albuterol inhaled aerosol / Generic mfg. - LARVOL DELTA

Cipla has received the Food and Drug Administration’s permission for albuterol sulfate inhalation aerosol, 90 mcg per actuation, which is the generic of GlaxoSmithKline’s Ventolin HFA (Drug Store News) - "Albuterol sulfate inhalation aerosol is indicated for the treatment or prevention of bronchospasm in adult and pediatric patients aged four years and older with reversible obstructive airway disease, as well as for the prevention of exercise-induced bronchospasm in patients aged four years and older."

ANDA • Respiratory Diseases

ARRIVAL: Open-label Study to Assess Reduction of Background Asthma Medication While Sustaining Asthma Control and Clinical Remission With Tezepelumab in Patients 12-80yrs With Severe Asthma. (clinicaltrials.gov) - P3 | N=296 | Active, not recruiting | Sponsor: AstraZeneca | Recruiting ➔ Active, not recruiting

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

Functional Studies of Novel Genes Mutated in Primary Ciliary Dyskinesia II: Genotype to Phenotype (clinicaltrials.gov) - P1 | N=27 | Completed | Sponsor: University of North Carolina, Chapel Hill | Recruiting ➔ Completed

Trial completion • Otorhinolaryngology • Respiratory Diseases

BE Study of Albuterol Sulfate Inhalation Aerosol 90 mcg Per Actuation in Patients With Stable Mild Asthma (clinicaltrials.gov) - P3 | N=120 | Completed | Sponsor: Cipla Ltd. | Not yet recruiting ➔ Completed

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

ARRIVAL: Open-label Study to Assess Reduction of Background Asthma Medication While Sustaining Asthma Control and Clinical Remission With Tezepelumab in Patients 12-80yrs With Severe Asthma. (clinicaltrials.gov) - P3 | N=300 | Recruiting | Sponsor: AstraZeneca | Not yet recruiting ➔ Recruiting

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

Functional Studies of Novel Genes Mutated in Primary Ciliary Dyskinesia II: Genotype to Phenotype (clinicaltrials.gov) - P1 | N=30 | Recruiting | Sponsor: University of North Carolina, Chapel Hill | Trial completion date: Apr 2024 ➔ Apr 2025 | Trial primary completion date: Apr 2024 ➔ Apr 2025

Trial completion date • Trial primary completion date • Otorhinolaryngology • Respiratory Diseases

ARRIVAL: Open-label Study to Assess Reduction of Background Asthma Medication While Sustaining Asthma Control and Clinical Remission With Tezepelumab in Patients 12-80yrs With Severe Asthma. (clinicaltrials.gov) - P3 | N=300 | Not yet recruiting | Sponsor: AstraZeneca

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

BE Study of Albuterol Sulfate Inhalation Aerosol 90 mcg Per Actuation in Patients With Stable Mild Asthma (clinicaltrials.gov) - P3 | N=120 | Not yet recruiting | Sponsor: Cipla Ltd.

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

Using Filters to Estimate Regional Lung Deposition with Pressurized Metered Dose Inhalers. (PubMed, Pharm Res) - "The direct measurement of estimated regional deposition is possible when using the FBA. This method is far less resource intensive than existing methods and so may be useful both for comparison of generic alternatives and the development of innovative products."

Journal

Dry Powder Inhalers (DPIs) vs Metered Dose Inhaler (MDI) with valved spacer: Using Functional Respiratory Imaging (FRI) to assess modelled lung deposition in a COPD patient (ERS 2022) - "Drug delivery and airway deposition of MDI/spacer delivered Salbutamol (Ventolin HFA) was modelled using FRI with referenced measured particle and plume characteristics with an AeroChamber Plus Flow-Vu spacer. Symbicort (budesonide/formoterol) Turbohaler and Trelegy (fluticasone/umecledinium/vilanterol) Ellipta DPIs were similarly modelled... The FRI deposition profiles highlight that the MDI/AeroChamber Plus Flow-Vu spacer delivered a greater percentage of drug to the lung region than either of the two DPIs, irrespective of flow rate. This was reflected in much higher modelled oropharyngeal deposition for the two DPIs."

Clinical • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

SOBIstat-F (S-F), a Unique, Metered Dose Inhaler (MDI)-Based, Exhalation-Filtered Cardiopulmonary Resuscitation O2 Mask (CPROM) That Very Rapidly Initiates O2 and Bronchodilator Aerosol Therapy (Tx) While Protecting First Responders (FR) from COVID-19 (ATS 2022) - "Pharmacokinetics (PK) in a normal subject in 25, N=1 studies using various O2 flows (0-15 L/min) and 12 inhalation-synchronized albuterol puffs: Tmax @ 25’ averaged ~3.1 ng/mL (similar to GSK’s “approximately 3 ng/mL” in 12 normals, accepted by FDA for Ventolin HFA™ approval)... 1. S-F is a simple, compact device for simultaneously oxygenating (from a single source) and rapidly administering aerosol therapy (=/< 3’) in acute, severe asthma. It has been designed for ED, EMS and high end First Aid."

