Flutiform (fluticasone/formoterol) / Kyorin, Mundipharma, Molex, Sanofi - LARVOL DELTA

A prospective, observational, real-world analysis of the effects of different as-needed low-dose inhaled corticosteroid–formoterol combinations in asthma control (ERS 2026) - "Objective:Global Initiative for Asthma steps 1-2 combined,asthma treatments include as-needed low-dose inhaled corticosteroids-formoterol.However,the comparative effectiveness of different ICS–formoterol combinations beyond budesonide remains underexplored in real-world settings.To explore the differences between different ICS treatments in patients with asthma, we determined asthma control,fractional exhaled nitric oxide levels,and the results of pulmonary function tests over 6 months using real-world combinations of budesonide-formoterol,beclomethasone-formoterol,fluticasone-formoterol and mometasone-formoterol. As-needed low-dose ICS–formoterol combinations as anti-inflammatory reliever alone ensure effective asthma control and maintain normal FeNO and FEV1 levels."

Clinical • Observational data • Real-world • Real-world evidence • Asthma • Immunology • Respiratory Diseases

EFFECTIVENESS OF COMBINATIONS OF FLUTICASONE/FORMOTEROL VS BUDESONIDE/FORMOTEROL IN PATIENTS OF MILD TO MODERATE BRONCHIAL ASTHMA: A SYSTEMATIC REVIEW AND META-ANALYSIS (CHEST 2026) - No abstract available

Retrospective data • Review • Asthma • Immunology • Respiratory Diseases

AIRLYMPUS: Study of Lunsekimig (SAR443765) Compared With Placebo in Adults With High-risk Asthma (clinicaltrials.gov) - P2 | N=556 | Active, not recruiting | Sponsor: Sanofi | Recruiting ➔ Active, not recruiting | N=1147 ➔ 556

Enrollment change • Enrollment closed • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

AIRLYMPUS: Study of Lunsekimig (SAR443765) Compared With Placebo in Adults With High-risk Asthma (clinicaltrials.gov) - P2 | N=1147 | Recruiting | Sponsor: Sanofi | N=673 ➔ 1147

Enrollment change • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

Reducing oral deposition of inhaled corticosteroids with a valved holding chamber: a quantitative study (ERS 2025) - "Participants inhaled Flutiform ® (FP/FM 250 μg) with and without a VHC (VORTEX ® ), followed by three mouth rinses to collect residual drug... VORTEX ® effectively reduces ICS deposition in the oral cavity by retaining larger particles, allowing finer particles to be inhaled. Consequently, VORTEX ® may help minimize ICS-related oropharyngeal side effects in patients requiring inhaled corticosteroids."

Candidiasis

Class 2 Medicines Recall: Flutiform 250 micrograms / 10 micrograms per actuation pressurised inhalation, suspension , CD Pharma Ltd, EL(25)A/35 (GOV.UK) - "CD Pharma Ltd have notified the MHRA of an error on the outer carton of the product for the batches listed in this notification. While the total active content statement is correct, the delivered dose content statement is incorrect. The other product details on the carton, including the name, strength and pharmaceutical form of the medicine are correct. The quality of the medicine is not impacted by the labelling defect."

Commercial • Chronic Obstructive Pulmonary Disease

Estimating the Greenhouse Gas Emissions of Outpatient Inhalers at Stanford Medicine (ATS 2025) - "The three most prescribed inhalers were albuterol sulfate, budesonide-formoterol, and fluticasone propionate; these metered-dose inhalers alone accounted for 92% of inhaler prescriptions and 90% of inhaler-related emissions over the study period. Metered-dose inhalers accounted for the majority of inhaler prescription orders and nearly all of the inhaler-related greenhouse gas emissions from selected Stanford Medicine outpatient clinics. The carbon equivalent emissions associated with metered-dose inhaler prescriptions at these clinics were equivalent to driving an average gasoline-powered passenger vehicle for 335,218 miles. While the increased use of propellant-free dry powder and soft mist inhalers may reduce the carbon footprint of respiratory care, individual prescribing decisions must be weighed against clinical and cost considerations."

Clinical • Immunology

Study of Lunsekimig (SAR443765) Compared With Placebo in Adults With High-risk Asthma (clinicaltrials.gov) - P2 | N=1000 | Recruiting | Sponsor: Sanofi

New P2 trial • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

Predictors of success/failure in the control of asthmatic smoking patients under conditions of clinical practice. (PubMed, J Asthma) - "An eosinophil count greater than 300 was the main predictor for achieving control. Fluticasone propionate/formoterol FP/FORM was associated with a greater likelihood of improving ACQ score."

Journal • Asthma • Eosinophilia • Immunology • Inflammation • Pulmonary Disease • Respiratory Diseases

Fixed-dose combination fluticasone/formoterol for asthma treatment in a real-world setting: meta-analysis of exacerbation rates and asthma control. (PubMed, Eur Clin Respir J) - "The findings of this meta-analysis confirm the effectiveness of FP/FORM for the treatment of asthma patients in a real-world setting beyond the limitations of RCTs."

