fluticasone propionate HFA / Generic mfg. - LARVOL DELTA

Warren rebukes GSK for alleged 'money grab' after company pulled popular asthma med (Fierce Pharma) - "After removing Flovent HFA from the market, GSK and its partner substituted an authorized generic version with a lower list price—currently around $310—compared to the branded product’s $340...The spokesperson explained that GSK elected to launch authorized generics for Flovent HFA and its sister product Flovent Diskus to help maintain patient access to the drug, potentially at a lower cost...GSK in December removed four patents related to its inhaler products Advair, Annuity, Flovent and Ventolin from the FDA’s Orange Book following the U.S. Federal Trade Commission’s (FTC’s) recent crackdown on 'improper' listings."

Discontinued • Patent • Pricing • Asthma

ARGARG: Evaluating Long Acting Beta Agonists Used to Treat Asthma Among Those With Either Arg/Arg or Gly/Gly Genotypes (clinicaltrials.gov) - P=N/A | N=89 | Completed | Sponsor: Columbia University | Unknown status ➔ Completed

Trial completion • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

To Study Generic Fluticasone Propionate Inhalation Aerosol for the Treatment of Bronchial Asthma (clinicaltrials.gov) - P3 | N=790 | Recruiting | Sponsor: Glenmark Pharmaceuticals Ltd. India | Trial completion date: May 2024 ➔ Aug 2024

Trial completion date • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

To Study Generic Fluticasone Propionate Inhalation Aerosol for the Treatment of Bronchial Asthma (clinicaltrials.gov) - P3 | N=790 | Recruiting | Sponsor: Glenmark Pharmaceuticals Ltd. India

New P3 trial • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

Therapeutic Equivalence of Fluticasone Propionate Pressurized Metered Dose Inhaler, 110 mcg, to Flovent® HFA 110 mcg (clinicaltrials.gov) - P3; N=1902; Completed; Sponsor: Actavis Inc.; Recruiting ➔ Completed

Clinical • Trial completion • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

Therapeutic Equivalence of Fluticasone Propionate Pressurized Metered Dose Inhaler, 110 mcg, to Flovent® HFA 110 mcg (clinicaltrials.gov) - P3; N=1899; Recruiting; Sponsor: Actavis Inc.; Trial completion date: Dec 2020 ➔ May 2021; Trial primary completion date: Nov 2020 ➔ Mar 2021

Clinical • Trial completion date • Trial primary completion date • Asthma • Immunology • Respiratory Diseases

Therapeutic Equivalence of Fluticasone Propionate Pressurized Metered Dose Inhaler, 110 mcg, to Flovent® HFA 110 mcg (clinicaltrials.gov) - P3; N=1899; Recruiting; Sponsor: Actavis Inc.; Trial completion date: Aug 2020 ➔ Dec 2020; Trial primary completion date: Jun 2020 ➔ Nov 2020

Clinical • Trial completion date • Trial primary completion date • Asthma • Respiratory Diseases

A Randomized Comparison of the Pharmacokinetics and Bioavailability of Fluticasone Propionate Delivered via Xhance® Exhalation Delivery System Versus Flonase® Nasal Spray and Flovent® HFA Inhalational Aerosol. (PubMed, Clin Ther) - P1 | "Similar intranasal doses of Xhance® (372 μg) and Flonase® (400 μg) are clearly not bioequivalent. Systemic exposure is very low with all products. Systemic exposure is higher with Xhance® than with Flonase® and substantially lower than with Flovent® HFA 440 μg and, based on dose normalization, Flovent® HFA 220 μg. ClincalTrials.gov identifier: NCT02266927."