Asthma • Chronic Obstructive Pulmonary Disease • Immunology • Infectious Disease • Novel Coronavirus Disease • Pulmonary Disease • Respiratory Diseases

Functional Studies of Novel Genes Mutated in Primary Ciliary Dyskinesia II: Genotype to Phenotype (clinicaltrials.gov) - P1 | N=30 | Recruiting | Sponsor: University of North Carolina, Chapel Hill | Trial completion date: Apr 2025 ➔ Apr 2024 | Trial primary completion date: Apr 2025 ➔ Apr 2024

Trial completion date • Trial primary completion date • Otorhinolaryngology • Respiratory Diseases

"آلبوترول دارویی است که باعث باز شدن مجاری تنفسی می‌شود. این دارو تحت برندهای دیگری نیز به بازار عرضه می‌شود که نام های دیگر آن عبارتند از: ProAir HFA, ProAir RespiClick, Proventil HFA, Ventolin HFA..از وجود انسولین قلمی در داروخانه‌ّا اطمینان حاصل کنید@merck #blurrywyesight" (,@alidoki1)

Functional Studies of Novel Genes Mutated in Primary Ciliary Dyskinesia II: Genotype to Phenotype (clinicaltrials.gov) - P1; N=24; Recruiting; Sponsor: University of North Carolina, Chapel Hill

New P1 trial • Movement Disorders • Otorhinolaryngology • Respiratory Diseases

[VIRTUAL] Direct Medical and Mortality Related Costs Among COPD Patients in the United States, 2017-2018 (ISPOR 2021) - "Further, the 5 most commonly prescribed COPD-related prescription drugs were Spiriva, Symbicort, Ventolin HFA, Proair HFA, and Albuterol. Likewise, the most burdensome COPD-related prescription drugs among COPD patients were in a descending order Spiriva, Symbicort, Advair diskus, Bronchodilator combinations, and Breo ellipta...CONCLUSIONS This study provides updated estimates of the significant economic burden of COPD among a nationally representative sample of individuals across multiple payers in the US. Our results also quantify the significant mortality related costs of COPD as well as economic burden of comorbidly in COPD in the US."

Clinical • Chronic Obstructive Pulmonary Disease • Immunology • Respiratory Diseases

[VIRTUAL] Metered Dose Inhaler (MDI) with Valved Holding Chamber (VHC) vs Dry Powder Inhalers (DPIs): Using Functional Respiratory Imaging (FRI) to Assess Modelled Lung Deposition in an Asthmatic Patient (ATS 2021) - "Symbicort® (budesonide/formoterol) Turbohaler® and Seretide® (fluticasone/salmeterol) Diskus® DPIs were similarly modelled... The FRI deposition profiles highlight that the MDI/AeroChamber Plus® Flow-Vu® VHC system delivered an appreciably greater percentage of drug to the lung region than either of the two DPIs. The influence of inhalation flow profile was less with the MDI/VHC system and differed between the two DPIs."

Clinical • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

[VIRTUAL] Delivered Dose from a pMDI Albuterol HFA Operated Without Shaking Before Actuation (ATS 2021) - "We hypothesized that not shaking the albuterol HFA pMDI before actuation would result in an increase and decrease in delivered dose at the beginning and end of the canister life respectively. Three new albuterol pMDIs (Ventolin HFA, 90 µg/actuation; 200 doses) were operated without shaking before actuation. All nsDOSE were outside the 99%CI of the previously obtained DOSE. All recovered nsDOSE with exception of puffs 150-130 were at least 20% either higher or lower than the mean of the previously obtained DOSE. A concerning finding was that for the first 20 puffs nsDOSE was 2.5-6 fold higher than the previously studied mean DOSE, and the nsDOSE for the last 90 puffs was 40% or lower than the previously studied DOSE."

Asthma • Immunology • Inflammation • Pulmonary Disease • Respiratory Diseases

Teva Reports First Quarter 2021 Financial Results (Businesswire) - "ProAir (HFA and RespiClick) revenues in our North America segment in the first quarter of 2021 decreased by 9% to $54 million, compared to the first quarter of 2020. In January 2019, we launched our own ProAir authorized generic in the United States, following the launch of a generic version of Ventolin® HFA, another albuterol inhaler. Revenues from our ProAir authorized generic are included in 'generic products' above."