Clinical • Journal • Real-world • Real-world evidence • Retrospective data • Review • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

Pharmacokinetic and Pharmacodynamic Comparison of Fluticasone Propionate/Formoterol Fumarate Administered via a Pressurized Metered-Dose Inhaler and a Novel Breath-Actuated Inhaler in Healthy Volunteers. (PubMed, J Aerosol Med Pulm Drug Deliv) - "Introduction: Fluticasone propionate/formoterol fumarate (fluticasone/formoterol) exposures, following administration of Flutiform K-haler, a breath-actuated inhaler (BAI), were compared with the Flutiform pressurized metered-dose inhaler (pMDI) with/without spacer in two healthy volunteer studies. Sponsor: Mundipharma Research Ltd. EudraCT 2012-003728-19 (Study 1) and 2013-000045-39 (Study 2)."

Journal • PK/PD data

Treatment persistence and exacerbations in patients with asthma initiating treatment with inhaled corticosteroids and beta-adrenergic agonists: retrospective cohort study. (PubMed, BMJ Open) - "Patients undergoing treatment with FP/FORM and FF/VI versus FP/SAL, BDP/FORM and BUD/FORM were associated with greater treatment adherence (persistence, MPR) and lower rates of exacerbations. However, further studies will be needed to strengthen the consistency of the results."

Journal • Retrospective data • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

Comparative Efficacy and Safety Between Budesonide-formoterol and Fluticasone-salmeterol Combination Inhalers for Asthma Management: Retrospective Analysis from the Common Data Model (KATRDIC 2021) - No abstract available

Retrospective data • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

The effect of combination inhaled therapy on ventilation distribution measured by SPECT/CT imaging in uncontrolled asthma. (PubMed, J Appl Physiol (1985)) - "Twenty-two symptomatic asthmatic participants underwent Single-Photon Emission Computed Tomography (SPECT)/CT imaging with Technegas, before and after 8-week fluticasone/formoterol (1000/40µg/day) treatment. SPECT ventilation defects are overall unresponsive to ICS/LABA, but the response is variable with improvement occurring when small airway dysfunction and ventilation defects are more severe. Persistent ventilation defects which correlate with Scond suggest that mechanisms such as non-ICS responsive inflammation or remodelling underlie these defects."

Journal • Asthma • Immunology • Inflammation • Pulmonary Disease • Respiratory Diseases

Assessing Adverse Drug Reactions Reported for New Respiratory Medications in the FDA Adverse Event Reporting System Database. (PubMed, Respir Care) - "Our findings suggest that the incidence of different adverse events experienced by patients in post-marketing reports resembles the incidence reported in pre-marketing clinical trials for COPD medications, except for fluticasone furoate/vilanterol, which has several differences."

Adverse drug reaction • Adverse events • Journal • Asthma • Chronic Obstructive Pulmonary Disease • Immunology • Pain • Pulmonary Disease • Respiratory Diseases

Comparative effectiveness and safety of different types of LABA/LAMA versus LABA/ICS fixed-dose combinations in COPD: a propensity score-inverse probability of treatment weighting cohort study. (PubMed, Chest) - "Both LABA/LAMAs versus salmeterol/fluticasone are associated with a lower exacerbation rate and pneumonia risk, but exhibit similar effectiveness and safety outcomes compared with formoterol/beclomethasone or formoterol/budesonide, suggesting that comparative effects may differ by individual components of the dual therapies in COPD."

Clinical • HEOR • Journal • Cardiovascular • Chronic Obstructive Pulmonary Disease • Immunology • Infectious Disease • Pneumonia • Pulmonary Disease • Respiratory Diseases

Regular treatment with formoterol and an inhaled corticosteroid versus regular treatment with salmeterol and an inhaled corticosteroid for chronic asthma: serious adverse events. (PubMed, Cochrane Database Syst Rev) - "Overall, for both adults and children, evidence is insufficient to show whether regular formoterol in combination with budesonide, beclomethasone, fluticasone, or mometasone has a different safety profile from salmeterol in combination with fluticasone or budesonide. Five deaths of any cause were reported across all studies and no deaths from asthma; this information is insufficient to permit any firm conclusions about the relative risks of mortality on combination formoterol in comparison to combination salmeterol inhalers. Evidence on all-cause non-fatal serious adverse events indicates that there is probably little to no difference between formoterol/budesonide and salmeterol/fluticasone inhalers. However events for the other formoterol combination inhalers were too few to allow conclusions. Only 46 non-fatal serious adverse events were thought to be asthma related."

Adverse events • Clinical • Journal • Review • Serious adverse event • Asthma • Immunology • Inflammation • Pulmonary Disease • Respiratory Diseases

Fluticasone/Formoterol compared withother ICS/LABAs in asthma: A systematic review. (PubMed, J Asthma) - "The present review compares the clinical efficacy and safety of formoterol fluticasone (FF) to other ICS/LABA combinations in asthmatics.MethodsThe review adhered to the general principles mentioned in the CRD guidance and the PRISMA statement...Only trials comparing the efficacy and safety of FF in comparision with Salmeterol/fluticasone (SF) or Budesonide/Formoterol (BF) were selected...Pneumonia risk was least with FF usage.ConclusionFF provides faster onset of action, numerically superior improvement in lung function and comparable asthma control than other ICS-LABA formulations. FF has better safety evidenced by lower occurrence of pneumonia."