Clinical • Journal • PK/PD data • Asthma • Nasal Polyps • Respiratory Diseases

An Exploration of Factors Affecting In Vitro Deposition of Pharmaceutical Aerosols in the Alberta Idealized Throat. (PubMed, J Aerosol Med Pulm Drug Deliv) - "Three dry-powder inhalers (DPIs; Pulmicort Turbuhaler, Budelin Novolizer, and Easyhaler Budesonide) were examined at two insertion angles, one with the inhaler directed toward the back of the oral cavity, the other with the inhaler directed toward the tongue. Three pressurized metered-dose inhalers (pMDIs; QVAR, Ventolin Evohaler, and Flovent HFA) were examined considering the joint effects of insertion angle (as above) and relative humidity at low (15%-25%) and high (>95%) conditions...When oriented toward the back of the oral cavity, the filter dose decreased from 46.5% to 36.9% for Ventolin Evohaler (p = 0.005) and from 56.7% to 44.2% for Flovent HFA (p < 0.001) at high humidity relative to low. High humidity may cause a reduction in total in vitro lung doses for some pMDI aerosols."

Journal • Preclinical

6 signs of hope for COPD: New treatments for seniors suffering from COPD (Caring) - "Every patient is different, and treatment depends on how many exacerbations a person with COPD is experiencing, says Byron Thomashow...But since all three medications treat different aspects of the disease, many people do best taking all of them. Anticholinergics like Spiriva work by relaxing the smooth muscles, preventing airway spasms."

Media quote • Chronic Obstructive Pulmonary Disease

No effect of fluticasone propionate on linear growth in preschool children with asthma (Pediatr Int) - P=NA, N=28; Height standard deviation score difference was -0.0143 in group 1 and -0.2000 in group 2 and there was no significant difference for average cortisol (p=0.4381) or ACTH (p=0.5845) concentration; FP 100-200µg daily had no effect on linear growth or on the hypothalamic-pituitary-adrenal gland axis

Clinical data • Asthma

Relative potency of inhaled corticosteroids (clinicaltrials.gov) - P4, N=40; Active, not recruitng→Completed

Trial completion • Asthma

Environmental Control as Add-on Therapy in Childhood Asthma (clinicaltrials.gov) - P2; N=200; Not yet recruiting; Sponsor: Johns Hopkins University

New P2 trial • Asthma • Biosimilar • Immunology

Clinical study evaluating safety and efficacy of fluticasone furoate and fluticasone propionate in people with asthma (clinicaltrials.gov) - P3, N=330; Not yet open; New P3 trial

New trial • Asthma

ECATCh-Environmental Control as Add-on Therapy in Childhood Asthma (clinicaltrials.gov) - P2; N=200; Recruiting; Sponsor: Johns Hopkins University; Not yet recruiting ➔ Recruiting

Enrollment open • Asthma • Biosimilar • Immunology • Inflammation

Functional similarity of modified cascade impactor to deposit drug particles on cells. (PubMed, Int J Pharm) - "The objective of this study was to examine the uptake of HFA fluticasone (Flovent HFA) particles at various stages of the Next Generation Impactor (NGI) by human Calu-3 cell line derived from human bronchial respiratory epithelial cell monolayer...Particles of different size ranges showed different in vitro epithelial transport rates. This study highlights the need to develop in vitro test systems to determine the deposition of aerosol particles on cell monolayers by simultaneously considering aerodynamic properties."

Journal

"It's flovent hfa by @gsk." (@afrakt)

"Thankfully flovent HFA was within my price range otherwise my asthma might still be out of control and all I'd have is my Ventolin rescue inhaler." (@va3sbd)

Therapeutic Equivalence of Fluticasone Propionate Pressurized Metered Dose Inhaler, 110 mcg, to Flovent® HFA 110 mcg (clinicaltrials.gov) - P3; N=1899; Recruiting; Sponsor: Actavis Inc.; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open

Therapeutic Equivalence of Fluticasone Propionate Pressurized Metered Dose Inhaler, 110 mcg, to Flovent® HFA 110 mcg (clinicaltrials.gov) - P3; N=1899; Not yet recruiting; Sponsor: Actavis Inc.

Clinical • New P3 trial