pMDI.

Methods

This was a prospective, multicenter, observational study involving 30 pulmonologists randomly selected from the Romanian healthcare system, which did not declare any competing interests. Recruitment period was Oct 2018 - Feb 2019, while the patients' observational period was 24 weeks. The study included poorly controlled and uncontrolled adult asthma outpatients treated with non-extrafine formulations medication, for which the treatment indication, according to Global Initiative for Asthma (GINA) 2018, was the use of an ICS-LABA combination. The study collected demographic data, smoking habits, comorbidities, data regarding asthma diagnosis, the evolution of asthma symptoms, spirometry, Asthma Control Questionnaire (ACQ-7) scoring test, current and concomitant treatment.

Results

Of 302 included patients, 290 completed the study. Pulmonary function parameters assessed during the trial (forced expiratory volume in one second - FEV1 and forced vital capacity - FVC) showed a significant improvement versus baseline (p<0.001). ACQ-7 score decreased significantly from 3.09±0.83 (visit 1) to 1.56±0.89 (visit 2) and to 1.09±0.81 (visit 3) (p<0.001). At the end of the study, 127 (43.79%) patients were well controlled (ACQ-7 score < 0.75).

Conclusion

This observational study demonstrates the effectiveness and safety of extrafine fixed combination of BDP/FF (100/6 μg) pMDI in Romanian adult asthma patients uncontrolled with non-extrafine medication in a real-world setting, leading to clinically and statistically improvements in asthma control and pulmonary function.

Keywords:

• asthma
• ACQ-7
• symptoms
• ICS/LABA
• maintenance and reliever therapy
• MART

Abbreviations

ACQ-7, Asthma Control Questionnaire-7 items; ADR, adverse drug reaction; BDP/FF, beclomethasone dipropionate/formoterol fumarate; BMI, body mass index; BUD/F, budesonide/formoterol; CRF, case report form; DBP, diastolic blood pressure; FEV1, forced expiratory volume in 1st second; FEV1/FVC, forced expiratory volume in 1st second/forced vital capacity; FVC, forced vital capacity; FLU/SAL, fluticasone/salmeterol; GINA, global initiative for asthma; HR, heart rate; ICF, informed consent form; ICS, inhaled corticosteroid; LABA, long-acting beta-2-agonist; LAMA, long-acting muscarinic antagonist; LTRA, leukotriene receptor antagonists; MART, maintenance and reliever therapy; NAMMDR, National Agency for Medicines and Medical Devices of Romania; NBCMMD, National Bioethics Committee for Medicine and Medical Devices; pMDI, pressurized metered-dose inhaler; SAE, serious adverse event; SABA, short-acting beta-2-agonist; SBP, systolic blood pressure; SD, standard deviation; SmPC, summary of product characteristics; V (1, 2, 3), visit (1, 2, 3).

Data Sharing Statement

The datasets generated and/or analyzed during the current study are not publicly available due to the fact that they belong to Chiesi, as Sponsor of the study, but are available from the corresponding author on reasonable request and with prior permission of Chiesi.

Ethics Approval and Informed Consent

The observational study was approved by the NBCMMD and NAMMD. All subjects have signed the ICF approved by NBCMMD.

Author Contributions

All authors made a significant contribution to the work reported, whether that is in the conception, study design, execution, acquisition of data, analysis and interpretation, or in all these areas; took part in drafting, revising or critically reviewing the article; gave final approval of the version to be published; have agreed on the journal to which the article has been submitted; and agree to be accountable for all aspects of the work.

Disclosure

RU reports speakers fees, congress fees, and clinical studies from Chiesi Romania, and Novartis Pharma Services Romania; speakers fees and congress fees from Angelini Pharmaceuticals, AstraZeneca Pharma, Boehringer Ingelheim, SERVIER PHARMA SRL, and Pfizer Romania SRL; speakers fees from Roche Romania and Lilly Oncology; clinical studies from GSK, Parexel, Mundipharma, Bayer, Aradigm, Sanofi, and Ab Science, outside the submitted work. OV is an employee of Medone Research (CRO) and its existing contract service includes fees for Clinical Research Services from Chiesi Romania SRL and Servier Pharma SRL. SB is an employee of Chiesi Romania. The authors report no other conflicts of interest in this work.

Additional information

Funding

The observational study was sponsored by Chiesi Romania.