Journal • Review • Asthma • Immunology • Infectious Disease • Pneumonia • Respiratory Diseases

Comparison of User Satisfaction and Preference with Inhalant Devices Between a Pressurized Metered-Dose Inhaler and Ellipta in Stable Asthma Patients: A Randomized, Crossover Study. (PubMed, Pulm Ther) - "Based on maintaining good ACL, adherence, and device operability, FFC pMDI showed significantly higher satisfaction and preference levels than VFC Ellipta in elderly persons."

Clinical • Journal • Asthma • Immunology • Respiratory Diseases

Use of Assist Devices to Actuate Pressurized Metered-Dose Inhalers in Elderly Patients with Asthma. (PubMed, Pulm Ther) - "Finger muscle strength should be considered when selecting a device for older patients with asthma, and the use of a pMDI assist device to push the canister is recommended in patients with weaker finger muscles."

Clinical • Journal • Asthma • Immunology • Respiratory Diseases

SWIFT: Efficacy and Safety of Flutiform K-haler in Patients With Uncontrolled Asthma Following Mid-dose ICS/LABA DPI Therapy (clinicaltrials.gov) - P3; N=20; Terminated; Sponsor: Mundipharma Korea Ltd; N=85 ➔ 20; Trial completion date: Jun 2021 ➔ Sep 2020; Not yet recruiting ➔ Terminated; Trial primary completion date: Apr 2021 ➔ Sep 2020; The Contract of K-haler products had been terminated between Mundipharma and provider. Therefore, this clinical trial was terminated early.

Clinical • Enrollment change • Trial completion date • Trial primary completion date • Trial termination • Asthma • Immunology • Respiratory Diseases

Budesonide/Formoterol Anti-Inflammatory Reliever and Maintenance or Fluticasone Propionate/Salmeterol Plus As-Needed, Short-Acting β Agonist: Real-World Effectiveness in pAtients without Optimally Controlled asThma (REACT) Study. (PubMed, Drug Des Devel Ther) - P=N/A | "In the prospective, observational, 16-week REACT study conducted between October 21, 2008 and May 12, 2011, we compared the real-world effectiveness of anti-inflammatory reliever and maintenance therapy with budesonide/formoterol (Symbicort Turbuhaler) and maintenance therapy with fixed-dose fluticasone/salmeterol (Seretide) plus as-needed, short-acting β agonists (SABAs) in Taiwanese patients with inadequate asthma control...Mean±SD ACQ-5 scores were 1.54±1.06 and 1.46±1.28 in the budesonide/formoterol and fluticasone/salmeterol groups, respectively...Collectively, results indicate the real-world effectiveness of budesonide/formoterol anti-inflammatory reliever and maintenance therapy is better than fixed-dose fluticasone/salmeterol plus as-needed SABA. ClinicalTrials.gov registration number: NCT00784953."

Clinical • Real-World Evidence • Asthma • Immunology • Respiratory Diseases

A PHASE III STUDY TO EVALUATE SAFETY AND EFFICACY OF FLUTICASONE/FORMOTEROL COMBINATION (FLUTIFORM AEROSOL) IN LONG-TERM ADMINISTRATION (24 WEEKS) IN JAPANESE PEDIATRIC PATIENTS WITH BRONCHIAL ASTHMA (PubMed, Arerugi) - "It was considered that FP/FM could be useful for long-term control of pediatric asthma."

Clinical • Journal • P3 data • Asthma • Pediatrics • Respiratory Diseases

Perspective on the Budgetary Impact of FP/FORM pMDI on Treatment and Management of Exacerbation in Moderate-to-Severe Asthma Patients in Singapore. (PubMed, Clinicoecon Outcomes Res) - "The use of fluticasone propionate/formoterol fumarate dihydrate (FP/FORM) pressurized metered-dose (pMDI, Flutiform), a type of inhaled corticosteroid (ICS) and long-acting β2 agonist (LABA) fixed-dose combination, has been associated with lower oral corticosteroid-requiring exacerbation rates than other ICS/LABA fixed-dose combinations, fluticasone propionate/salmeterol xinafoate (FP/SAL) and budesonide/formoterol fumarate (BUD/FORM)...In the scenario where patients switched from BUD/FORM, greater drug (S$2,572,797) and exacerbation management (S$256,781) cost savings were observed over 5 years. The analysis provides a perspective that the increased access to FP/FORM could help achieve drug and exacerbation cost savings for the treatment of moderate-to-severe asthma."

Clinical • Journal • Asthma • Respiratory Diseases

Risk of active tuberculosis among COPD patients treated with fixed combinations of long-acting beta2 agonists and inhaled corticosteroids. (PubMed, BMC Infect Dis) - "Fluticasone/salmeterol carried a higher risk of active TB compared with budesonide/formoterol among COPD patients."

Clinical • Journal • Chronic Obstructive Pulmonary Disease • Immunology • Infectious Disease • Tuberculosis