Related Experiment Video
Updated: Sep 16, 2026
Bronchial Thermoplasty: A Novel Therapeutic Approach to Severe Asthma
Published on: November 4, 2010
Budesonide/formoterol fumarate dihydrate versus budesonide with a novel suspension technology for uncontrolled
Alberto Papi1, Robert A Wise2, David J Jackson3
1Respiratory Medicine, Department of Translational Medicine, University of Ferrara, Ferrara, Italy.
Background:
Inhaled corticosteroid (ICS)/long-acting β2-agonist (LABA) therapy is a mainstay asthma treatment. LITHOS (clinicaltrials.gov identifier NCT05755906), a randomised phase 3 study, assessed efficacy and safety of low-dose budesonide/formoterol fumarate dihydrate (BFF) via a metered-dose inhaler (MDI) using Aerosphere co-suspension delivery technology (BFFA) versus low-dose budesonide via MDI using Aerosphere (BD).
Methods:
Participants (aged 12-80 years; N=374) with inadequately controlled asthma (seven-item Asthma Control Questionnaire score ≥1.5) despite low-dose ICS or ICS/LABA were randomised to 12 weeks of twice-daily BFF 160/10 μg (BFFA 160) or BD 160 μg (BD 160). End-points included change from baseline in forced expiratory volume in 1 s (FEV1) area under the curve from 0-3 h (AUC0-3) (primary) and morning pre-dose trough FEV1 (key secondary) at week 12, onset of action, severe exacerbation rates and safety/tolerability.
Results:
Least-square mean differences (95% CI) demonstrated that BFFA 160 provided superior lung function improvement versus BD 160 at week 12 for change from baseline in FEV1 AUC0-3 (200 (134-267) mL; p<0.0001) and morning pre-dose FEV1 (82 (20-144) mL; p=0.0096). Severe exacerbation rates were nominally reduced with BFFA 160 versus BD 160 (rate ratio (95% CI) 0.48 (0.23-0.97); unadjusted p=0.0419). No new or unexpected safety findings were observed; on-treatment adverse effects were comparable between treatments (BFFA 160, 18.4%; BD 160, 19.5%).
Conclusion:
These findings support the use of BFFA 160 twice daily with novel Aerosphere technology for the treatment of people aged 12-80 years with asthma inadequately controlled by low-dose ICS or ICS/LABA.
Related Concept Videos
01:23Inhaled Medications
01:19Antiasthma Drugs: Leukotriene Modifiers
Leukotriene modifiers work through two distinct mechanisms:
01:30Asthma-IV: Diagnostic and Management
Clinical Assessment for Asthma:
This is the first step in diagnosing and managing asthma. It includes:
01:24Antiasthma Drugs: Methylxanthines
Theophylline is thought to inhibit phosphodiesterase enzymes, increasing intracellular levels of cyclic adenosine monophosphate (cAMP) and cyclic guanosine monophosphate (cGMP). This rise in cAMP and cGMP concentrations stimulates cardiac function,...
01:25Antiasthma Drugs: β2-Adrenoceptor Agonists
One class of bronchodilators includes β2-adrenoceptor agonists. These agents target the β2-adrenoceptors located on bronchial smooth muscle cells. By stimulating these receptors, β2-agonists induce relaxation in these...
01:20Antiasthma Drugs: Muscarinic Receptor Antagonists
Antimuscarinic agents compete with ACh for the same binding site on the muscarinic receptors. By binding to these receptors, they inhibit the downstream effects of ACh and block the parasympathetic...