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formoterol + fluticasone propionate (Abriff / Formoterol Combi / KRP108)

✓ Approved

Zambon · ADRB2 · Small Molecule

What is formoterol + fluticasone propionate?

formoterol + fluticasone propionate is a small molecule developed by Zambon. It is approved for therapeutic indications via inhaled.

Drug Profile

Brand NamesAbriff, Formoterol Combi, KRP108
CompanyZambon
Drug ClassSmall Molecule
Molecular TargetADRB2, NR3C1
RouteInhaled
StatusApproved
Sources: ClinicalTrials.gov, Zambon

Mechanism of Action

Molecular Targets

formoterol + fluticasone propionate acts on 2 molecular targets:

ADRB2adrenoceptor beta 2 (B2AR, ARB2)
NR3C1nuclear receptor subfamily 3 group C member 1 (GR, GCCR)
Want deeper analysis?Noah AI can explain complex mechanisms and compare to similar drugs.

Therapeutic Indications

formoterol + fluticasone propionate is developed for 2 unique indications across 1 therapeutic area.

Therapeutic AreaConditionPhase
Respiratory, thoracic and mediastinal disordersAsthma✓ Approved
Respiratory, thoracic and mediastinal disordersChronic obstructive pulmonary diseasePhase III

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Adverse event mining for Breztri and Trelegy Ellipta based on the three international pharmacovigilance databases.

Wang Junyu J, Chen Kexu K, Yun Lu L, Xu Dexiang D

This study aimed to identify adverse drug reaction (ADR) risk signals associated with budesonide/glycopyrrolate/formoterol (Breztri) and fluticasone furoate/umeclidinium/vilanterol (Trelegy Ellipta) to support clinical decision-making and risk management. ADR reports related to Breztri and Trelegy Ellipta from the FDA Adverse Event Reporting System (FAERS) database, Japanese Adverse Drug Event Report (JADER) database and Canada Vigilance Adverse Reaction database (Q3 2004 to Q2 2024) were analyzed. After deduplication, reports were categorized using Medical Dictionary for Regulatory Activities (MedDRA) to obtain System Organ Class (SOC) and preferred terms (PTs). Disproportionality analysis was conducted using reporting odds ratio (ROR) and proportional reporting ratio methods. Analysis of 394 Breztri and 18,866 Trelegy Ellipta FAERS reports (predominantly consumer-submitted, U.S.-originated) identified 47 signals across 11 SOCs for Breztri (e.g., "Drug delivery system issue" ROR = 411.16, "Intentional device misuse" ROR = 410.69) and 160 signals across 15 SOCs for Trelegy (e.g., "Chronic eosinophilic rhinosinusitis" ROR = 187.65, "Foreign body in mouth" ROR = 107.67), revealing unlabeled risks like administration errors and packaging confusion. JADER data reinforced respiratory risks (Breztri: Chronic obstructive pulmonary disease (COPD) ROR = 516.8; Trelegy: gastrointestinal fungal infection ROR = 413.11) and device-independent safety signals (e.g., Trelegy urinary retention ROR = 28.81), while CVARD highlighted region-specific concerns including Trelegy-associated vasculitis (pulmonary vasculitis n = 29) and Breztri hypertension (ROR = 7.82). Cross-database convergence confirmed core anticholinergic/cardiopulmonary risks, yet divergent signals, FAERS' device errors, JADER's infection prominence, and CVARD's immunological events, underscore geographic heterogeneity in adverse reaction profiles, necessitating tailored risk management strategies for inhaler therapies. Inhalation device-related ADRs were observed, with Breztri showing higher incidence than Trelegy Ellipta, likely due to its more complex device usage. These findings highlight the need for enhanced patient education by healthcare providers to ensure proper device use in COPD treatment. Although core respiratory and anticholinergic risks are globally relevant, infection profiles, device complications, and rare immunological events exhibit significant geographic heterogeneity, necessitating tailored risk mitigation strategies aligned with regional pharmacovigilance patterns.