Sales • Asthma • Chronic Obstructive Pulmonary Disease • Respiratory Diseases

The ’whistle’ that helps you use your inhaler properly: Small ring that clips on to device and shrills when patients use it correctly could slash number of asthma attacks (Dailymail.co.uk) - "A small ring that clips on to an inhaler and whistles when patients use it correctly could slash the number of potentially fatal asthma attacks. The Clip-Tone device detects the speed and force with which patients are inhaling, and if this is sufficient enough to get the medicine into their lungs, it whistles....The device has now launched in the UK, and patients can get it for certain inhalers on an NHS prescription....The device can also be paired with an app which charts how well it’s being used....The product only fits Evohaler pumps used, for example, for Ventolin and Seretide inhalers, which are common in the UK."

Launch Europe • Asthma • Respiratory Diseases

[VIRTUAL] In vitro fine particle dose of drug formulation used in asthma & COPD (ERS 2020) - "The 7 pMDI drugs (Table 1) included 2 inhaled corticosteroids (Flovent and QVAR), 1 anticholinergic (Atrovent) and 4 bronchodilator formulations of salbutamol sulphate (SALB; Ventolin Evohaler sold in the UK, Ventolin HFA, Proventil and ProAir HFA sold in the USA). Mean FPD (μg ± standard deviation) FPD from the pMDI with VHC was equivalent or greater than pMDI alone. Although the 4 bronchodilator drug formulations delivered the same drug (SALB) the FPD differed by up to a factor of 2."

Preclinical • Asthma • Chronic Obstructive Pulmonary Disease • Respiratory Diseases

[VIRTUAL] Utilizing Capmedic Electronic Device to Measure and Improve Inhaler Technique in Clinic (ATS-I 2020) - "Patients then took a bronchodilator dose (Ventolin HFA), fitted with CapMedic, subjects in treatment group received guidance from CapMedic while those in control group did not... Patients using CapMedic with coaching displayed improved technique whereas those in control group acknowledged understanding the steps required but showed no significant improvement. Further, active guidance from CapMedic resulted in consistently correct inhaler technique (low variance). Thus, CapMedic may be used in clinical practice for assessing, teaching and improving inhaler technique in patients."

Late-breaking abstract • Asthma • Pediatrics • Respiratory Diseases

[VIRTUAL] Effect of Shake-Fire Delay on the Amount of Delivered Dose from pMDI Albuterol HFA (ATS-I 2020) - " Three new albuterol pMDIs (Ventolin HFA, 90 µg/actuation, 200 doses) operated without shake-fire delay were compared to another 3 inhalers of same brand/lot operated with a 30s shake-fire delay... The mean 99%CI DOSE without shake-fire delay was 904 µg 883-926 µg. DOSE with shake-fire delay was above, or below 99%CI 41%, and 41% of times respectively. DOSE with shake-fire delay was greater or lower than 20% than the mean DOSE of no shake-fire delay 16% and 24% of times respectively."

Asthma • Respiratory Diseases

[VIRTUAL] SOBIstat-F Emergency Response System for Severe Asthma: An Inexpensive, Very Rapid, Efficient, Simultaneous, Independent O2 and Bronchodilator Administration Device Optimized for Emergency Department, Emergency Medical Services and First Aid (ATS-I 2020) - "The SOBIstat System provides: 1. albuterol to the LRT equivalent to the Ventolin HFA pMDI used alone and optimally. 2."

Asthma • Cardiovascular • Movement Disorders • Respiratory Diseases

Effect of shake-fire delay on the amount of delivered dose from a pMDI albuterol HFA and valved holding chamber (ECFS 2020) - " Three new albuterol pMDIs (Ventolin HFA, 90 μg/actuation, 200 doses, GSK) connected to a VHC (Optichamber Diamond, Philips Respironics) and operated with a 30 s S-F delay were compared to 3 inhalers of same brand/lot connected to VHC and operated without S-F delay... Using an albuterol HFA pPMDI with 30 s shake-fire delay with VHC resulted in higher than expected DOSE at the beginning of canister life, and lower than expected DOSE at the end of the canister life. We recommend instructing patients using pMDI with VHC to re-shake the pMDI if it is not immediately actuated after having shaken it."

Cystic Fibrosis • Fibrosis • Genetic Disorders • Immunology • Respiratory Diseases

"In NY, The price for Ventolin HFA (16 day) supply is $58.00 (during Allergy Season I need it every 16 days)." (,@lorac328)

Pricing • Allergy • Immunology