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People living with COPD are frequently inadequately treated due to underdiagnosis or misdiagnosis. The aim of this study was to evaluate the real-world performance of the beclomethasone dipropionate/formoterol fumarate/glycopyrronium (BDP/FF/G) fixed triple combination formulated in a dry powder inhaler (DPI) in improving symptoms, lung function, and adherence in moderate to severe COPD patients uncontrolled on dual therapies. We conducted a non-interventional, open-label, single-arm, multicenter, prospective study across 19 outpatient centers in Slovenia. The primary objective was to measure symptom improvement with the COPD Assessment Tool (CAT). A total of 359 patients with moderate to severe COPD (97% classified as GOLD E, frequent exacerbators) were followed for 24 weeks. There was a significant 6-point reduction in the CAT score after switching from dual therapies to BDP/FF/G inhalation powder (95% CI: -7.0 to -5.5; p < 0.0001). FEV1 increased by 110 mL (95% CI: 90-130; p < 0.0001) and FVC by 95 mL (95% CI: 65-120; p < 0.0001), reaching a statistically significant improvement of 2.5 percentage points in the FEV1/FVC quotient. The net improvement in dyspnea severity was 50.9% (95% CI 44.7%-57.2%), as assessed using the modified Medical Research Council (mMRC) Scale. Treatment adherence improved significantly after 6 months of triple therapy. In our cohort, switching uncontrolled moderate-to-severe COPD patients from dual therapy to BDP/FF/G fixed triple inhalation powder led to significant improvements in symptoms, lung function, dyspnea, sleep quality, and treatment adherence.

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Wang Rong R, Chen Juan J, Wang Li L, Gao Han H et al.

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Drug-related pulmonary fibrosis: A real-world pharmacovigilance study of the FDA Adverse Event Reporting System.

Jian Ruonan R, Yang Lei L, Guo Jingjing J, Shi Erxia E et al.

Pulmonary fibrosis (PF) can lead to respiratory distress, persistent dry cough, and a decline in quality of life, and may be life-threatening in severe cases. The aim is to mine and analyze drug-related PF signals, summarize potential risk medications, and provide references for clinical medication safety. This research accessed data from the US Food and Drug Administration Adverse Event Reporting System covering reports from January 2004 to September 2024. Proportional disproportionality methods were utilized to explore the relationship between drugs and PF, and to assess demographic information, drug-related PF risks, and the timing of PF onset. The Food and Drug Administration Adverse Event Reporting System database contained reports of 830 drugs associated with PF. Through disproportionality analysis and subsequent filtering, 33 drugs were identified as having significant risks. Fifteen antitumor and immunomodulatory drugs (45.45%) were noted, including bleomycin (reporting odds ratio [ROR] = 41.68), interferon gamma-1B (ROR = 12.11), and anagrelide (ROR = 6.63). Four cardiovascular system drugs (12.12%) included amiodarone (ROR = 41.92), dronedarone (ROR = 10.25), and simvastatin (ROR = 6.94). Four respiratory system drugs (12.12%) included indacaterol (ROR = 6.87), salmeterol/fluticasone (ROR = 4.30), and olodaterol (ROR = 3.76). Four antipathogenic microbial drugs (12.12%) included nitrofurantoin (ROR = 22.92), sulfasalazine (ROR = 5.69), and hydroxychloroquine (ROR = 3.51). Six other drugs (18.18%) included iodine-131 (ROR = 19.72), calcium carbonate (ROR = 8.59), and tamsulosin (ROR = 7.48). Amiodarone (Bayesian confidence propagation neural network [BCPNN] = 5.26), bleomycin (BCPNN = 4.95), and nitrofurantoin (BCPNN = 4.40) were the 3 drugs characterized by the greatest associated PF risk. The time to PF onset from antitumor and immunomodulatory drugs was significantly shorter than that from other drug types (P = .0082). The study identified 33 drugs showing disproportionality signals suggestive of potential associations with PF, most notably among antitumor and immunomodulatory agents, which exhibited a significantly shorter time to PF onset compared with other drug classes. The 3 drugs associated with the greatest PF risk were amiodarone, bleomycin, and nitrofurantoin. These findings highlight potential pharmacovigilance signals that warrant clinical vigilance and further validation through prospective studies.

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Huang Kunqin K, Xie Jianlei J, Zhang Fang F

To clarify the core mechanisms by which polysaccharides treat rheumatoid arthritis (RA) via gut microbiota modulation, and to systematically summarize their regulatory network and therapeutic potential. Methods: This study adopted a systematic review approach to synthesize existing evidence on polysaccharides in RA, focusing on their structural features, interactions with the gut microbiota, and downstream effects on host immunity and metabolism. Polysaccharides with specific structural features (e.g., plant-derived polysaccharides containing β-1,4 glycosidic bonds) selectively enhanced the abundance of gut probiotics (e.g., Bifidobacterium and Lactobacillus) by 15%-30%. They also promoted the production of short-chain fatty acids (SCFAs, such as acetate and propionate) through microbial degradation, increasing intestinal concentrations of these metabolites by more than 20%. These changes further regulated host metabolism and immune function, including restoring the balance between regulatory T cells (Treg) and T helper 17 cells (Th17), and inhibiting the nuclear factor-kappa B (NF-κB) signaling pathway to alleviate joint inflammation. Current research has critical clinical translation barriers: most evidence relies on in vitro experiments and animal models (e.g., collagen-induced arthritis (CIA) mice), while human clinical trials are restricted by small sample sizes and a lack of long-term follow-up data. Targeted interactions between polysaccharides and the gut microbiota represent a crucial pathway for RA intervention. Future research should focus on optimizing polysaccharide structural modification technologies, conducting large-scale multicenter clinical trials, and exploring personalized therapeutic strategies to promote the clinical translation of polysaccharides in RA treatment.

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Oligosaccharide prebiotics in functional foods and therapeutics: innovations and challenges.

Sandra K S KS, Vithalkar Megh Pravin MP, Beere Vishnusai V, Bharath H B HB et al.

Oligosaccharide prebiotics, such as inulin, fructooligosaccharides (FOS), and galactooligosaccharides (GOS), have demonstrated significant effects on gut microbiota and host health across in vitro, animal, and clinical studies. These studies consistently report an increase in beneficial bacteria, particularly Bifidobacterium and Lactobacillus, leading to higher production of short-chain fatty acids (SCFAs) such as acetate, propionate, and butyrate. These metabolic changes are linked to improved integrity of the epithelial barrier, reduced inflammatory signaling, modulation of immune responses, and enhanced metabolic balance. Biotechnological production methods, including enzymatic synthesis, microbial fermentation, and controlled depolymerization of plant polysaccharides, allow for precise control over the degree of polymerization and the types of glycosidic linkages. This control directly affects the fermentability, microbial selectivity, and functional effectiveness of the prebiotics. When incorporated into functional food systems, oligosaccharide prebiotics can enhance physicochemical properties such as texture, sweetness, and stability, all while maintaining their biological performance. Advanced delivery technologies, such as nano- and microencapsulation, improve thermal stability, resistance to gastrointestinal degradation, and targeted colon-specific release. Additionally, synbiotic formulations can further enhance the effectiveness of these prebiotics by promoting microbial colonization and sustained availability of SCFAs. Therapeutic benefits have been observed across various models of gastrointestinal health, metabolism, immune responses, and the gut-brain axis. These benefits involve mechanisms such as GPCR activation, histone deacetylase inhibition, and cytokine regulation. However, several challenges remain, including dose-dependent gastrointestinal intolerance, variability in individual microbiomes, degradation during processing, regulatory hurdles, and high costs of downstream processing. Overall, these findings highlight oligosaccharide prebiotics as versatile and scalable biotechnological ingredients, emphasizing the need for standardized production methods, precise dosing, and long-term clinical validation.

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